WO2018005308A1 - Prognostic and diagnostic methods and herbal therapies for treating dermatoses, autoimmune diseases and inflammatory ailments - Google Patents

Prognostic and diagnostic methods and herbal therapies for treating dermatoses, autoimmune diseases and inflammatory ailments Download PDF

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Publication number
WO2018005308A1
WO2018005308A1 PCT/US2017/039177 US2017039177W WO2018005308A1 WO 2018005308 A1 WO2018005308 A1 WO 2018005308A1 US 2017039177 W US2017039177 W US 2017039177W WO 2018005308 A1 WO2018005308 A1 WO 2018005308A1
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WO
WIPO (PCT)
Prior art keywords
huang
grams
sheng
levels
prognostic
Prior art date
Application number
PCT/US2017/039177
Other languages
French (fr)
Inventor
Nadav Shraibom
Anu T. Singh
Manu Jaggi
Eran Steinberg
Ritu Verma
Alka MADAAN
Original Assignee
Sirbal Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US15/197,740 external-priority patent/US20170000836A1/en
Priority claimed from US15/197,745 external-priority patent/US20170000837A1/en
Application filed by Sirbal Ltd. filed Critical Sirbal Ltd.
Publication of WO2018005308A1 publication Critical patent/WO2018005308A1/en

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6881—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids from skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/52—Assays involving cytokines
    • G01N2333/525—Tumor necrosis factor [TNF]
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/52—Assays involving cytokines
    • G01N2333/54—Interleukins [IL]
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/20—Dermatological disorders
    • G01N2800/202—Dermatitis
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/20—Dermatological disorders
    • G01N2800/205—Scaling palpular diseases, e.g. psoriasis, pytiriasis

Definitions

  • diagnostic test kits configured to measure levels of certain panels of one or more diagnostic markers that are most indicative of a patient's disposition with a disease, condition or disorder, or combination or ailments.
  • prognostic test kits configured to measure levels of certain panels of one or more prognostic markers that are most indicative of a patient's tendency to respond safely and effectively to certain treatments or combinations of treatments for certain diseases, conditions or disorders.
  • Figure 6 schematically illustrates example steps on a tablet formulation process in accordance with certain embodiments.
  • Figure 8 illustrates a hair growth cycle and a hair fall control strategy in accordance with certain embodiments.
  • Figure 9 illustrates certain targets of combinations of Da Huang, Sheng Di Huang and Jin Yin Hua in accordance with certain embodiments.
  • Figure 10 illustrates certain putative mechanisms of combinations of Da Huang Sheng Di Huang and Jin Yin Hua in accordance with certain embodiments.
  • Figure 11 illustrates certain psoriasis target therapies for administration along with combinations of Da Huang Sheng Di Huang and Jin Yin Hua in accordance with certain embodiments.
  • a medicinal composition may be formulated as a shampoo and applied to the scalp.
  • the medicinal composition may be formulated as a shampoo, conditioner, cream, lotion, ointment or other topical scalp or hair treatment.
  • the medicinal composition may be formulated as a cream, lotion, ointment or other topical skin treatment.
  • Effective doses of the medicine may include 1.0wt.%-15.0wt.% of said herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
  • osteoarthritis seborrheic dermatitis, acne, colitis, skin lesions, diabetes, hypertension, allergies, asthma, capuche sarcoma, autoimmune, inflammation, dermatologic, cardiovascular, metabolic syndrome, hypotension, coronary artery disease, depression, lupus, sarcoidosis, muscular sclerosis, Crohn's disease, UV exposure, burns, warts, dandruff, seborrheic dandruff, chronic inflammation, seborrhea, keratosis, alopecia, hirsutism, capitis, melanoma or non-melanoma skin cancer, basal cell cancer (BCC), squamous cell cancer (SCC), scleroderma, dermatofibrosarcoma protuberans, Merkel cell carcinoma, Kaposi's sarcoma, keratoacanthoma, spindle cell tumors, sebaceous carcinomas, microcystic adnexal carcinoma, Page
  • the medical kit may also include a prognostic kit including a prognostic test kit and a prognostic indicator.
  • the prognostic test kit may be configured for measuring a level or combination of levels of one or more inflammatory cytokines, growth factors; cytokine receptors; ligand to surface markers, chemokines, protoangiogenic mediators, automicrobial proteins, neuropeptides, oxidative stress markers, dendritic cells (DC), plasmacytoid DC, monocytes, macrophages, histamines, T&B lymphocytes, or theranostic biomarkers, or combinations thereof, in a second bodily fluid or skin sample, or both, after a prognostic period of treatment.
  • the prognostic indicator may be configured for providing a prognostic result for the patient based on a comparison of said measured level or combination of levels in the first and second bodily fluid or skin sample, or both.
  • Effective doses of the medicinal formulation may include 2.5wt.%-5.0wt.% of said herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
  • autoimmune inflammation, dermatologic, cardiovascular, metabolic syndrome, hypotension, coronary artery disease, depression, lupus, sarcoidosis, muscular sclerosis, Crohn's disease, UV exposure, burns, warts, dandruff, seborrheic dandruff, chronic inflammation, seborrhea, keratosis, alopecia, hirsutism, capitis, melanoma or non-melanoma skin cancer, basal cell cancer (BCC), squamous cell cancer (SCC), scleroderma, dermatofibrosarcoma protuberans, Merkel cell carcinoma, Kaposi's sarcoma, keratoacanthoma, spindle cell tumors, sebaceous carcinomas, microcystic adnexal carcinoma, Paget's disease of the breast, atypical fibroxanthoma,
  • the medicinal composition may be formulated as a shampoo and applied to the scalp.
  • the method may further include administering, in combination with said medicinal composition that comprises effective doses between 20-160 mg/kg of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua, one or more additional medicines including an IL-12, IL-23, TNF alpha, JAK, STAT, IL-17, PDE4, p40 subunit of IL-12 and/or IL-23 and/or a humanized p40 monoclonal antibody, IL-22, IL-20, IL-23/pl9, JAK3, Thl, Thl7 and/or Th22 cell, IFN gamma, IL-17R, IL-19, sPLA2, NO (nitric oxide), VEGF, IL-24, kinase, tyrosine, topoisomerase, IL-1, IL-6, IL-8, BTK, SYK, ZAP-70, PI3KCD, AKT, HER-2, FLT-3, MAPKl, BRAF, MEK1, PD-1,
  • the method includes measuring a level or combination of levels of one or more of IL-5, IL-13, IL-17, IL-23, TNF-a, IL-6, IL-7, IL-13, GMCSF, MCP-1, IL-1- ⁇ , IL-l-RA, IL-8, IL-9, IL-10, IL-12, IL- 19, IL-20, IL-22, IL-24, IL-26, eotaxin, FGF- ⁇ , G-CSF, IFN- ⁇ , IP- 10, MIP-1, PDGF-RB, PDGF- BB, MIP-1- ⁇ , RANTES, VEGF, JAK, JAKl, JAK3, MPO (myeloperoxidase), p38kinase, BRAF, BRAF V599E, KRAS, EGFR, ALK, TRPV1, TRPA1, MRGPRA3, PAR2, mucunain or other proteases, chloroquine, pruritogen, cowhage, sap
  • Effective doses may include 1.0wt.%-15.0wt.% of said herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
  • the medicinal formulation includes shampoo, conditioner, cream, lotion, ointment or other topical skin, scalp or hair treatment or a pill, skin patch, gel, injection pen, subdermal injection packet, IV fluid package, tablet, capsule, lipid carrier, nano-crystal or other nano-particulate formulation, subcutaneous insert, or stent, or combinations thereof, said medicinal formulation comprising a predetermined number of one or more effective doses, each effective dose including between 20-160 mg/kg of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
  • the medicinal formulation includes shampoo, conditioner, cream, lotion, ointment or other topical skin, scalp or hair treatment or a pill, skin patch, gel, injection pen, subdermal injection packet, IV fluid package, tablet, capsule, lipid carrier, nano-crystal or other nano-particulate formulation, subcutaneous insert, or stent, or combinations thereof.
  • the medicinal formulation includes a predetermined number of one or more effective doses, each effective dose including between 1.0wt.%-15wt.% of an herbal combination of Da Huang, Sheng di Huang and Jin Yin Hua.
  • Effective doses may include 2.5wt.%-5.0wt.% of said herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
  • Herbal formulations including a majority to an entirety of the three herbs Da Huang, Sheng Di Huang and Jin Yin Hua have demonstrated significant inhibitory effects on secretion of TNF-a, TARC and VEGF in keratinocytes (HaCaT), considerable downregulation of IL-6 in RAW264.7 cells and IgE in human myeloma cell line-U-266, as well as inhibition of JAK-l/JAK-3.
  • lotion, cream, gel, shampoo, foam, subdermal injections, IV, and oral formulations are provided herein.
  • Diagnostic test kits are provided in accordance with certain embodiments that include diagnosis-based treatments, diagnostic testing that involve novel markers or novel combinations of markers or novel reagents or combinations thereof.
  • An example of a diagnostic test kit in accordance with certain embodiments includes a test kit for measuring certain markers in patient bodily samples (e.g., serum or sera from skin washings, liquid blood serum, keritinocytes, or fibroblasts, or combinations thereof).
  • the example test kit may further include an indicator for communicating a diagnosis to the patient based on the results of the measuring and known correlations between levels of markers and predispositions with one or more diseases, conditions, ailments or disorders.
  • a shampoo, cream, lotion, pills, skin patches, gel, nanogel, injection pens, ointments, subdermal injections, IV bags, tablets, capsules, nano-lipid carriers, nano-chrystals, nano-particulates, subcutaneous implants, stents, or combinations thereof, may be provided with the test kit or may be advised based on the diagnosis, for administering treatment to the patient based on the diagnosis.
  • Such developed therapies may include one or more of Etanercept, Betamethotrexate, Methotrexate, 5-fluoroviacil, Paclitaxel, Adriamycin (doxorubicin), Etoposide, 5-fluorourasil, Docetaxil, Vincristine, Irinotecan, Methylprednisolone, Carboplatin, dacarbazine, Acitretin, Glycyrrhizin, Paeonia lactiflora, Glycyrrhiza uralensis, Mahonia aquafolium, Aloe vera, Indigo naturalis, Kaku nut oil, Camptotheca acuminatanut, Calcipotriol, tazarotene, Otezla, Embrel, Humira, Cinzia, Cosentyx, Remicade, Simponi, Taltz, Steroids, Tacrolimus, Prograf,
  • An herbal medicinal composition may be administered alone or in combination with an established treatment regimen such as any of those described herein before, during or after administration of the established regimen.
  • An example two herb combination in accordance with certain embodiments includes Da Huang and Sheng Di Huang. Another two herb combination includes Da Huang and Jin Yin Hua. Another two herb combination includes Sheng Di Huang and Jin Yin Hua. A three herb combination includes Da Huang, Sheng Di Huang and Jin Yin Hua.
  • Figure 4 illustrates the effect on live cells of five combinations of herbs each in two concentrations 1 :40 and 1 :80.
  • Cal includes a combination of all eighteen herbs
  • C2 includes a combination of Jin Yin Hua, Da Huang, Mu Dan Pi and Di Gu Pi
  • C3 includes a combination of Da Huang, Sheng Di Huang and Jin Yin Hua
  • C4 and C5 include combinations of the other eleven herbs (Zi Cao, Xuan Shen, Shi Gao, Bai Shao, Chi Shao, Hong Hua, Da Qing Ye, Qing Dai, Bai Zhu, Shi Wei and Rou Gui) of the eighteen herbs, i.e., not in combination with any of the seven herbs (Sheng Di Huang, Da Huang, Jin Yin Hua, Mu Dan Pi, Di Gu Pi, Xian He Cao and Chun Gen Pi).
  • a treatment method in accordance with certain embodiments may include administering periodic doses of Pemetrexed, Pralatrexate, Methotrexate sodium, Pemetrexed Disodium or a folate analog metabolic inhibitor, alone or in combination with methotrexate, and/or another known treatment regimen described herein or as understood by those skilled in the art, along with an herbal combination of one or more of Da Huang, Sheng Di Huang, and Jin Yin Hua, and/or one or more of the other herbs described herein, for treating a patient with psoriasis, eczema, melanoma, inflammation or another inflammatory or autoimmune disease or form of cancer that is known to be effectively treated with methotrexate or another known treatment described herein or a discovered treatment such as for treating cancer of the breast, skin, bladder, head and neck, or lung, osteosarcoma, lymphoma, or trophoblastic neoplasms, or inflammation, or an autoimmune disease such as rheumatoid arthritis,
  • a very low dose example for a 100 kg patient includes 0.4 grams Da Huang, 0.4 grams Jin Yin Hua and 1.2 grams Sheng Di Huang.
  • a medium dose example includes 0.2 grams Da Huang, 0.2 grams Jin Yin Hua and 0.6 grams Sheng Di Huang.
  • a treatment regimen may include 1-10 gram daily doses of combinations of Da Huang, Sheng Di Huang and Jin Yin Hua.
  • a treatment regimen may include 2-5 gram daily doses, or approximately 3 gram daily doses.
  • 1.5 gram doses may be administered twice daily, i.e., 1.5 grams twice a day.
  • a total daily dose may be administered in the form of four (4) tablets, e.g., 2 tablets, twice a day, of 1.0 gram each containing 750 mg of a combination of Da Huang, Sheng Di Huang and Jin Yin Hua as well as 250 mg of excipients.
  • a psoriasis treatment regimen may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with an IL- 23/pl9 inhibitor.
  • an Alzheimer's or Parkinson's treatment regimen may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua, alone, or along with another approved Alzheimer's or Parkinson's treatment.
  • Desatinib and/or another LYN, BTK and/or ABL inhibitor, and/or Fostamatinib and/or another SYK, FLT3, KIT, LCK, JAL1, JAK3, PLC, AKT and/or BCR inhibitor, and/or Idelalisib (GS-1101) or another P13K delta inhibitor, and/or Ibrutinib and/or another BTK inhibitor and/or Gefitinib and/or another Zap 70 inhibitor, and/or Dasatinib and/or another Lyn inhibitor, or another approved treatment for CLL and/or another leukemia or other cancer medication may be supplemented by administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua.
  • a medicinal tablet composition for example for oral administration that may include one or more of the following further ingredients: 125 mg of MCC (Avicel), 20 mg of talc powder, 30 mg of aerosol 200, 10 mg of croscarmellose sodium and/or 30 mg of PVPK 30.
  • This example may also include one or more of the following lubrication ingredients: 20 mg of croscarmellose sodium, 5 mg of aerosol 200, 20 mg of talc powder and/or 10 mg of magnesium sterate.
  • a medicinal cream is also provided for topical administration that includes the above active herbal combination ingredient, in aqueous extract and in an example concentration of 2.5%, and one or more of the following further ingredients: till oil, cetostearyl alcohol, arlacel 165, light liquid paraffin, cresmer wax EW, stearyl stearate, butyl hydroxyl toluene, propylene glycol, sodium methyl paraben, sodium propyl paraben, glycerol, sandalwood oil.
  • a cream placebo may be formulated for clinical trials that substitutes F-24 chocolate brown color TAS and brilliant blue color for the above active herbal combination ingredient.
  • NSAIDs such as ibuprofen, naproxen and aspirin, other non-steroidal anti-inflammatories, acetaminophen, and/or steroidal anti -inflammatories may be combined with an herbal combination of one or more of Da Huang, Sheng Di Huang and Jin Yin Hua and/or one or more other herbs or molecules described herein, with or without administration of a known or discovered treatment, before, during or after the herbal treatment, to treat inflammation or other ailments that are commonly treatable with NSAIDs, including chronic pain.
  • Formulations may be prepared for oral or topical administration as long release, lipidized dosage compositions or as short release non-lipidized formulas.
  • a cooking process may be performed as in the example of Figures 5A-5B.
  • a step 502 in a cooking process may include taking about 25-30 grams of a first herb, e.g., da Huang, and a second herb, e.g., Jin Yin Hua, and grinding in a mixer grinder for three to five minutes or until a fine powder has been mixed and ground.
  • a step 504 in the process may include taking about 75-80 grams of a third herb, e.g., Sheng di Huang, and grinding in a mixer grinder for three to five minutes or until a fine powder has been mixed and ground.
  • a shampoo in accordance with certain embodiments includes one or more active herbs or herbal extracts or emotives that are described in several examples herein. These one or more active herbs or herbal extracts serve to promote treatment of certain hair and scalp conditions such as psoriasis, eczema, dermatitis, melanoma, hair loss and other hair or scalp conditions described herein or understood by those skilled in the art.
  • a preservative may be included in a shampoo in accordance with certain embodiments. The preservative may be configured to prevent microbial growth. Examples of preservatives that may be contained in a shampoo in accordance with certain embodiments include paraben free, formaldehyde donor free and halogenated free.
  • Figure 9 schematically illustrates certain targets of medicinal compositions including combinations of Da Huang, Sheng Di Huang and Jin Yin Hua (3HX), in accordance with certain embodiments.
  • Figure 9 illustrates a hyper proliferation of keratinocytes 902, e.g., as may be present in a patient suffering with an inflammatory skin condition, or melanoma, or an
  • a known or discovered treatment regimen is supplemented with a low dose formula including 3.3-20 grams of Jin Yin Hua and 10-60 grams of Sheng Di Huang.
  • a known or discovered treatment regimen is supplemented with a low dose formula including the one herb including 3.3-30 grams of Jin Yin Hua.
  • a known or discovered treatment regimen is supplemented with a low dose formula including the one herb including 10-90 grams of Sheng Di Huang.
  • a known or discovered treatment regimen is supplemented with a medium dose formula including the three herbs including 10-100 grams of Da Huang, 25-250 grams of Sheng Di Huang, and 10-100 grams of Jin Yin Hua.
  • a known or discovered treatment regimen is supplemented with a medium dose formula including 10-100 grams of Da Huang and 25-250 grams of Sheng Di Huang.
  • a known or discovered treatment regimen is supplemented with a medium dose formula including 10-100 grams of Jin Yin Hua and 25-250 grams of Sheng Di Huang.
  • a known or discovered treatment regimen is supplemented with a low dose herbal formula that includes 3.3-10 grams of Da Huang, and 13.3-40 grams of Sheng Di Huang in about 100-300 grams of water, or in dry or lipidized form for oral, topical, sub-dermal or IV administration.
  • a known or discovered treatment regimen is supplemented with a medium dose herbal formula that includes 15-100 grams of Da Huang and 45-300 grams of Sheng Di Huang in about 600-4000 grams of water, or in dry or lipidized form for oral, topical, sub- dermal or IV administration.
  • a known or discovered treatment regiment is supplemented with a low dose herbal formula that includes 0.25-25 grams of Sheng Di Huang in about 2.5-250 grams of water, or in dry or lipidized form for oral, topical, sub-dermal or IV administration.
  • a known or discovered treatment regimen is supplemented with a low dose herbal formula that includes 0.20-0.50 grams of Da Huang and 0.40-1.0 grams of Sheng Di Huang in about 6-50 grams of water, or in dry or lipidized form for oral, topical, sub-dermal or IV administration.
  • Surprise effectiveness is also provided by very low dose herbal combinations of Da Huang, Sheng Di Huang and Jin Yin Hua and by combinations of low doses of one or more of Da Huang, Sheng Di Huang and JinYin Hua with certain herbal extracts, molecules and/or known medicines. Examples includes
  • An example nanogel or nano-particulate lotion, cream, ointment or shampoo formulation may include carbopol ultraze 21/polymer surfactant. Triethanolomine may be advantageously used to convert lotion to gel and/or to neutralize a level of ph to between 5-8, 5.5-7.5 or 6-7 for topical application.

Abstract

A medical kit for psoriasis, eczema or other inflammatory and/or autoimmune skin ailment, or for melanoma, BCC or other cancers, or leukemia, includes a swab or other tool for collecting skin samples, a multiplex cytokine assay for measuring levels of several cytokines, including IL-17, IL-23 and TNF-alpha, an indicator of a diagnostic test result, and a shampoo, lotion, cream ointment or nanogel or other topical medicinal formulation that includes a dosage composition including 20-160 mg/kg doses of an herbal combination of Sheng Di Huang, Da Huang and Jin Yin with an average particulate size that is less than 450 nm.

Description

PROGNOSTIC AND DIAGNOSTIC METHODS AND HERBAL THERAPIES FOR TREATING DERMATOSES, AUTOIMMUNE DISEASES AND INFLAMMATORY AILMENTS
PRIORITY
This application claims the benefit of priority to United States patent applications serial numbers 15/197,740 and 15/197,745, each filed June 29, 2016.
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to disease treatments, including treatments for psoriasis, eczema, melanoma and other skin disorders, inflammatory and autoimmune ailments and cancer. More specifically it concerns the use of combinations of certain herbs, certain herbal extracts and/or certain herbal molecular components alone or in combination with known antimetabolite, antifolate, anti-inflammatory, or autoimmune treatments and other known and/or described treatments, particularly to treat psoriasis or reduce psoriatic suffering and symptoms, or to treat eczema or blisters, redness or eczematic soreness or itching or crusty skin caused by eczema, or to treat inflammation or an inflammatory condition, or to treat melanoma or other cancer, or to reduce white cell count, tumor size or painfulness from cancer, or to treat or reduce suffering from another skin ailment, or to treat an autoimmune disease or disorder, or otherwise to treat or to reduce suffering from one or more of diseases causing or stemming from inflammation or autoimmune disease or to administer along with a known or discovered treatment to enhance effectiveness, reduce toxicity or side effects and/or to facilitate weening from a known or discovered treatment. Examples include herbal formulas including one or more of, or a combination of two or more of, Da Huang, Sheng Di Huang, and Jin Yin Hua, and/or
combinations including one or more of Mu Dan Pi, Di Gu Pi, Xian He Cao, and/or Chun Gen Pi., and/or another herb, molecule or extract, or combination of herbs, molecules or extracts described herein.
2. Description of the Related Art
Herbal medicines are prevalent, and serve the medicinal needs of a large population around the world. The global herbal medicine market is currently worth around $30 billion. There is also an increased effort for the isolation of bioactive phytochemicals from herbs for their possible usefulness in the control of various ailments. It is desired to provide more reliable medical kits that include diagnostic test kits and medicines for treating a patient in accordance with an indication provided by the test kit.
It is desired to provide more reliable prognostic kits that include medicines and prognostic measuring devices and prognostic indicators. With such prognostic kits, more effective stratification of patients is provided for certain treatments for certain conditions such that patients can be treated more safely and effectively.
It is therefore desired to provide diagnostic test kits configured to measure levels of certain panels of one or more diagnostic markers that are most indicative of a patient's disposition with a disease, condition or disorder, or combination or ailments.
It is also desired to provide prognostic test kits configured to measure levels of certain panels of one or more prognostic markers that are most indicative of a patient's tendency to respond safely and effectively to certain treatments or combinations of treatments for certain diseases, conditions or disorders.
It is also desired to have an herbal and/or molecular combination that may be administered to a patient as a safe and effective treatment of a condition.
It is also desired to have an herbal and/or molecular combination that may be administered to a patient before, during and/or after a typical, known or discovered treatment regimen to enhance the effectiveness of such known or discovered treatments, and/or to reduce side effects of such known or discovered treatments and/or for weening a patient from a dependence on such known or discovered treatments.
BRIEF DESCRIPTION OF THE DRAWINGS
Figures 1-3 show plots of growth of cancer cells versus dilution factor for each of 18 different herbs.
Figure 4 is a bar chart that illustrates the effects of certain herbs and combinations of herbs on live cancer cells.
Figures 5A-5B schematically illustrate example steps in a cooking process in accordance with certain embodiments.
Figure 6 schematically illustrates example steps on a tablet formulation process in accordance with certain embodiments.
Figure 7 illustrates the components of a shampoo in accordance with certain embodiments.
Figure 8 illustrates a hair growth cycle and a hair fall control strategy in accordance with certain embodiments. Figure 9 illustrates certain targets of combinations of Da Huang, Sheng Di Huang and Jin Yin Hua in accordance with certain embodiments.
Figure 10 illustrates certain putative mechanisms of combinations of Da Huang Sheng Di Huang and Jin Yin Hua in accordance with certain embodiments.
Figure 11 illustrates certain psoriasis target therapies for administration along with combinations of Da Huang Sheng Di Huang and Jin Yin Hua in accordance with certain embodiments.
Figure 12 illustrates certain rheumatoid arthritis (RA) target therapies for administration along with combinations of Da Huang Sheng Di Huang and Jin Yin Hua in accordance with certain embodiments.
Figure 13 illustrates certain chronic lymphocytic leukemia (CLL) target therapies for administration along with combinations of Da Huang Sheng Di Huang and Jin Yin Hua in accordance with certain embodiments.
Figure 14 illustrates certain Alzheimer's neuro-inflammation target therapies for administration along with combinations of Da Huang Sheng Di Huang and Jin Yin Hua in accordance with certain embodiments.
DETAILED DESCRIPTIONS OF THE EMBODIMENTS
A method is provided for treating scalp psoriasis, dermatitis, atopic dermatitis, eczema, herpes, shingles, rheumatoid arthritis (RA), arthritic psoriasis/psoriatic arthritis, Alzheimer's, Parkinson's, irritable bowel syndrome (IBS), colitis, prostitis, vasculitis, osteoarthritis, seborrheic dermatitis, acne, colitis, skin lesions, diabetes, hypertension, allergies, asthma, capuche sarcoma, autoimmune, inflammation, dermatologic, cardiovascular, metabolic syndrome, hypotension, coronary artery disease, depression, lupus, sarcoidosis, muscular sclerosis, Crohn's disease, UV exposure, burns, warts, dandruff, seborrheic dandruff, chronic inflammation, seborrhea, keratosis, alopecia, hirsutism, capitis, melanoma or non-melanoma skin cancer, basal cell cancer (BCC), squamous cell cancer (SCC), scleroderma, dermatofibrosarcoma protuberans, Merkel cell carcinoma, Kaposi's sarcoma, keratoacanthoma, spindle cell tumors, sebaceous carcinomas, microcystic adnexal carcinoma, Paget's disease of the breast, atypical fibroxanthoma,
leiomyosarcoma, and angiosarcoma, Marjolin's ulcers, kidney failure, nerve damage caused by a skin condition, or skin burrowing mites, or a skin ailment, lesion or sore, particularly of the scalp and also for other skin regions affected by an ailment that is susceptible to topical or hair treatment, as well as hair fall or hair loss conditions, or combinations thereof. The method includes measuring an elevated or low level, or higher or lower than expected level, or higher or lower than a normal or threshold level, of each of one or more of, or combinations of levels of two or three or multiple or several or many or a panel of one or more inflammatory cytokines, growth factors; cytokine receptors; ligand to surface markers, chemokines, protoangiogenic mediators, automicrobial proteins, neuropeptides, oxidative stress markers, dendritic cells (DC),
plasmacytoid DC, monocytes, macrophages, histamines, T&B lymphocytes, or theranostic biomarkers, or combinations thereof, in a first bodily fluid sample or skin sample, or both, extracted from a patient. The method further includes formulating a diagnosis of scalp psoriasis, dermatitis, atopic dermatitis, eczema, herpes, shingles, rheumatoid arthritis (RA), arthritic psoriasis/psoriatic arthritis, Alzheimer's, Parkinson's, irritable bowel syndrome (IBS), colitis, prostitis, vasculitis, osteoarthritis, seborrheic dermatitis, acne, colitis, skin lesions, diabetes, hypertension, allergies, asthma, capuche sarcoma, autoimmune, inflammation, dermatologic, cardiovascular, metabolic syndrome, hypotension, coronary artery disease, depression, lupus, sarcoidosis, muscular sclerosis, Crohn's disease, UV exposure, burns, warts, dandruff, seborrheic dandruff, chronic inflammation, seborrhea, keratosis, alopecia, hirsutism, capitis, melanoma or non-melanoma skin cancer, basal cell cancer (BCC), squamous cell cancer (SCC), scleroderma, dermatofibrosarcoma protuberans, Merkel cell carcinoma, Kaposi's sarcoma, keratoacanthoma, spindle cell tumors, sebaceous carcinomas, microcystic adnexal carcinoma, Paget's disease of the breast, atypical fibroxanthoma, leiomyosarcoma, and angiosarcoma, Marjolin's ulcers, kidney failure, nerve damage caused by a skin condition, or skin burrowing mites, or a skin ailment, lesion or sore, particularly of the scalp and also for other skin regions affected by an ailment that is susceptible to topical or hair treatment, as well as hair fall or hair loss conditions, or combinations thereof, for the patient based on said measuring said elevated and/or low level or combination of levels. The method further includes administering a medicinal composition that comprises an effective dose between 20-160 mg/kg of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua to the patient.
Another method is provided for treating scalp psoriasis, dermatitis, atopic dermatitis, eczema, herpes, shingles, rheumatoid arthritis (RA), arthritic psoriasis/psoriatic arthritis,
Alzheimer's, Parkinson's, irritable bowel syndrome (IBS), colitis, prostitis, vasculitis, osteoarthritis, seborrheic dermatitis, acne, colitis, skin lesions, diabetes, hypertension, allergies, asthma, capuche sarcoma, autoimmune, inflammation, dermatologic, cardiovascular, metabolic syndrome, hypotension, coronary artery disease, depression, lupus, sarcoidosis, muscular sclerosis, Crohn's disease, UV exposure, burns, warts, dandruff, seborrheic dandruff, chronic inflammation, seborrhea, keratosis, alopecia, hirsutism, capitis, melanoma or non-melanoma skin cancer, basal cell cancer (BCC), squamous cell cancer (SCC), scleroderma, dermatofibrosarcoma protuberans, Merkel cell carcinoma, Kaposi's sarcoma, keratoacanthoma, spindle cell tumors, sebaceous carcinomas, microcystic adnexal carcinoma, Paget's disease of the breast, atypical fibroxanthoma, leiomyosarcoma, and angiosarcoma, Marjolin's ulcers, kidney failure, nerve damage caused by a skin condition, or skin burrowing mites, or a skin ailment, lesion or sore, particularly of the scalp and also for other skin regions affected by an ailment that is susceptible to topical or hair treatment, as well as hair fall or hair loss conditions, or combinations thereof. The method includes measuring an elevated and/or low level or combination of levels of one or more inflammatory cytokines, growth factors; cytokine receptors; ligand to surface markers, chemokines, protoangiogenic mediators, automicrobial proteins, neuropeptides, oxidative stress markers, dendritic cells (DC), plasmacytoid DC, monocytes, macrophages, histamines, T&B lymphocytes, or theranostic biomarkers, or combinations thereof, in a first bodily fluid or skin sample, or both, extracted from a patient. The method further includes formulating a diagnosis of scalp psoriasis, dermatitis, atopic dermatitis, eczema, herpes, shingles, rheumatoid arthritis (RA), arthritic psoriasis/psoriatic arthritis, Alzheimer's, Parkinson's, irritable bowel syndrome (IBS), colitis, prostitis, vasculitis, osteoarthritis, seborrheic dermatitis, acne, colitis, skin lesions, diabetes, hypertension, allergies, asthma, capuche sarcoma, autoimmune, inflammation, dermatologic, cardiovascular, metabolic syndrome, hypotension, coronary artery disease, depression, lupus, sarcoidosis, muscular sclerosis, Crohn's disease, UV exposure, burns, warts, dandruff, seborrheic dandruff, chronic inflammation, seborrhea, keratosis, alopecia, hirsutism, capitis, melanoma or non-melanoma skin cancer, basal cell cancer (BCC), squamous cell cancer (SCC), scleroderma, dermatofibrosarcoma protuberans, Merkel cell carcinoma, Kaposi's sarcoma, keratoacanthoma, spindle cell tumors, sebaceous carcinomas, microcystic adnexal carcinoma, Paget's disease of the breast, atypical fibroxanthoma, leiomyosarcoma, and angiosarcoma, Marjolin's ulcers, kidney failure, nerve damage caused by a skin condition, or skin burrowing mites, or a skin ailment, lesion or sore, particularly of the scalp and also for other skin regions affected by an ailment that is susceptible to topical or hair treatment, as well as hair fall or hair loss conditions, or combinations thereof, for the patient based on said measuring said elevated and/or low level or combination of levels. The method also includes administering a medicinal composition that comprises an effective dose between 1.0wt.%-15wt.% of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua to the patient.
A treatment method may also include measuring a reduced level or combination of levels of one or more inflammatory cytokines, growth factors; cytokine receptors; ligand to surface markers, chemokines, protoangiogenic mediators, automicrobial proteins, neuropeptides, oxidative stress markers, dendritic cells (DC), plasmacytoid DC, monocytes, macrophages, histamines, T&B lymphocytes, or theranostic biomarkers, or combinations thereof, in a second bodily fluid or skin sample, or both, extracted from the patient after administering said medicinal composition; and repeating the administering of said medicinal composition to said patient based on said measuring said reduced level or combination of levels.
A medicinal composition may include between 1.0wt.%-15wt.% of the herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua. The medicinal composition comprises 2.5wt.% or more of the herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua. The medicinal composition may include 10wt.% or less of the herbal combination of Da Huang, Sheng di Huang and Jin Yin Hua. The medicinal composition may include 2.5wt.%-5.0wt.% of the herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
A medicinal composition may include an effective dose between 1-6 grams of said herbal combination for a 50 kg patient or 2-12 grams for a 100 kg patient. The effective dose may include 0.2-1.2 grams of Da Huang, 0.6-3.6 grams of Sheng Di Huang and 0.2-1.2 grams of Jin Yin Hua for a 50 kg patient or 0.4-2.4 grams of Da Huang, 1.2-7.2 grams of Sheng Di Huang and 0.4-2.4 grams of Jin Yin Hua for a 100 kg patient.
A medicinal composition may be formulated as a shampoo and applied to the scalp. The medicinal composition may be formulated as a shampoo, conditioner, cream, lotion, ointment or other topical scalp or hair treatment. The medicinal composition may be formulated as a cream, lotion, ointment or other topical skin treatment.
A method may further include administering, in combination with said medicinal composition that comprises effective doses between 20-160 mg/kg of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua, one or more additional medicines comprising
Etanercept, Betamethotrexate, Methotrexate, 5-fluoroviacil, Paclitaxel, Adriamycin (doxorubicin), Etoposide, 5-fluorourasil, Docetaxil, Vincristine, Irinotecan, Methylprednisolone, Carboplatin, Dacarbazine, Acitretin, Glycyrrhizin, Paeonia lactiflora, Glycyrrhiza uralensis, Mahonia aquafolium, Aloe vera, Indigo naturalis, Kaku nut oil, Camptotheca acuminatanut, Calcipotriol and tazarotene gel, Otezla, Embrel, Humira, Cinzia, Cosentyx, Remicade, Simponi, Taltz, one or more steroids, Tacrolimus, Prograf, or cyclosporine, or combinations thereof.
A method may further include administering, in combination with said medicinal composition that comprises effective doses between 20-160 mg/kg of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua, one or more additional medicines comprising an inhibitor or enabler of a biologic, protein, molecule or receptor component of a patient, such as IL- 12, IL-23, TNF alpha, JAK, STAT, IL-17, PDE4, p40 subunit of IL-12 and/or IL-23 and/or a humanized p40 monoclonal antibody, IL-22, IL-20, IL-23/pl9, JAK3, TH0, Thl, Thl7 and/or Th22 cell, IFN alpha or IFN gamma, IL-15, IL-17R, IL-18, IL-19, IL-21, sPLA2, NO (nitric oxide), VEGF, IL-24, kinase, tyrosine, topoisomerase, IL-1, IL-2, IL-6, IL-8, BTK, SYK, ZAP- 70, PI3KCD, AKT, ALK, TRPV1, TRPA1, MRGPRA3, PAR2, mucunain or other proteases, chloroquine, pruritogen, cowhage, sapsaicin, HER-2, FLT-3, MAPK1, BRAF, MEK1, PD-1, CD279, PD-L1, LYN, ABL, FLT3, KIT, LCK, JAK1, PLC, BCR, P13K delta, TGF betal, GMCSF, MCP-1, AKT1 (PKB alpha), ERBB2 (HER2), FLT3, MAPKl (ERK2), PRKCA (PKC alpha), BRAF, BRAF V599E, MAP2K1 (MEK1), PGE2-PG4, PTGER4, PTGS2, or COX2, or combinations thereof. A medicine, medical kit, diagnostic kit, prognostic kit and method of preparing a medicine are each also accordingly provided.
A method may further include administering, in combination with said medicinal composition that comprises effective doses between 20-160 mg/kg of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua, one or more additional medicines comprising a dermal or epidermal inflammation, neutrophil, monocyte chemotaxis, antimicrobial defense mechanism, pruritus, acanthosis, parakeratosis, hyperkeratosis, angiogenesis.
A medicine is also provided for treating scalp psoriasis, dermatitis, atopic dermatitis, eczema, herpes, shingles, rheumatoid arthritis (RA), arthritic psoriasis/psoriatic arthritis,
Alzheimer's, Parkinson's, irritable bowel syndrome (IBS), colitis, prostitis, vasculitis,
osteoarthritis, seborrheic dermatitis, acne, colitis, skin lesions, diabetes, hypertension, allergies, asthma, capuche sarcoma, autoimmune, inflammation, dermatologic, cardiovascular, metabolic syndrome, hypotension, coronary artery disease, depression, lupus, sarcoidosis, muscular sclerosis, Crohn's disease, UV exposure, burns, warts, dandruff, seborrheic dandruff, chronic inflammation, seborrhea, keratosis, alopecia, hirsutism, capitis, melanoma or non-melanoma skin cancer, basal cell cancer (BCC), squamous cell cancer (SCC), scleroderma, dermatofibrosarcoma protuberans, Merkel cell carcinoma, Kaposi's sarcoma, keratoacanthoma, spindle cell tumors, sebaceous carcinomas, microcystic adnexal carcinoma, Paget's disease of the breast, atypical fibroxanthoma, leiomyosarcoma, and angiosarcoma, Marjolin's ulcers, kidney failure, nerve damage caused by a skin condition, or skin burrowing mites, or a skin ailment, lesion or sore, particularly of the scalp and also for other skin regions affected by an ailment that is susceptible to topical or hair treatment, as well as hair fall or hair loss conditions, or combinations thereof. The medicine includes a shampoo, conditioner, cream, lotion, ointment or other topical skin, scalp or hair treatment or a pill, skin patch, gel, injection pen, subdermal injection, IV fluid, tablet, capsule, lipid carrier, nano-crystal or other nano-particulate formulation, subcutaneous insert, or stent, or combinations thereof, that comprises a predetermined number of one or more effective doses, each effective dose including between 20-160 mg/kg of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
Effective doses of the medicine may include between 1-6 grams of said herbal
combination for a 50 kg patient or 2-12 grams for a 100 kg patient.
Effective doses of the medicine may include 0.2-1.2 grams of Da Huang, 0.6-3.6 grams of Sheng Di Huang and 0.2-1.2 grams of Jin Yin Hua for a 50 kg patient or 0.4-2.4 grams of Da Huang, 1.2-7.2 grams of Sheng Di Huang and 0.4-2.4 grams of Jin Yin Hua for a 100 kg patient.
Effective doses of the medicine may include 1.0wt.%-15.0wt.% of said herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
Effective doses of the medicine may include 2.5wt.%-5.0wt.% of said herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
Another medicine is provided for treating scalp psoriasis, dermatitis, atopic dermatitis, eczema, herpes, shingles, rheumatoid arthritis (RA), arthritic psoriasis/psoriatic arthritis,
Alzheimer's, Parkinson's, irritable bowel syndrome (IBS), colitis, prostitis, vasculitis,
osteoarthritis, seborrheic dermatitis, acne, colitis, skin lesions, diabetes, hypertension, allergies, asthma, capuche sarcoma, autoimmune, inflammation, dermatologic, cardiovascular, metabolic syndrome, hypotension, coronary artery disease, depression, lupus, sarcoidosis, muscular sclerosis, Crohn's disease, UV exposure, burns, warts, dandruff, seborrheic dandruff, chronic inflammation, seborrhea, keratosis, alopecia, hirsutism, capitis, melanoma or non-melanoma skin cancer, basal cell cancer (BCC), squamous cell cancer (SCC), scleroderma, dermatofibrosarcoma protuberans, Merkel cell carcinoma, Kaposi's sarcoma, keratoacanthoma, spindle cell tumors, sebaceous carcinomas, microcystic adnexal carcinoma, Paget's disease of the breast, atypical fibroxanthoma, leiomyosarcoma, and angiosarcoma, Marjolin's ulcers, kidney failure, nerve damage caused by a skin condition, or skin burrowing mites, or a skin ailment, lesion or sore, particularly of the scalp and also for other skin regions affected by an ailment that is susceptible to topical or hair treatment, as well as hair fall or hair loss conditions, or combinations thereof. The medicine includes a shampoo, conditioner, cream, lotion, ointment or other topical skin, scalp or hair treatment or a pill, skin patch, gel, injection pen, subdermal injection, IV fluid, tablet, capsule, lipid carrier, nano-crystal or other nano-particulate formulation, subcutaneous insert, or stent, or combinations thereof, that comprises a predetermined number of one or more effective doses, each effective dose comprising between 1.0wt.%-15.0wt.% of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua. Effective doses of the medicine may include 0.2-1.2 grams of Da Huang, 0.6-3.6 grams of Sheng Di Huang and 0.2-1.2 grams of Jin Yin Hua for a 50 kg patient or 0.4-2.4 grams of Da Huang, 1.2-7.2 grams of Sheng Di Huang and 0.4-2.4 grams of Jin Yin Hua for a 100 kg patient.
Effective doses of the medicine may include 1-6 grams of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua for a 50 kg patient or 2-12 grams for a 100 kg patient.
Effective doses of the medicine may include 2.5wt.%-5.0wt.% of said herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
A medical kit is provided that includes a diagnostic kit and a medicinal formulation. The diagnostic kit includes a test kit and an indicator. The test kit is configured for measuring a level or combination of levels of one or more inflammatory cytokines, growth factors; cytokine receptors; ligand to surface markers, chemokines, protoangiogenic mediators, automicrobial proteins, neuropeptides, oxidative stress markers, dendritic cells (DC), plasmacytoid DC, monocytes, macrophages, histamines, T&B lymphocytes, or theranostic biomarkers, or combinations thereof, in a bodily fluid or skin sample, or both, and said indicator for providing a diagnostic result based on said measured level or combinations of levels and on one or more expected correlations between said level or combination of levels and manifestation of one or more diseases including scalp psoriasis, dermatitis, atopic dermatitis, eczema, herpes, shingles, rheumatoid arthritis (RA), arthritic psoriasis/psoriatic arthritis, Alzheimer's, Parkinson's, irritable bowel syndrome (IBS), colitis, prostitis, vasculitis, osteoarthritis, seborrheic dermatitis, acne, colitis, skin lesions, diabetes, hypertension, allergies, asthma, capuche sarcoma, autoimmune, inflammation, dermatologic, cardiovascular, metabolic syndrome, hypotension, coronary artery disease, depression, lupus, sarcoidosis, muscular sclerosis, Crohn's disease, UV exposure, burns, warts, dandruff, seborrheic dandruff, chronic inflammation, seborrhea, keratosis, alopecia, hirsutism, capitis, melanoma or non-melanoma skin cancer, basal cell cancer (BCC), squamous cell cancer (SCC), scleroderma, dermatofibrosarcoma protuberans, Merkel cell carcinoma, Kaposi's sarcoma, keratoacanthoma, spindle cell tumors, sebaceous carcinomas, microcystic adnexal carcinoma, Paget's disease of the breast, atypical fibroxanthoma, leiomyosarcoma, and angiosarcoma, Marjolin's ulcers, kidney failure, nerve damage caused by a skin condition, or skin burrowing mites, or a skin ailment, lesion or sore, particularly of the scalp and also for other skin regions affected by an ailment that is susceptible to topical or hair treatment, as well as hair fall or hair loss conditions, or combinations thereof. The medicinal formulation includes a shampoo, conditioner, cream, lotion, ointment or other topical skin, scalp or hair treatment or a pill, skin patch, gel, injection pen, subdermal injection packet, IV fluid package, tablet, capsule, lipid carrier, nano-crystal or other nano-particulate formulation, subcutaneous insert, or stent, or combinations thereof. The medicinal formulation includes a predetermined number of one or more effective doses including between 20-160 mg/kg of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
The medical kit may further include a prognostic kit that includes a prognostic test kit and a prognostic indicator. The prognostic test kit may be configured for measuring a level or combination of levels of one or more inflammatory cytokines, growth factors; cytokine receptors; ligand to surface markers, chemokines, protoangiogenic mediators, automicrobial proteins, neuropeptides, oxidative stress markers, dendritic cells (DC), plasmacytoid DC, monocytes, macrophages, histamines, T&B lymphocytes, or theranostic biomarkers, or combinations thereof, in a second bodily fluid or skin sample, or both, after a prognostic period of treatment. The prognostic indicator may be configured for providing a prognostic result for the patient based on a comparison of said measured level or combination of levels in the first and second bodily fluid or skin sample, or both.
Another medical kit is provided that includes a diagnostic kit and a medicinal formulation. The diagnostic kit includes a test kit and an indicator. The test kit is configured for measuring a level or combination of levels of one or more inflammatory cytokines, growth factors; cytokine receptors; ligand to surface markers, chemokines, protoangiogenic mediators, automicrobial proteins, neuropeptides, oxidative stress markers, dendritic cells (DC), plasmacytoid DC, monocytes, macrophages, histamines, T&B lymphocytes, or theranostic biomarkers, or combinations thereof, in a bodily fluid or skin sample, or both, and said indicator for providing a diagnostic result based on said measured level or combinations of levels and on one or more expected correlations between said level or combination of levels and manifestation of one or more diseases including scalp psoriasis, dermatitis, atopic dermatitis, eczema, herpes, shingles, rheumatoid arthritis (RA), arthritic psoriasis/psoriatic arthritis, Alzheimer's, Parkinson's, irritable bowel syndrome (IBS), colitis, prostitis, vasculitis, osteoarthritis, seborrheic dermatitis, acne, colitis, skin lesions, diabetes, hypertension, allergies, asthma, capuche sarcoma, autoimmune, inflammation, dermatologic, cardiovascular, metabolic syndrome, hypotension, coronary artery disease, depression, lupus, sarcoidosis, muscular sclerosis, Crohn's disease, UV exposure, burns, warts, dandruff, seborrheic dandruff, chronic inflammation, seborrhea, keratosis, alopecia, hirsutism, capitis, melanoma or non-melanoma skin cancer, basal cell cancer (BCC), squamous cell cancer (SCC), scleroderma, dermatofibrosarcoma protuberans, Merkel cell carcinoma, Kaposi's sarcoma, keratoacanthoma, spindle cell tumors, sebaceous carcinomas, microcystic adnexal carcinoma, Paget's disease of the breast, atypical fibroxanthoma, leiomyosarcoma, and angiosarcoma, Marjolin's ulcers, kidney failure, nerve damage caused by a skin condition, or skin burrowing mites, or a skin ailment, lesion or sore, particularly of the scalp and also for other skin regions affected by an ailment that is susceptible to topical or hair treatment, as well as hair fall or hair loss conditions, or combinations thereof. The medicinal formulation includes a shampoo, conditioner, cream, lotion, ointment or other topical skin, scalp or hair treatment or a pill, skin patch, gel, injection pen, subdermal injection packet, IV fluid package, tablet, capsule, lipid carrier, nano-crystal or other nano-particulate formulation, subcutaneous insert, or stent, or combinations thereof. The medicinal formulation includes a predetermined number of one or more effective doses between 1.0wt.%-15.0wt.% of an herbal combination of Da Huang, Sheng di Huang and Jin Yin Hua.
The medical kit may also include a prognostic kit including a prognostic test kit and a prognostic indicator. The prognostic test kit may be configured for measuring a level or combination of levels of one or more inflammatory cytokines, growth factors; cytokine receptors; ligand to surface markers, chemokines, protoangiogenic mediators, automicrobial proteins, neuropeptides, oxidative stress markers, dendritic cells (DC), plasmacytoid DC, monocytes, macrophages, histamines, T&B lymphocytes, or theranostic biomarkers, or combinations thereof, in a second bodily fluid or skin sample, or both, after a prognostic period of treatment. The prognostic indicator may be configured for providing a prognostic result for the patient based on a comparison of said measured level or combination of levels in the first and second bodily fluid or skin sample, or both.
Effective doses of the medicinal formulation may include 0.2-1.2 grams of Da Huang, 0.6-
3.6 grams of Sheng Di Huang and 0.2-1.2 grams of Jin Yin Hua for a 50 kg patient or 0.4-2.4 grams of Da Huang, 1.2-7.2 grams of Sheng Di Huang and 0.4-2.4 grams of Jin Yin Hua for a 100 kg patient.
Effective doses of the medicinal formulation may include 1-6 grams of said herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua for a 50 kg patient or 2-12 grams for a 100 kg patient.
Effective doses of the medicinal formulation may include 2.5wt.%-5.0wt.% of said herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
Effective doses of the medicinal formulation may include between 20-160 mg/kg of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
Effective doses of the medicinal formulation may include between 20-160 mg/kg of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
A prognostic kit is also provided that includes a medicinal formulation, and a prognostic test kit and indicator. The medicinal formulation includes shampoo, conditioner, cream, lotion, ointment or other topical skin, scalp or hair treatment or a pill, skin patch, gel, injection pen, subdermal injection packet, IV fluid package, tablet, capsule, lipid carrier, nano-crystal or other nano-particulate formulation, subcutaneous insert, or stent, or combinations thereof. The medicinal formulation includes a predetermined number of one or more effective doses between 20-160 mg/kg of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua. The prognostic test kit is configured for measuring a level or combination of levels of one or more inflammatory cytokines, growth factors; cytokine receptors; ligand to surface markers, chemokines, protoangiogenic mediators, automicrobial proteins, neuropeptides, oxidative stress markers, dendritic cells (DC), plasmacytoid DC, monocytes, macrophages, histamines, T&B lymphocytes, or theranostic biomarkers, or combinations thereof, in first and second bodily fluid or skin samples, or both, respectively extracted from a patient before and after a prognostic period of treatment with the medicinal formulation. The prognostic indicator is configured for providing a prognostic result for the patient based on a comparison of the measured level or combination of levels in the first and second bodily fluid or skin samples, or both.
Effective doses of the medicinal formulation may include 1.0wt.%-15.0wt.% of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
Effective doses of the medicinal formulation may include 2.5wt.%-5.0wt.% of the herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
Another prognostic kit is provided. The prognostic kit includes a shampoo, conditioner, cream, lotion, ointment or other topical skin, scalp or hair treatment or a pill, skin patch, gel, injection pen, subdermal injection, IV fluid, tablet, capsule, lipid carrier, nano-crystal or other nano-particulate formulation, subcutaneous insert, or stent, or combinations thereof, that comprises a predetermined number of one or more effective doses each including between 1.0wt.%-15.0wt.% of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua. The prognostic kit includes a prognostic test kit configured for measuring a level or combination of levels of one or more inflammatory cytokines, growth factors; cytokine receptors; ligand to surface markers, chemokines, protoangiogenic mediators, automicrobial proteins, neuropeptides, oxidative stress markers, dendritic cells (DC), plasmacytoid DC, monocytes, macrophages, histamines, T&B lymphocytes, or theranostic biomarkers, or combinations thereof, in first and second bodily fluid or skin samples, or both, respectively extracted from a patient before and after a prognostic period of treatment with said medicinal formulation, and a prognostic indicator configured for providing a prognostic result for the patient based on a comparison of measured levels or combinations of levels from said first and second bodily fluid or skin samples, or both. Effective doses of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua may include 0.2-1.2 grams of Da Huang, 0.6-3.6 grams of Sheng Di Huang and 0.2-1.2 grams of Jin Yin Hua for a 50 kg patient or 0.4-2.4 grams of Da Huang, 1.2-7.2 grams of Sheng Di Huang and 0.4-2.4 grams of Jin Yin Hua for a 100 kg patient.
Effective doses of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua may include 1-6 grams of the herbal combination for a 50 kg patient or 2-12 grams for a 100 kg patient.
Effective doses may include 2.5wt.%-5.0wt.% of the herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
Effective doses may include between 20-160 mg/kg of an herbal combination of Da
Huang, Sheng Di Huang and Jin Yin Hua.
Another method is provided for treating scalp psoriasis, dermatitis, atopic dermatitis, eczema, herpes, shingles, rheumatoid arthritis (RA), arthritic psoriasis/psoriatic arthritis,
Alzheimer's, Parkinson's, irritable bowel syndrome (IBS), colitis, prostitis, vasculitis,
osteoarthritis, seborrheic dermatitis, acne, colitis, skin lesions, diabetes, hypertension, allergies, asthma, capuche sarcoma, autoimmune, inflammation, dermatologic, cardiovascular, metabolic syndrome, hypotension, coronary artery disease, depression, lupus, sarcoidosis, muscular sclerosis, Crohn's disease, UV exposure, burns, warts, dandruff, seborrheic dandruff, chronic inflammation, seborrhea, keratosis, alopecia, hirsutism, capitis, melanoma or non-melanoma skin cancer, basal cell cancer (BCC), squamous cell cancer (SCC), scleroderma, dermatofibrosarcoma protuberans, Merkel cell carcinoma, Kaposi's sarcoma, keratoacanthoma, spindle cell tumors, sebaceous carcinomas, microcystic adnexal carcinoma, Paget's disease of the breast, atypical fibroxanthoma, leiomyosarcoma, and angiosarcoma, Marjolin's ulcers, kidney failure, nerve damage caused by a skin condition, or skin burrowing mites, or a skin ailment, lesion or sore, particularly of the scalp and also for other skin regions affected by an ailment that is susceptible to topical or hair treatment, as well as hair fall or hair loss conditions, or combinations thereof. The method includes measuring a level or combination of levels of one or more of IL-5, IL-13, IL-17, IL-23, TNF-a, IL-6, IL-7, IL-13, GMCSF, MCP-1, IL-1-β, IL-l-RA, IL-8, IL-9, IL-10, IL-12, IL- 4, IL-19, IL-20, IL-21, IL-22, IL-24, IL-25, IL-26, IL-31, IL-33, IL-17A, IL-17F, eotaxin, FGF-β, G-CSF, IFN-γ, IP-10, sCD40L, MIP-1, PDGFRB, MIP-1-β, RANTES, VEGF, JAK, JAKl, JAK3, MPO (myeloperoxidase), p38kinase, BRAF, BRAF V599E, KRAS, EGFR, ALK, TRPV1, TRPA1, MRGPRA3, PAR2, mucunain or other proteases, chloroquine, pruritogen, cowhage, sapsaicin, ROS, RET. SK-Mel-2, HT-29, MCF-7, THP-1, DU-145, MOLT-4, THP-1, K562, HL- 60, U937, PD-1, ICAM-1, VCAM-1, E-selectin, HACAT-THP-1, LYN, ABL, BTK, SYK, ZAP- 70, PI3KCD, AKT, HER-2, FLT-3, KIT, LCK, MAPK1, MEK1, PGE, MMP, PI3K-5, PIK3CD, PIK3R1 CCL3, CCL4, PLC, BCR, CD-5, CD-38, CD-19, CD-20, CD-79a, β2Μ, NO, LTB4, PLA2, or PDE4, OR A KINASE, E.G., AKTl (PKB ALPHA), ERBB2 (HER2), FLT3, MAPKl (ERK2), PRKCA (PKC ALPHA), BRAF, BRAF V599E OR MAP2K1 (MEK1), or combinations thereof, in a first bodily fluid or skin sample, or both, extracted from a patient. The method also includes formulating a diagnosis of scalp psoriasis, dermatitis, atopic dermatitis, eczema, herpes, shingles, rheumatoid arthritis (RA), arthritic psoriasis/psoriatic arthritis, Alzheimer's, Parkinson's, irritable bowel syndrome (IBS), colitis, prostitis, vasculitis, osteoarthritis, seborrheic dermatitis, acne, colitis, skin lesions, diabetes, hypertension, allergies, asthma, capuche sarcoma,
autoimmune, inflammation, dermatologic, cardiovascular, metabolic syndrome, hypotension, coronary artery disease, depression, lupus, sarcoidosis, muscular sclerosis, Crohn's disease, UV exposure, burns, warts, dandruff, seborrheic dandruff, chronic inflammation, seborrhea, keratosis, alopecia, hirsutism, capitis, melanoma or non-melanoma skin cancer, basal cell cancer (BCC), squamous cell cancer (SCC), scleroderma, dermatofibrosarcoma protuberans, Merkel cell carcinoma, Kaposi's sarcoma, keratoacanthoma, spindle cell tumors, sebaceous carcinomas, microcystic adnexal carcinoma, Paget's disease of the breast, atypical fibroxanthoma,
leiomyosarcoma, and angiosarcoma, Marjolin's ulcers, kidney failure, nerve damage caused by a skin condition, or skin burrowing mites, or a skin ailment, lesion or sore, particularly of the scalp and also for other skin regions affected by an ailment that is susceptible to topical or hair treatment, as well as hair fall or hair loss conditions, or combinations thereof, for the patient based on said measured level or combination of levels and on one or more expected correlations between said level or combination of levels and manifestation within said patient of one or more diseases. The method also includes administering a medicinal composition that comprises an effective dose between 20-160 mg/kg of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua to the patient to treat the patient in accordance with said diagnosis.
The method may include measuring a level or combination of levels of one or more of IL- 5, IL-13, IL-17, IL-23, TNF-a, IL-6, IL-7, IL-13, IL-15, GM-CSF, MCP-1, MCP-l(MCAF), IL-1- β, IL-l-RA, IL-8, IL-9, IL-10, IL-12, IL-12(p70), IL-19, IL-20, IL-22, IL-24, IL-26, IL-lra, IL-2, eotaxin, FGF basic, FGF-β, G-CSF, IFN-γ, IP- 10, MIP-1, PDGFRB, MIP-1-α, MIP-1-β,
RANTES, VEGF, JAK, JAKl, JAK3, MPO (myeloperoxidase), p38kinase, BRAF, BRAF V599E, KRAS, EGFR, ALK, TRPV1, TRPA1, MRGPRA3, PAR2, mucunain or other proteases, chloroquine, pruritogen, cowhage, sapsaicin, ROS, RET. SK-Mel-2, HT-29, MCF-7, THP-1, DU- 145, MOLT-4, THP-1, K562, HL-60, U937, PD-1, ICAM-1, VCAM-1, E-selectin, HACAT-THP- 1, LYN, ABL, BTK, SYK, ZAP-70, PI3KCD, AKT, HER-2, FLT-3, KIT, LCK, MAPKl, MEK1, PGE, MMP, PI3K-5, PIK3CD, PIK3R1 CCL3, CCL4, PLC, BCR, CD-5, CD-38, CD-19, CD-20, CD-79a, β2Μ, NO, LTB4, PLA2, or PDE4, OR A KINASE, E.G., AKTl (PKB ALPHA), ERBB2 (HER2), FLT3, MAPKl (ERK2), PRKCA (PKC ALPHA), BRAF, BRAF V599E OR MAP2K1 (MEKl), or combinations thereof, in a second bodily fluid or skin sample, or both, extracted from the patient after administering said medicinal composition over a prognostic period; and indicating to repeat the administering of the medicinal composition that comprises an effective dose between 20-160 mg/kg of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua to said patient a significant number of further times based on a comparison between said measured levels or combinations of levels within said first and second bodily fluid or skin samples, or both, and on an expected correlation between certain differences between measured levels or combinations of levels in bodily fluid samples respectively extracted before and after a prognostic period of administration of said medicinal composition.
The medicinal composition may include between 1.0wt.%-15wt.% of said herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua. The medicinal composition may include 2.5wt.% or more of said herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua. The medicinal composition may include 10wt.% or less of said herbal combination of Da Huang, Sheng di Huang and Jin Yin Hua.
The medicinal composition may include 2.5wt.%-5.0wt.% of said herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
The medicinal composition may include an effective dose between 1-6 grams of said herbal combination for a 50 kg patient or 2-12 grams for a 100 kg patient. Effective doses may include 0.2-1.2 grams of Da Huang, 0.6-3.6 grams of Sheng Di Huang and 0.2-1.2 grams of Jin Yin Hua for a 50 kg patient or 0.4-2.4 grams of Da Huang, 1.2-7.2 grams of Sheng Di Huang and 0.4-2.4 grams of Jin Yin Hua for a 100 kg patient.
The medicinal composition may be formulated as a shampoo and applied to the scalp.
The medicinal composition may be formulated as a shampoo, conditioner, cream, lotion, ointment or other topical scalp or hair treatment.
The medicinal composition may be formulated as a cream, lotion, ointment or other topical skin treatment.
The may further include administering, in combination with said medicinal composition that comprises effective doses between 20-160 mg/kg of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua, one or more additional medicines including Etanercept, Betamethotrexate, Methotrexate, 5-fluoroviacil, Paclitaxel, Adriamycin (doxorubicin), Etoposide, 5-fluorourasil, Docetaxil, Vincristine, Irinotecan, Methylprednisolone, Carboplatin, Dacarbazine, Acitretin, Glycyrrhizin, Paeonia lactiflora, Glycyrrhiza uralensis, Mahonia aquafolium, Aloe vera, Indigo naturalis, Kaku nut oil, Camptotheca acuminatanut, Calcipotriol and tazarotene gel, Otezla, Embrel, Humira, Cinzia, Cosentyx, Remicade, Simponi, Taltz, one or more steroids, Tacrolimus, Prograf, or cyclosporine, or combinations thereof.
The method may further include administering, in combination with said medicinal composition that comprises effective doses between 20-160 mg/kg of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua, one or more additional medicines including an IL-12, IL-23, TNF alpha, JAK, STAT, IL-17, PDE4, p40 subunit of IL-12 and/or IL-23 and/or a humanized p40 monoclonal antibody, IL-22, IL-20, IL-23/pl9, JAK3, Thl, Thl7 and/or Th22 cell, IFN gamma, IL-17R, IL-19, sPLA2, NO (nitric oxide), VEGF, IL-24, kinase, tyrosine, topoisomerase, IL-1, IL-6, IL-8, BTK, SYK, ZAP-70, PI3KCD, AKT, HER-2, FLT-3, MAPKl, BRAF, MEK1, PD-1, CD279, PD-L1, LYN, ABL, FLT3, KIT, LCK, JAKl, PLC, BCR, P13K delta, GMCSF, MCP-1, AKTl (PKB alpha), ERBB2 (HER2), FLT3, MAPKl (ERK2), PRKCA (PKC alpha), BRAF, BRAF V599E or MAP2K1 (MEK1) inhibitor, or combinations thereof.
Another method is provided for treating scalp psoriasis, dermatitis, atopic dermatitis, eczema, herpes, shingles, rheumatoid arthritis (RA), arthritic psoriasis/psoriatic arthritis,
Alzheimer's, Parkinson's, irritable bowel syndrome (IBS), colitis, prostitis, vasculitis,
osteoarthritis, seborrheic dermatitis, acne, colitis, skin lesions, diabetes, hypertension, allergies, asthma, capuche sarcoma, autoimmune, inflammation, dermatologic, cardiovascular, metabolic syndrome, hypotension, coronary artery disease, depression, lupus, sarcoidosis, muscular sclerosis, Crohn's disease, UV exposure, burns, warts, dandruff, seborrheic dandruff, chronic inflammation, seborrhea, keratosis, alopecia, hirsutism, capitis, melanoma or non-melanoma skin cancer, basal cell cancer (BCC), squamous cell cancer (SCC), scleroderma, dermatofibrosarcoma protuberans, Merkel cell carcinoma, Kaposi's sarcoma, keratoacanthoma, spindle cell tumors, sebaceous carcinomas, microcystic adnexal carcinoma, Paget's disease of the breast, atypical fibroxanthoma, leiomyosarcoma, and angiosarcoma, Marjolin's ulcers, kidney failure, nerve damage caused by a skin condition, or skin burrowing mites, or a skin ailment, lesion or sore, particularly of the scalp and also for other skin regions affected by an ailment that is susceptible to topical or hair treatment, as well as hair fall or hair loss conditions, or combinations thereof. The method includes measuring a level or combination of levels of one or more of IL-5, IL-13, IL-17, IL-23, TNF-a, IL-6, IL-7, IL-13, GMCSF, MCP-1, IL-1-β, IL-l-RA, IL-8, IL-9, IL-10, IL-12, IL- 19, IL-20, IL-22, IL-24, IL-26, eotaxin, FGF-β, G-CSF, IFN-γ, IP- 10, MIP-1, PDGF-RB, PDGF- BB, MIP-1-β, RANTES, VEGF, JAK, JAKl, JAK3, MPO (myeloperoxidase), p38kinase, BRAF, BRAF V599E, KRAS, EGFR, ALK, TRPV1, TRPA1, MRGPRA3, PAR2, mucunain or other proteases, chloroquine, pruritogen, cowhage, sapsaicin, ROS, RET. SK-Mel-2, HT-29, MCF-7, THP-1, DU-145, MOLT-4, THP-1, K562, HL-60, U937, PD-1, ICAM-1, VCAM-1, E-selectin, HACAT-THP-1, LYN, ABL, BTK, SYK, ZAP-70, PI3KCD, AKT, HER-2, FLT-3, KIT, LCK, MAPK1, MEK1, PGE, MMP, PI3K-5, PIK3CD, PIK3R1 CCL3, CCL4, PLC, BCR, CD-5, CD- 38, CD-19, CD-20, CD-79a, β2Μ, NO, LTB4, PLA2, or PDE4, OR A KINASE, E.G., AKTl (PKB ALPHA), ERBB2 (HER2), FLT3, MAPKl (ERK2), PRKCA (PKC ALPHA), BRAF, BRAF V599E OR MAP2K1 (MEK1), or combinations thereof, in a first bodily fluid, or skin sample, or both, or serum or sera, extracted from a patient. The method also includes formulating a diagnosis of scalp psoriasis, dermatitis, atopic dermatitis, eczema, herpes, shingles, rheumatoid arthritis (RA), arthritic psoriasis/psoriatic arthritis, Alzheimer's, Parkinson's, irritable bowel syndrome (IBS), colitis, prostitis, vasculitis, osteoarthritis, seborrheic dermatitis, acne, colitis, skin lesions, diabetes, hypertension, allergies, asthma, capuche sarcoma, autoimmune, inflammation, dermatologic, cardiovascular, metabolic syndrome, hypotension, coronary artery disease, depression, lupus, sarcoidosis, muscular sclerosis, Crohn's disease, UV exposure, burns, warts, dandruff, seborrheic dandruff, chronic inflammation, seborrhea, keratosis, alopecia, hirsutism, capitis, melanoma or non-melanoma skin cancer, basal cell cancer (BCC), squamous cell cancer (SCC), scleroderma, dermatofibrosarcoma protuberans, Merkel cell carcinoma, Kaposi's sarcoma, keratoacanthoma, spindle cell tumors, sebaceous carcinomas, microcystic adnexal carcinoma, Paget's disease of the breast, atypical fibroxanthoma, leiomyosarcoma, and angiosarcoma, Marjolin's ulcers, kidney failure, nerve damage caused by a skin condition, or skin burrowing mites, or a skin ailment, lesion or sore, particularly of the scalp and also for other skin regions affected by an ailment that is susceptible to topical or hair treatment, as well as hair fall or hair loss conditions, or combinations thereof, for the patient based on said measured level or combination of levels and on one or more expected correlations between said level or combination of levels and manifestation within said patient of one or more diseases. The method also includes administering a medicinal composition that comprises an effective dose between 1.0wt.%-15wt.% of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua for a 50 kg patient or 2- 12 grams for a 100 kg patient to treat the patient in accordance with said diagnosis.
The method may also include measuring a level or combination of levels of one or more of IL-5, IL-13, IL-17, IL-23, TNF-a, IL-6, IL-7, IL-13, GMCSF, MCP-1, IL-1-β, IL-l-RA, IL-8, IL- 9, IL-10, IL-12, IL-19, IL-20, IL-22, IL-24, IL-26, eotaxin, FGF-β, G-CSF, IFN-γ, IP-10, MIP-1, PDGFRB, MIP-1 -β, RANTES, VEGF, JAK, JAKl, JAK3, MPO (myeloperoxidase), p38kinase, BRAF, BRAF V599E, KRAS, EGFR, ALK, TRPV1, TRPA1, MRGPRA3, PAR2, mucunain or other proteases, chloroquine, pruritogen, cowhage, sapsaicin, ROS, RET. SK-Mel-2, HT-29, MCF-7, THP-1, DU-145, MOLT-4, THP-1, K562, HL-60, U937, PD-1, ICAM-1, VCAM-1, E- selectin, HACAT-THP-1, LYN, ABL, BTK, SYK, ZAP-70, PI3KCD, AKT, HER-2, FLT-3, KIT, LCK, MAPKl, MEK1, PGE, MMP, PI3K-5, PIK3CD, PIK3R1 CCL3, CCL4, PLC, BCR, CD-5, CD-38, CD-19, CD-20, CD-79a, β2Μ, NO, LTB4, PLA2, or PDE4, OR A KINASE, E.G., AKTl (PKB ALPHA), ERBB2 (HER2), FLT3, MAPKl (ERK2), PRKCA (PKC ALPHA), BRAF, BRAF V599E OR MAP2K1 (MEK1), or combinations thereof, in a second bodily fluid or skin sample, or both, extracted from the patient after administering said medicinal composition over a prognostic period; and indicating to repeat the administering of effective doses of said medicinal composition to said patient a significant number of further times based on a comparison between said measured levels or combinations of levels within said first and second bodily fluid or skin samples, or both, and on an expected correlation between certain differences between said measured levels or combinations of levels in bodily fluid samples respectively extracted before and after the prognostic period of administration of said medicinal composition.
The medicinal composition may include between 1-6 grams of said herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua for a 50 kg patient or 2-12 grams for a 100 kg patient.
The medicinal composition may include 2.5wt.% or more of said herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua. The medicinal composition may include 10wt.% or less of said herbal combination of Da Huang, Sheng di Huang and Jin Yin Hua.
The medicinal composition may include 2.5wt.%-5.0wt.% of said herbal combination of
Da Huang, Sheng Di Huang and Jin Yin Hua.
Effective doses may include 0.2-1.2 grams of Da Huang, 0.6-3.6 grams of Sheng Di Huang and 0.2-1.2 grams of Jin Yin Hua for a 50 kg patient or 0.4-2.4 grams of Da Huang, 1.2-7.2 grams of Sheng Di Huang and 0.4-2.4 grams of Jin Yin Hua for a 100 kg patient.
The medicinal composition may be formulated as a shampoo and applied to the scalp.
The medicinal composition may be formulated as a shampoo, conditioner, cream, lotion, ointment or other topical scalp or hair treatment.
The medicinal composition may be formulated as a cream, lotion, ointment or other topical skin treatment.
The method may further include administering, in combination with said medicinal composition that comprises effective doses between 1.0wt.%-15wt.% of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua, one or more additional medicines including
Etanercept, Betamethotrexate, Methotrexate, 5-fluoroviacil, Paclitaxel, Adriamycin (doxorubicin), Etoposide, 5-fluorourasil, Docetaxil, Vincristine, Irinotecan, Methylprednisolone, Carboplatin, Dacarbazine, Acitretin, Glycyrrhizin, Paeonia lactiflora, Glycyrrhiza uralensis, Mahonia aquafolium, Aloe vera, Indigo naturalis, Kaku nut oil, Camptotheca acuminatanut, Calcipotriol and tazarotene gel, Otezla, Embrel, Humira, Cinzia, Cosentyx, Remicade, Simponi, Taltz, one or more steroids, Tacrolimus, Prograf, or cyclosporine, or combinations thereof.
The method may further include administering, in combination with said medicinal composition that comprises effective doses between 1.0wt.%-15wt.% of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua, one or more additional medicines including an IL- 12, IL-23, TNF alpha, JAK, STAT, IL-17, PDE4, p40 subunit of IL-12 and/or IL-23 and/or a humanized p40 monoclonal antibody, IL-22, IL-20, IL-23/pl9, JAK3, Thl, Thl7 and/or Th22 cell, IFN gamma, IL-17R, IL-19, sPLA2, NO (nitric oxide), VEGF, IL-24, kinase, tyrosine, topoisomerase, IL-1, IL-6, IL-8, BTK, SYK, ZAP-70, PI3KCD, AKT, HER-2, FLT-3, MAPKl, BRAF, MEK1, PD-1, CD279, PD-L1, LYN, ABL, FLT3, KIT, LCK, JAK1, PLC, BCR, P13K delta, GMCSF, MCP-1, AKT1 (PKB alpha), ERBB2 (HER2), FLT3, MAPKl (ERK2), PRKCA (PKC alpha), BRAF, BRAF V599E or MAP2K1 (MEK1) inhibitor, or combinations thereof.
Another medicine is provided for treating scalp psoriasis, dermatitis, atopic dermatitis, eczema, herpes, shingles, rheumatoid arthritis (RA), arthritic psoriasis/psoriatic arthritis,
Alzheimer's, Parkinson's, irritable bowel syndrome (IBS), colitis, prostitis, vasculitis,
osteoarthritis, seborrheic dermatitis, acne, colitis, skin lesions, diabetes, hypertension, allergies, asthma, capuche sarcoma, autoimmune, inflammation, dermatologic, cardiovascular, metabolic syndrome, hypotension, coronary artery disease, depression, lupus, sarcoidosis, muscular sclerosis, Crohn's disease, UV exposure, burns, warts, dandruff, seborrheic dandruff, chronic inflammation, seborrhea, keratosis, alopecia, hirsutism, capitis, melanoma or non-melanoma skin cancer, basal cell cancer (BCC), squamous cell cancer (SCC), scleroderma, dermatofibrosarcoma protuberans, Merkel cell carcinoma, Kaposi's sarcoma, keratoacanthoma, spindle cell tumors, sebaceous carcinomas, microcystic adnexal carcinoma, Paget's disease of the breast, atypical fibroxanthoma, leiomyosarcoma, and angiosarcoma, Marjolin's ulcers, kidney failure, nerve damage caused by a skin condition, or skin burrowing mites, or a skin ailment, lesion or sore, particularly of the scalp and also for other skin regions affected by an ailment that is susceptible to topical or hair treatment, as well as hair fall or hair loss conditions, or combinations thereof. The medicine includes a shampoo, conditioner, cream, lotion, ointment or other topical skin, scalp or hair treatment or a pill, skin patch, gel, injection pen, subdermal injection, IV fluid, tablet, capsule, lipid carrier, nano-crystal or other nano-particulate formulation, subcutaneous insert, or stent, or combinations thereof, that comprises a predetermined number of one or more effective doses, each effective dose including between 20-160 mg/kg of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
Effective doses may include between 1-6 grams of said herbal combination for a 50 kg patient or 2-12 grams for a 100 kg patient. Effective doses may include 0.2-1.2 grams of Da Huang, 0.6-3.6 grams of Sheng Di Huang and 0.2-1.2 grams of Jin Yin Hua for a 50 kg patient or 0.4-2.4 grams of Da Huang, 1.2-7.2 grams of Sheng Di Huang and 0.4-2.4 grams of Jin Yin Hua for a 100 kg patient.
Effective doses may include 1.0wt.%-15.0wt.% of said herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
Effective doses may include 2.5wt.%-5.0wt.% of said herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
Another medicine is provided for treating scalp psoriasis, dermatitis, atopic dermatitis, eczema, herpes, shingles, rheumatoid arthritis (RA), arthritic psoriasis/psoriatic arthritis,
Alzheimer's, Parkinson's, irritable bowel syndrome (IBS), colitis, prostitis, vasculitis,
osteoarthritis, seborrheic dermatitis, acne, colitis, skin lesions, diabetes, hypertension, allergies, asthma, capuche sarcoma, autoimmune, inflammation, dermatologic, cardiovascular, metabolic syndrome, hypotension, coronary artery disease, depression, lupus, sarcoidosis, muscular sclerosis, Crohn's disease, UV exposure, burns, warts, dandruff, seborrheic dandruff, chronic inflammation, seborrhea, keratosis, alopecia, hirsutism, capitis, melanoma or non-melanoma skin cancer, basal cell cancer (BCC), squamous cell cancer (SCC), scleroderma, dermatofibrosarcoma protuberans, Merkel cell carcinoma, Kaposi's sarcoma, keratoacanthoma, spindle cell tumors, sebaceous carcinomas, microcystic adnexal carcinoma, Paget's disease of the breast, atypical fibroxanthoma, leiomyosarcoma, and angiosarcoma, Marjolin's ulcers, kidney failure, nerve damage caused by a skin condition, or skin burrowing mites, or a skin ailment, lesion or sore, particularly of the scalp and also for other skin regions affected by an ailment that is susceptible to topical or hair treatment, as well as hair fall or hair loss conditions, or combinations thereof. The medicine includes a shampoo, conditioner, cream, lotion, ointment or other topical skin, scalp or hair treatment or a pill, skin patch, gel, injection pen, subdermal injection, IV fluid, tablet, capsule, lipid carrier, nano-crystal or other nano-particulate formulation, subcutaneous insert, or stent, or combinations thereof, that includes a predetermined number of one or more effective doses, each effective dose including between 1.0wt.%-15.0wt.% of said herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua. Effective doses may include 0.2-1.2 grams of Da Huang, 0.6-3.6 grams of Sheng Di Huang and 0.2-1.2 grams of Jin Yin Hua for a 50 kg patient or 0.4-2.4 grams of Da Huang, 1.2-7.2 grams of Sheng Di Huang and 0.4-2.4 grams of Jin Yin Hua for a 100 kg patient.
Effective doses may include 1-6 grams of said herbal combination for a 50 kg patient or 2- 12 grams for a 100 kg patient.
Effective doses may include 2.5wt.%-5.0wt.% of said herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
A medical kit is providing including a diagnostic kit and a medicinal formulation. The diagnostic kit includes a test kit and an indicator. The test kit is configured for measuring a level or combination of levels of one or more of IL-5, IL-13, IL-17, IL-23, TNF-a, IL-6, IL-7, IL-13, GMCSF, MCP-1, IL-9, IL-1-β, IL-l-RA, IL-8, IL-10, IL-12, IL-19, IL-20, IL-22, IL-24, IL-26, eotaxin, FGF-β, G-CSF, IFN-γ, IP- 10, MIP-1, PDGFRB, MIP-1 -β, RANTES, VEGF, JAK, JAKl, JAK3, MPO (myeloperoxidase), p38kinase, BRAF, BRAF V599E, KRAS, EGFR, ALK, TRPVl, TRPA1, MRGPRA3, PAR2, mucunain or other proteases, chloroquine, pruritogen, cowhage, sapsaicin, ROS, RET. SK-Mel-2, HT-29, MCF-7, THP-1, DU-145, MOLT-4, THP-1, K562, HL- 60, U937, PD-1, ICAM-1, VCAM-1, E-selectin, HACAT-THP-1, LYN, ABL, BTK, SYK, ZAP- 70, PI3KCD, AKT, HER-2, FLT-3, KIT, LCK, MAPKl, MEKl, PGE, MMP, PI3K-5, PIK3CD, PIK3R1 CCL3, CCL4, PLC, BCR, CD-5, CD-38, CD-19, CD-20, CD-79a, β2Μ, NO, LTB4, PLA2, or PDE4, OR A KINASE, E.G., AKT1 (PKB ALPHA), ERBB2 (HER2), FLT3, MAPKl (ERK2), PRKCA (PKC ALPHA), BRAF, BRAF V599E OR MAP2K1 (MEKl), or combinations thereof, in a bodily fluid or skin sample, or both. The indicator is configured for providing a diagnostic result based on said measured level or combinations of levels and on one or more expected correlations between said level or combination of levels and manifestation of one or more diseases including scalp psoriasis, dermatitis, atopic dermatitis, eczema, herpes, shingles, rheumatoid arthritis (RA), arthritic psoriasis/psoriatic arthritis, Alzheimer's, Parkinson's, irritable bowel syndrome (IBS), colitis, prostitis, vasculitis, osteoarthritis, seborrheic dermatitis, acne, colitis, skin lesions, diabetes, hypertension, allergies, asthma, capuche sarcoma, autoimmune, inflammation, dermatologic, cardiovascular, metabolic syndrome, hypotension, coronary artery disease, depression, lupus, sarcoidosis, muscular sclerosis, Crohn's disease, UV exposure, burns, warts, dandruff, seborrheic dandruff, chronic inflammation, seborrhea, keratosis, alopecia, hirsutism, capitis, melanoma or non-melanoma skin cancer, basal cell cancer (BCC), squamous cell cancer (SCC), scleroderma, dermatofibrosarcoma protuberans, Merkel cell carcinoma, Kaposi's sarcoma, keratoacanthoma, spindle cell tumors, sebaceous carcinomas, microcystic adnexal carcinoma, Paget's disease of the breast, atypical fibroxanthoma, leiomyosarcoma, and angiosarcoma, Marjolin's ulcers, kidney failure, nerve damage caused by a skin condition, or skin burrowing mites, or a skin ailment, lesion or sore, particularly of the scalp and also for other skin regions affected by an ailment that is susceptible to topical or hair treatment, as well as hair fall or hair loss conditions, or combinations thereof. The medicinal formulation includes shampoo, conditioner, cream, lotion, ointment or other topical skin, scalp or hair treatment or a pill, skin patch, gel, injection pen, subdermal injection packet, IV fluid package, tablet, capsule, lipid carrier, nano-crystal or other nano-particulate formulation, subcutaneous insert, or stent, or combinations thereof, said medicinal formulation comprising a predetermined number of one or more effective doses, each effective dose including between 20-160 mg/kg of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
The medical kit may also include a prognostic kit including a prognostic test kit and a prognostic indicator, wherein the prognostic test kit is configured for measuring a level or combination of levels of one or more of IL-5, IL-13, IL-17, IL-23, TNF-a, IL-6, IL-7, IL-13, GMCSF, MCP-1, IL-9, IL-1-β, IL-l-RA, IL-8, IL-10, IL-12, IL-19, IL-20, IL-22, IL-24, IL-26, eotaxin, FGF-β, G-CSF, IFN-γ, IP- 10, MIP-1, PDGFRB, MIP-1 -β, RANTES, VEGF, JAK, JAKl, JAK3, MPO (myeloperoxidase), p38kinase, BRAF, BRAF V599E, KRAS, EGFR, ALK, TRPV1, TRPAl, MRGPRA3, PAR2, mucunain or other proteases, chloroquine, pruritogen, cowhage, sapsaicin, ROS, RET. SK-Mel-2, HT-29, MCF-7, THP-1, DU-145, MOLT-4, THP-1, K562, HL- 60, U937, PD-1, ICAM-1, VCAM-1, E-selectin, HACAT-THP-1, LYN, ABL, BTK, SYK, ZAP- 70, PI3KCD, AKT, HER-2, FLT-3, KIT, LCK, MAPKl, MEK1, PGE, MMP, PI3K-5, PIK3CD, PIK3R1 CCL3, CCL4, PLC, BCR, CD-5, CD-38, CD-19, CD-20, CD-79a, β2Μ, NO, LTB4, PLA2, or PDE4, OR A KINASE, E.G., AKTl (PKB ALPHA), ERBB2 (HER2), FLT3, MAPKl (ERK2), PRKCA (PKC ALPHA), BRAF, BRAF V599E OR MAP2K1 (MEK1), or combinations thereof, in a second bodily fluid or skin sample, or both, after a prognostic period of treatment, and wherein the prognostic indicator is configured for providing a prognostic result for the patient based on a comparison of said measured level or combination of levels in the first and second bodily fluid or skin sample, or both.
Another medical kit is provided that includes a diagnostic kit and a medicinal formulation. The diagnostic kit includes a test kit and an indicator. The test kit is configured for measuring a level or combination of levels of one or more of IL-5, IL-13, IL-17, IL-23, TNF-a, IL-6, IL-7, IL- 13, GMCSF, MCP-1, IL-9, IL-1-β, IL-l-RA, IL-8, IL-10, IL-12, IL-19, IL-20, IL-22, IL-24, IL- 26, eotaxin, FGF-β, G-CSF, IFN-γ, IP-10, MIP-1, PDGFRB, MIP-1-β, RANTES, VEGF, JAK, JAKl, JAK3, MPO (myeloperoxidase), p38kinase, BRAF, BRAF V599E, KRAS, EGFR, ALK, TRPVl, TRPAl, MRGPRA3, PAR2, mucunain or other proteases, chloroquine, pruritogen, cowhage, sapsaicin, ROS, RET. SK-Mel-2, HT-29, MCF-7, THP-1, DU-145, MOLT-4, THP-1, K562, HL-60, U937, PD-1, ICAM-1, VCAM-1, E-selectin, HACAT-THP-1, LYN, ABL, BTK, SYK, ZAP-70, PI3KCD, AKT, HER-2, FLT-3, KIT, LCK, MAPKl, MEKl, PGE, MMP, PI3K-5, PIK3CD, PIK3R1 CCL3, CCL4, PLC, BCR, CD-5, CD-38, CD-19, CD-20, CD-79a, β2Μ, NO, LTB4, PLA2, or PDE4, OR A KINASE, E.G., AKTl (PKB ALPHA), ERBB2 (HER2), FLT3, MAPKl (ERK2), PRKCA (PKC ALPHA), BRAF, BRAF V599E OR MAP2K1 (MEKl), or combinations thereof, in a bodily fluid or skin sample, or both. The indicator is configured for providing a diagnostic result based on said measured level or combinations of levels and on one or more expected correlations between said level or combination of levels and manifestation of one or more diseases including scalp psoriasis, dermatitis, atopic dermatitis, eczema, herpes, shingles, rheumatoid arthritis (RA), arthritic psoriasis/psoriatic arthritis, Alzheimer's, Parkinson's, irritable bowel syndrome (IBS), colitis, prostitis, vasculitis, osteoarthritis, seborrheic dermatitis, acne, colitis, skin lesions, diabetes, hypertension, allergies, asthma, capuche sarcoma, autoimmune, inflammation, dermatologic, cardiovascular, metabolic syndrome, hypotension, coronary artery disease, depression, lupus, sarcoidosis, muscular sclerosis, Crohn's disease, UV exposure, burns, warts, dandruff, seborrheic dandruff, chronic inflammation, seborrhea, keratosis, alopecia, hirsutism, capitis, melanoma or non-melanoma skin cancer, basal cell cancer (BCC), squamous cell cancer (SCC), scleroderma, dermatofibrosarcoma protuberans, Merkel cell carcinoma, Kaposi's sarcoma, keratoacanthoma, spindle cell tumors, sebaceous carcinomas, microcystic adnexal carcinoma, Paget's disease of the breast, atypical fibroxanthoma, leiomyosarcoma, and angiosarcoma, Marjolin's ulcers, kidney failure, nerve damage caused by a skin condition, or skin burrowing mites, or a skin ailment, lesion or sore, particularly of the scalp and also for other skin regions affected by an ailment that is susceptible to topical or hair treatment, as well as hair fall or hair loss conditions, or combinations thereof. The medicinal formulation includes shampoo, conditioner, cream, lotion, ointment or other topical skin, scalp or hair treatment or a pill, skin patch, gel, injection pen, subdermal injection packet, IV fluid package, tablet, capsule, lipid carrier, nano-crystal or other nano-particulate formulation, subcutaneous insert, or stent, or combinations thereof. The medicinal formulation includes a predetermined number of one or more effective doses, each effective dose including between 1.0wt.%-15wt.% of an herbal combination of Da Huang, Sheng di Huang and Jin Yin Hua.
The medical kit may also include a prognostic kit that includes a prognostic test kit and a prognostic indicator. The prognostic test kit may be configured for measuring a level or combination of levels of one or more of IL-5, IL-13, IL-17, IL-23, TNF-a, IL-6, IL-7, IL-13, GMCSF, MCP-1, IL-9, IL-1-β, IL-l-RA, IL-8, IL-10, IL-12, IL-19, IL-20, IL-22, IL-24, IL-26, eotaxin, FGF-β, G-CSF, IFN-γ, IP- 10, MIP-1, PDGFRB, MIP-1 -β, RANTES, VEGF, JAK, JAKl, JAK3, MPO (myeloperoxidase), p38kinase, BRAF, BRAF V599E, KRAS, EGFR, ALK, TRPVl, TRPA1, MRGPRA3, PAR2, mucunain or other proteases, chloroquine, pruritogen, cowhage, sapsaicin, ROS, RET. SK-Mel-2, HT-29, MCF-7, THP-1, DU-145, MOLT-4, THP-1, K562, HL- 60, U937, PD-1, ICAM-1, VCAM-1, E-selectin, HACAT-THP-1, LYN, ABL, BTK, SYK, ZAP- 70, PI3KCD, AKT, HER-2, FLT-3, KIT, LCK, MAPKl, MEK1, PGE, MMP, PI3K-5, PIK3CD, PIK3R1 CCL3, CCL4, PLC, BCR, CD-5, CD-38, CD-19, CD-20, CD-79a, β2Μ, NO, LTB4, PLA2, or PDE4, OR A KINASE, E.G., AKT1 (PKB ALPHA), ERBB2 (HER2), FLT3, MAPKl (ERK2), PRKCA (PKC ALPHA), BRAF, BRAF V599E OR MAP2K1 (MEK1), or combinations thereof, in a second bodily fluid or skin sample, or both, after a prognostic period of treatment. The prognostic indicator may be configured for providing a prognostic result for the patient based on a comparison of said measured level or combination of levels in the first and second bodily fluid or skin sample, or both.
Effective doses may include 0.2-1.2 grams of Da Huang, 0.6-3.6 grams of Sheng Di Huang and 0.2-1.2 grams of Jin Yin Hua for a 50 kg patient or 0.4-2.4 grams of Da Huang, 1.2-7.2 grams of Sheng Di Huang and 0.4-2.4 grams of Jin Yin Hua for a 100 kg patient.
Effective doses may include 1-6 grams of said herbal combination for a 50 kg patient or 2- 12 grams for a 100 kg patient.
Effective doses may include 2.5wt.%-5.0wt.% of said herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua. Effective doses may include between 20-160 mg/kg of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
Effective doses may include between 20-160 mg/kg of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
Another prognostic kit is provided that includes a medicinal formulation and a prognostic test kit and indicator. The medicinal formulation includes shampoo, conditioner, cream, lotion, ointment or other topical skin, scalp or hair treatment or a pill, skin patch, gel, injection pen, subdermal injection packet, IV fluid package, tablet, capsule, lipid carrier, nano-crystal or other nano-particulate formulation, subcutaneous insert, or stent, or combinations thereof, said medicinal formulation comprising a predetermined number of one or more effective doses, each effective dose including between 20-160 mg/kg of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua. The prognostic test kit is configured for measuring a level or
combination of levels of one or more of IL-5, IL-13, IL-17, IL-23, TNF-a, IL-6, IL-7, IL-13, GMCSF, MCP-1, IL-9, IL-1-β, IL-l-RA, IL-8, IL-10, IL-12, IL-19, IL-20, IL-22, IL-24, IL-26, eotaxin, FGF-β, G-CSF, IFN-γ, IP- 10, MIP-1, PDGFRB, MIP-1 -β, RANTES, VEGF, JAK, JAKl, JAK3, MPO (myeloperoxidase), p38kinase, BRAF, BRAF V599E, KRAS, EGFR, ALK, TRPVl, TRPA1, MRGPRA3, PAR2, mucunain or other proteases, chloroquine, pruritogen, cowhage, sapsaicin, ROS, RET. SK-Mel-2, HT-29, MCF-7, THP-1, DU-145, MOLT-4, THP-1, K562, HL- 60, U937, PD-1, ICAM-1, VCAM-1, E-selectin, HACAT-THP-1, LYN, ABL, BTK, SYK, ZAP- 70, PI3KCD, AKT, HER-2, FLT-3, KIT, LCK, MAPKl, MEKl, PGE, MMP, PI3K-5, PIK3CD, PIK3R1 CCL3, CCL4, PLC, BCR, CD-5, CD-38, CD-19, CD-20, CD-79a, β2Μ, NO, LTB4, PLA2, or PDE4, OR A KINASE, E.G., AKTl (PKB ALPHA), ERBB2 (HER2), FLT3, MAPKl (ERK2), PRKCA (PKC ALPHA), BRAF, BRAF V599E OR MAP2K1 (MEKl), or combinations thereof, in first and second bodily fluid or skin samples, or both, respectively extracted from a patient before and after a prognostic period of treatment with said medicinal formulation. The prognostic indicator is configured for providing a prognostic result for the patient based on a comparison of said measured level or combination of levels in the first and second bodily fluid or skin samples, or both.
Effective doses may include 1.0wt.%-15.0wt.% of said herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
Effective doses may include 2.5wt.%-5.0wt.% of said herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
Another prognostic kit is provided that includes a shampoo, conditioner, cream, lotion, ointment or other topical skin, scalp or hair treatment or a pill, skin patch, gel, injection pen, subdermal injection, IV fluid, tablet, capsule, lipid carrier, nano-crystal or other nano-particulate formulation, subcutaneous insert, or stent, or combinations thereof, that comprises a
predetermined number of one or more effective doses, each effective dose including between 1.0wt.%-15.0wt.% of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua. The prognostic kit also includes a prognostic test kit for measuring a level or combination of levels of one or more of IL-5, IL-13, IL-17, IL-23, TNF-a, IL-6, IL-7, IL-13, GMCSF, MCP-1, IL-9, IL-1- β, IL-l-RA, IL-8, IL-10, IL-12, IL-19, IL-20, IL-22, IL-24, IL-26, eotaxin, FGF-β, G-CSF, IFN-γ, IP- 10, MIP-1, PDGFRB, MIP-1-β, RANTES, VEGF, JAK, JAKl, JAK3, MPO
(myeloperoxidase), p38kinase, BRAF, BRAF V599E, KRAS, EGFR, ALK, TRPVl, TRPA1, MRGPRA3, PAR2, mucunain or other proteases, chloroquine, pruritogen, cowhage, sapsaicin, ROS, RET. SK-Mel-2, HT-29, MCF-7, THP-1, DU-145, MOLT-4, THP-1, K562, HL-60, U937, PD-1, ICAM-1, VCAM-1, E-selectin, HACAT-THP-1, LYN, ABL, BTK, SYK, ZAP-70, PI3KCD, AKT, HER-2, FLT-3, KIT, LCK, MAPKl, MEKl, PGE, MMP, PI3K-5, PIK3CD, PIK3R1 CCL3, CCL4, PLC, BCR, CD-5, CD-38, CD-19, CD-20, CD-79a, β2Μ, NO, LTB4, PLA2, or PDE4, or a kinase, e.g., AKTl (PKB alpha), ERBB2 (HER2), FLT3, MAPKl (ERK2), PRKCA (PKC alpha), BRAF, BRAF V599E or MAP2K1 (MEK1), or combinations thereof, in first and second bodily fluid or skin samples, or both, respectively extracted from a patient before and after a prognostic period of treatment with said medicinal formulation. The prognostic kit also includes a prognostic indicator for providing a prognostic result for the patient based on a comparison of measured levels or combinations of levels from said first and second bodily fluid or skin samples, or both.
Effective doses may include 0.2-1.2 grams of Da Huang, 0.6-3.6 grams of Sheng Di Huang and 0.2-1.2 grams of Jin Yin Hua for a 50 kg patient or 0.4-2.4 grams of Da Huang, 1.2-7.2 grams of Sheng Di Huang and 0.4-2.4 grams of Jin Yin Hua for a 100 kg patient.
Effective doses may include 1-6 grams of said herbal combination for a 50 kg patient or 2- 12 grams for a 100 kg patient.
Effective doses may include 2.5wt.%-5.0wt.% of said herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
Effective doses may include between 20-160 mg/kg of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua.
Herbal combinations of Da Huang, Sheng Di Huang and Jin Yin Hua are provided for treatment of certain diseases. One or more described herbs, herbal extracts and/or molecules are also provided for administration to a patient before, during and/or after administering a treatment regimen with a known medicine, or in a combination therapy, to enhance the effectiveness and/or reduce expected side effects. Herbal combinations including Da Huang, Sheng Di Huang and Jin Yin Hua alone or in combination with one or more other herbs, herbal extracts, molecules and/or other medicines may be used to treat skin ailments or dermatologic conditions such as scalp psoriasis, atopic dermatitis, eczema, herpes, shingles, psoriatic, seborrheic dermatitis, acne, skin lesions, UV exposure, burns, warts, skin delayed type hypersensitivity disorder, and dandruff, as well as inflammation, chronic inflammation and inflammatory diseases such as arthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, refractory rheumatoid arthritis, osteoarthritis, appendicitis, bursitis, colitis, cystitis, dermatitis, phlebitis, vasculitis, rhinitis, tendonitis, tonsillitis and arthritic psoriasis, as well as Alzheimer's disease, Parkinson's disease, multiple sclerosis, IBS, diabetes, hypertension, allergies, asthma, and adult respiratory distress syndrome, as well as autoimmune conditions such as psoriasis, colitis, pemphigus vulgaris, vitiligo, celiac disease, Hashimoto's thyroiditis, SLE, Sjogren's syndrome, sarcoidosis, scleroderma, cryoglobulinemic vasculitis, and dermatomyositis, as well as osteoporosis/bone resorption, cardiovascular disease, metabolic syndrome, hypotension, atherosclerosis, coronary artery disease, depression, and cancers such as melanoma, CLL, AML, leukemia and breast, colon and/or prostate cancer. Markers may be used in formulating a prognosis and/or a diagnosis for a patient, particularly those demonstrating strong correlation with dispositions within patients of certain diseases such as those described above and below herein and/or those demonstrating effectiveness of administration to patients of certain treatments including herbal combinations of Da Huang, Sheng Di Huang and Jin Yin Hua. Markers may be utilized in diagnosis and treatment and/or in formulating a prognosis for treatment with a dosage composition including Da Huang, Sheng Di Huang and Jin Yin Hua alone or in combination with other medicines and/or with other herbs, extracts or molecules.
Markers may be selected from the following non-exhaustive listing of marker types:
Inflammatory cytokines; Growth factors; Cytokine receptors; Ligand to surface markers;
Chemokines; Protoangiogenic mediators; Automicrobial proteins; Neuropeptides; Oxidative stress markers; Dendritic cells (DC); Plasmacytoid DC; Monocytes; Macrophages, histamines; T&B lymphocytes; anti-immune modulators, adhesion molecules, osteoclasts, osteoblasts, tyrosine kinases, and/or Theranostic biomarkers.
Levels of certain markers having known correlations with dispositions of certain diseases may be measured in patient bodily samples, e.g., serum, skin, blood, saliva, for determining a diagnosis and treatment. Levels of certain markers having known correlations with effectiveness of certain treatments including herbal combinations of Da Huang, Sheng Di Huang and Jin Yin Hua, alone or in a combination therapy, may be tested both before and after administration of one or more doses of the herbal therapy or combination therapy for determining a prognosis as to whether the herbal therapy or combination therapy is likely to be effective for this patient.
Among these markers are IL-5, IL-13, IL-17, IL-23 and TNF-a which have shown strong correlation to disposition with certain inflammatory, auto-immune, oncological, and/or dermatological diseases, as well as to responsiveness to administered dosage compositions including Da Huang, Sheng Di Huang and Jin Yin Hua by downregulation in diagnosed patients following treatment. Further example markers include IL-6, IL-7, IL-13, GMCSF and MCP-1 which also showed good correlations both with these diseases and the herbal treatments.
Another example marker is IL-9 which has shown significant correlation with the diseases and herbal treatments.
Additional example inflammatory, autoimmune, dermatologic and oncologic markers include IL-1-β, IL-l-RA, IL-8, IL-10, IL-12, IL-19, IL-20, IL-22, IL-24, IL-26, eotaxin, FGF-β, G-CSF, IFN-γ, IP-10, MIP-1, PDGFRB, MIP-1-β, RANTES, VEGF, JAK, JAK1, JAK3, p38kinase, BRAF, BRAF V599E, KRAS, EGFR, ALK, TRPV1, TRPA1, MRGPRA3, PAR2, mucunain or other proteases, chloroquine, pruritogen, cowhage, sapsaicin, ROS, RET. SK-Mel-2, HT-29, MCF-7, THP-1, DU-145, MOLT-4, THP-1, K562, HL-60, U937, PD-1, ICAM-1, VCAM- 1, E-selectin, HACAT-THP-1, LYN, ABL, BTK, SYK, ZAP-70, PI3KCD, AKT, HER-2, FLT-3, KIT, LCK, MAPKl, MEK1, PGE, MMP, PI3K-5, PIK3CD, PIK3R1 CCL3, CCL4, PLC, BCR, CD-5, CD-38, CD-19, CD-20, CD-79a, β2Μ, NO, LTB4, PLA2, and PDE4.
Psoriasis and eczema/dermatitis are inflammatory, autoimmune and dermatologic diseases. Current management strategies include oral medications, steroid creams and light therapy. An aqueous mixture of three herbs: Rheum palmatum L. (Da Huang), Rehmannia glutinosa Libosch (Sheng di huang) and Lonicera Japonica (Jin Yin Hua) is provided in cream, lotion or shampoo formulation, and in tablets, skin patches, subdermal injections and in nano-formulations including sub-450 nm, sub-350 nm, sub-250 nm, sub- 150 nm and sub- 100 nm particulate sizes, in an approximate ratio of one part (±30%) Da Huang, one part (±30%) Jin Yin Hua and two-four parts Sheng Di Huang. The aforementioned three herb formulations have demonstrated promising anti- psoriatic and anti-eczematic activity in pre-clinical and clinical studies. Further testing is ongoing for determining efficacies in fighting others of the diseases described above and below herein. Herbal formulations including a majority to an entirety of the three herbs Da Huang, Sheng Di Huang and Jin Yin Hua have demonstrated significant inhibitory effects on secretion of TNF-a, TARC and VEGF in keratinocytes (HaCaT), considerable downregulation of IL-6 in RAW264.7 cells and IgE in human myeloma cell line-U-266, as well as inhibition of JAK-l/JAK-3. In addition, lotion, cream, gel, shampoo, foam, subdermal injections, IV, and oral formulations are provided herein.
Diagnostic test kits are provided in accordance with certain embodiments that include diagnosis-based treatments, diagnostic testing that involve novel markers or novel combinations of markers or novel reagents or combinations thereof. An example of a diagnostic test kit in accordance with certain embodiments includes a test kit for measuring certain markers in patient bodily samples (e.g., serum or sera from skin washings, liquid blood serum, keritinocytes, or fibroblasts, or combinations thereof). The example test kit may further include an indicator for communicating a diagnosis to the patient based on the results of the measuring and known correlations between levels of markers and predispositions with one or more diseases, conditions, ailments or disorders. A shampoo, cream, lotion, pills, skin patches, gel, nanogel, injection pens, ointments, subdermal injections, IV bags, tablets, capsules, nano-lipid carriers, nano-chrystals, nano-particulates, subcutaneous implants, stents, or combinations thereof, may be provided with the test kit or may be advised based on the diagnosis, for administering treatment to the patient based on the diagnosis. Prognostic test kits are also provided in accordance with certain embodiments that include a test kit for taking bodily samples from a patient (e.g., skin samples, such as serum or sera from skin washings, liquid blood serum, keritinocytes or fibroblasts, or combinations thereof), and measuring a panel of markers in the bodily samples that have been preselected based on determined/tested relevance to a disease based on a diagnosis (e.g., a kit that simultaneously analyzes multiple cytokines, and may use multiplex technology). The test kit may include a medicine including a combination of one, two or all three of Da Huang, Sheng Di Huang and Jin Yin Hua, alone or in combination with one or more further herbs, molecules or other medicine. The prognostic kit includes a second test kit for taking a second bodily sample and measuring a panel of one or more markers in the second bodily sample. The prognostic kit includes an indicator for communicating a prognosis to the patient based on whether one or more markers went up or down with administration of the medicine and on determined correlations between measured affects on levels of certain markers and administration of the medicine.
A patient stratification method may include categorizing patients based on their particular prognoses (e.g., such that administration of certain medicines such as combinations of Da Huang, Sheng Di Huang and Jin Yin Hua, would only be advised for those patients showing at least a minimum likelihood of response to medicine. A theranostic approach to treatment of the patient may be developed based on the diagnostic and/or prognostic test results.
Combinations of Da Huang, Sheng Di Huang and Jin Yin Hua may be administered along with one or more developed therapies to enhance their effectiveness and/or to reduce certain side effects of the developed therapies and/or to ease a transition off of a developed therapy upon completion of what can be for some patients a grueling, albeit effective, regimen of the developed therapy. Such developed therapies may include one or more of Etanercept, Betamethotrexate, Methotrexate, 5-fluoroviacil, Paclitaxel, Adriamycin (doxorubicin), Etoposide, 5-fluorourasil, Docetaxil, Vincristine, Irinotecan, Methylprednisolone, Carboplatin, Dacarbazine, Acitretin, Glycyrrhizin, Paeonia lactiflora, Glycyrrhiza uralensis, Mahonia aquafolium, Aloe vera, Indigo naturalis, Kaku nut oil, Camptotheca acuminatanut, Calcipotriol, tazarotene, Otezla, Embrel, Humira, Cinzia, Cosentyx, Remicade, Simponi, Taltz, Steroids, Tacrolimus, Prograf,
Cyclosporine, Sulfasalazine, NSAIDS such as naproxen, diclofenac, ibuprofen, and aspirin, acetaminophen, Hydrochloroquine, Corticosteroids, Leflunomide, Biologic DMARDs (disease- modifying antirheumatic drugs), Infliximab, Adalimumab, Anakinra, Dasatinib, Fostamatinib, Rituximab, Tocilizumab and Abatacept, GS-1101, Ibrutinib, steroid cream, Stelara, L. casei, Omega-3 fatty acids, antioxidants, green coffee beans, ginger, garlic, and turmeric. Methods and medicinal compositions are provided for treating psoriasis, eczema, or another other autoimmune or inflammatory condition, or melanoma or another skin ailment, or leukemia or other cancer, or another ailment described herein. The methods include preparing an herbal composition, determining a diagnosis or prognosis for a patient, administering an herbal composition to a patient diagnosed with one or more of these ailments and/or stratifying a patient population based on prognosis. A medicinal composition may include a combination of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua alone or in a majority proportion with one or more other herbal or molecular constituents.
An herbal medicinal composition may be administered alone or in combination with an established treatment regimen such as any of those described herein before, during or after administration of the established regimen. An example two herb combination in accordance with certain embodiments includes Da Huang and Sheng Di Huang. Another two herb combination includes Da Huang and Jin Yin Hua. Another two herb combination includes Sheng Di Huang and Jin Yin Hua. A three herb combination includes Da Huang, Sheng Di Huang and Jin Yin Hua. Other combinations of two to seven herbs selected from among the following seven herbs may be administered to a patient as an effective treatment or supplement to an established treatment regimen in accordance with certain embodiments, the seven herbs including: Da Huang, Sheng Di Huang, and Jin Yin Hua, as well as Mu Dan Pi, Di Gu Pi, Xian He Cao, and Chun Gen Pi.
Figures 1-3 illustrate plots for each of the eighteen herbs of growth as a percentage of control versus dilution factor. Figures 51-53 illustrate that the three herbs Sheng Di Huang, Da Huang and Jin Yin Hua are most effective, while the four herbs Mu Dan Pi, Di Gu Pi, Xian He Cao and Chun Gen Pi are effective, and the eleven herbs Zi Cao, Xuan Shen, Shi Gao, Bai Shao, Chi Shao, Hong Hua, Da Qing Ye, Qing Dai, Bai Zhu, Shi Wei and Rou Gui are somewhat less effective.
Figure 4 illustrates the effect on live cells of five combinations of herbs each in two concentrations 1 :40 and 1 :80. Cal includes a combination of all eighteen herbs, C2 includes a combination of Jin Yin Hua, Da Huang, Mu Dan Pi and Di Gu Pi, C3 includes a combination of Da Huang, Sheng Di Huang and Jin Yin Hua, C4 and C5 include combinations of the other eleven herbs (Zi Cao, Xuan Shen, Shi Gao, Bai Shao, Chi Shao, Hong Hua, Da Qing Ye, Qing Dai, Bai Zhu, Shi Wei and Rou Gui) of the eighteen herbs, i.e., not in combination with any of the seven herbs (Sheng Di Huang, Da Huang, Jin Yin Hua, Mu Dan Pi, Di Gu Pi, Xian He Cao and Chun Gen Pi). Specifically, C4 includes Shi Gao, Shi Wei, Bai Zhu, Rou Gui, Hong Hua and C5 includes Zi Cao, Xuan Shen, Chi Shao, Bai Shao, Da Qin Ye, and Qing Dai. EXAMPLE TREATMENTS AND MEDICINAL DOSAGE COMPOSITIONS
Treatment methods in accordance with certain embodiments may include administering periodic doses of an herbal combination of one or more herbs described herein, such as Da Huang, Sheng Di Huang or Jin Yin Hua, or combinations thereof, as a medicine or medicinal supplement, alone or in combination with a known or discovered treatment, for treating a patient with psoriasis, inflammatory disorders, autoimmune disorders, scalp psoriasis, dermatitis, atopic dermatitis, eczema, herpes, shingles, rheumatoid arthritis (RA), arthritic psoriasis/psoriatic arthritis, Alzheimer's, Parkinson's, irritable bowel syndrome (IBS), colitis, prostitis, vasculitis, osteoarthritis, seborrheic dermatitis, acne, colitis, skin lesions, diabetes, hypertension, allergies, asthma, capuche sarcoma, autoimmune or inflammation related symptoms or disorders, dermatologic or cardiovascular conditions, metabolic syndrome, hypotension, coronary artery disease, depression, lupus, sarcoidosis, muscular sclerosis, Crohn's disease, UV exposure, burns, warts, dandruff, seborrheic dandruff, chronic inflammation, seborrhea, keratosis, alopecia, hirsutism, capitis, melanoma or non-melanoma skin cancer, basal cell cancer (BCC), squamous cell cancer (SCC), scleroderma, dermatofibrosarcoma protuberans, Merkel cell carcinoma, Kaposi's sarcoma, keratoacanthoma, spindle cell tumors, sebaceous carcinomas, microcystic adnexal carcinoma, Paget's disease of the breast, atypical fibroxanthoma, leiomyosarcoma, and angiosarcoma, Marjolin's ulcers, kidney failure, nerve damage caused by a skin condition, or skin burrowing mites, or a skin ailment, lesion or sore, particularly of the scalp and also for other skin regions affected by an ailment that is susceptible to topical or hair treatment, as well as hair fall or hair loss conditions, or combinations thereof.
A treatment method in accordance with certain embodiments may include administering periodic doses methotrexate, and/or another known treatment regimen described herein or as understood by those skilled in the art, along with an herbal combination of one or more herbs described herein, for treating a patient with psoriasis, eczema, melanoma, inflammation or a form of cancer that is known to be effectively treated with methotrexate such as cancer of the breast, skin, head and neck, or lung or rheumatoid arthritis, psoriasis or leukemia.
A treatment method in accordance with certain embodiments may include administering periodic doses of Pemetrexed, Pralatrexate, Methotrexate sodium, Pemetrexed Disodium or a folate analog metabolic inhibitor, alone or in combination with methotrexate, and/or another known treatment regimen described herein or as understood by those skilled in the art, along with an herbal combination of one or more of Da Huang, Sheng Di Huang, and Jin Yin Hua, and/or one or more of the other herbs described herein, for treating a patient with psoriasis, eczema, melanoma, inflammation or another inflammatory or autoimmune disease or form of cancer that is known to be effectively treated with methotrexate or another known treatment described herein or a discovered treatment such as for treating cancer of the breast, skin, bladder, head and neck, or lung, osteosarcoma, lymphoma, or trophoblastic neoplasms, or inflammation, or an autoimmune disease such as rheumatoid arthritis, juvenile dermatomyositis, psoriasis, psoriatic arthritis, lupus, sarcoidosis, capuche sarcoma, Crohn's disease, eczema and many forms of vasculitis, or leukemia or conditions for which immunosuppressive drugs are commonly used, or combinations thereof.
A treatment method in accordance with certain embodiments may include administering periodic doses of an herbal combination of one or more of Da Huang, Sheng Di Huang, and Jin Yin Hua, along with one or more of a class of drugs that are specifically understood for their effectiveness at treating auto immune diseases and/or for curbing bodily rejections after implantation or transplantation of an organ or bone marrow, including drugs that influence lymphocytes such as Azathioprine, Mycophenolate mofetil, Methotrexate and/or
Cyclophosphoamide, and/or durgs that slow down meiosis of lymphocytes such as Cyclosporine, Tacrolimus, Sirolimus (Rapamycin) and/or drugs that neutralize cytokines such as Infliximab, Etanercept, Adalimunab and/or Anikra.
The treatment regimen may include once or twice daily doses, or several doses per day, or two or more weekly doses or otherwise. Doses may be taken more than once or twice a day, while the amounts of each dose would be determined according to the periodicity of the treatments.
EXAMPLE DOSAGE COMPOSITIONS AND COMBINATION THERAPIES
Effective doses of an herbal combination of Da Huang, Sheng Di Huang and Jin Yin Hua have been demonstrated in mice between 1500 mg/kg and 500 mg/kg. Very low doses of 250 mg/kg may also be administered with modest effectiveness and elevated doses between 1500 mg/kg and 3000 mg/kg may be administered as tolerated with enhanced curative potential. This effective dose range in humans is approximately between 162.0 mg/kg and 40.50 mg/kg, while very low formulations of 20.25 mg/kg and high doses between 162 mg/kg and 324 mg/kg are also capable of formulation. The proportions of the three herbs have been shown to be effective at approximately one part Da Huang, one part Jin Yin Hua and between two and four parts Sheng Di Huang.
An elevated dose example for a 100kg patient includes 2.4 grams Da Huang, 2.4 grams Jin Yin Hua and 7.2 grams Sheng Di Huang. For a 50 kg patient, an elevated dose example includes 1.2 grams Da Huang, 1.2 grams Jin Yin Hua and 3.6 grams Sheng Di Huang. A medium dose example for a 100 kg patient includes 1.6 grams Da Huang, 1.6 grams Jin Yin Hua and 4.8 grams Sheng Di Huang. For a 50 kg patient, a medium dose example includes 0.8 grams Da Huang, 0.8 grams Jin Yin Hua and 2.4 grams Sheng Di Huang.
A low dose example for a 100 kg patient includes 0.8 grams Da Huang, 0.8 grams Jin Yin Hua and 2.4 grams Sheng Di Huang. For a 50 kg patient, a medium dose example includes 0.4 grams Da Huang, 0.4 grams Jin Yin Hua and 1.2 grams Sheng Di Huang.
A very low dose example for a 100 kg patient includes 0.4 grams Da Huang, 0.4 grams Jin Yin Hua and 1.2 grams Sheng Di Huang. For a 50 kg patient, a medium dose example includes 0.2 grams Da Huang, 0.2 grams Jin Yin Hua and 0.6 grams Sheng Di Huang.
An elevated dose example for a 100 kg patient includes 2.4-4.8 grams Da Huang, 2.4-4.8 grams Jin Yin Hua and 7.2-14.4 grams Sheng Di Huang. For a 50 kg patient, a high dose example includes 1.2-2.4 grams Da Huang, 1.2-2.4 grams Jin Yin Hua and 3.6-7.2 grams Sheng Di Huang.
In accordance with these examples, formulations may be prepared for and administered to 100 kg patients that include 0.4-4.8 grams Da Huang, 0.4-4.8 grams Jin Yin Hua and 1.2-14.4 grams Sheng Di Huang, and to 50 kg patients including 0.2-2.4 grams Da Huang, 0.2-2.4 grams Jin Yin Hua and 0.6-7.2 grams Sheng Di Huang. A moderate range example for 100kg patients includes 0.8-2.4 grams Da Huang, 0.8-2.4 grams Jin Yin Hua and 2.4-7.2 grams Sheng Di Huang, and that for 50 kg patients includes 0.4-1.2 grams Da Huang, 0.4-1.2 grams Jin Yin Hua and 1.2- 3.6 grams Sheng Di Huang. These example dosage compositions may be administered multiple times in a treatment regimen lasting a few days or weeks or even months at intervals of a few hours to daily, every other day or as needed.
In another example, a treatment regimen may include 1-10 gram daily doses of combinations of Da Huang, Sheng Di Huang and Jin Yin Hua. A treatment regimen may include 2-5 gram daily doses, or approximately 3 gram daily doses. In the 3.0 gram daily dose example, 1.5 gram doses may be administered twice daily, i.e., 1.5 grams twice a day. A total daily dose may be administered in the form of four (4) tablets, e.g., 2 tablets, twice a day, of 1.0 gram each containing 750 mg of a combination of Da Huang, Sheng Di Huang and Jin Yin Hua as well as 250 mg of excipients.
In another example, a psoriasis treatment regimen may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with
Ustekinumab (by Janssen) and/or with another IL-12 and/or IL-23 inhibitor.
In another example, a psoriasis treatment regimen may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with Humira (by Abbott) and/or with another TNF alpha inhibitor. In another example, a psoriasis treatment regimen may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with
Tofacitinib (by Pfizer) and/or with another JAK and/or STAT inhibitor.
In another example, a psoriasis treatment regimen may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with
Secukinumab (by Novartis) and/or another IL-17 inhibitor.
In another example, a psoriasis treatment regimen may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with
Otezla/Apremilast (by Celgene) and/or another PDE4 inhibitor.
In another example, a psoriasis treatment regimen may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with
Briakinumab and/or another p40 subunit of IL-12 and/or IL-23 and/or a humanized p40 monoclonal antibody.
In another example, a psoriasis treatment regimen may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with
Fezakinumab (by Pfizer) and/or another IL-22 inhibitor.
In another example, a psoriasis treatment regimen may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with an IL-20 inhibitor.
In another example, a psoriasis treatment regimen may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with an IL- 23/pl9 inhibitor.
In another example, a psoriasis treatment regimen may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with a JAK3 inhibitor.
In another example, a psoriasis treatment regimen may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with a Thl, Thl7 and/or Th22 cell inhibitor.
In another example, a psoriasis treatment regimen may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with an IFN gamma inhibitor.
In another example, a psoriasis treatment regimen may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with an IL- 17R, IL-19, IL-20, IL-22, sPLA2, NO (nitric oxide), VEGF, IL-24, key tyrosine and/or topoisom erase inhibitor.
In another example, a treatment regimen for IBS (irritable bowel syndrome) and/or colitis may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua, alone, for example Da Huang and Sheng Di Huang as 2HX or including Jin Yin Hua as 3HX, or along with a TNF , IL-8, MTP-3-α, and/or ICAM-1 inhibitor, and/or one or more other inflammatory marker inhibitors. Moreover, a diagnostic or prognostic kit may include a test kit for measuring levels in gastrointestinal cells of one or more of TNF , IL-8, MIP-3-α, and/or ICAM-1 and/or one or more of, or a panel of several, inflammatory markers, and indicating an IBS and/or colitis diagnosis and/or prognosis for treatment.
Diagnostic and/or prognostic test kits are provided herein for each recited condition that include test kits for measuring one or more of, or a panel of several, markers associated with such recited condition, and indicators that provide diagnostics and/or prognostics for a patient. The prognostic and/or diagnostic kits may include one or more of Da Huang, Sheng Di Huang and Jin Yin Hua and/or one or more other herbs, molecules, and/or biologic, protein, molecule or receptor inhibitors or enablers, and/or treatments and/or medicines recited herein.
In another example, a psoriasis treatment regimen may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with one or more of: a topical therapy such as Vitamin D, Calcipotriol, Corticosteroids, Dithranol, Retinoids, Tacrolimus, and/or Salicylic acid; a systemic therapy such as Methotrexate, Cyclosporine, Hydrea (hydroxyurea), and/or Retinoids; a phototherapy such as UV-B, Psoralen plus ultraviolet therapy and/or excimer laser; a combination therapy such as Methotrexate + Etanercept, Adalimumab (Humira®)+Calcipotriol + Betamethasone Dipropionate, and/or Alefacept +ultraviolet B (UVB) phototherapy, methotrexate, cyclosporine, and/or systemic retinoids; an herbal therapy such as Duzhong (Eucommia ulmoides Oliv.), Yerba mate (Ilex paraguariensis), Linseed oil, Fish oil, Indigo naturalis, Turmeric and/or Aloe Vera; and/or a biological and/or small molecule inhibitor and/or an enzyme inhibitor such as Denilukin diftitox, Efalizumab, Alefacept, Ustekinumab and/or Etanercept.
In another example, a rheumatoid arthritis (RA) treatment regimen may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with Humira (by Abbott) and/or with another TNF alpha inhibitor.
In another example, a rheumatoid arthritis (RA) treatment regimen may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with methotrexate. In another example, a rheumatoid arthritis (RA) treatment regimen may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with Enbrel (by Amgen & Pfizer) and/or another TNF alpha inhibitor approved for RA or for both psoriasis & RA.
In another example, a rheumatoid arthritis (RA) treatment regimen may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with Remicade (by Janssen & Merck) and/or another TNF alpha inhibitor approved for RA or for two or more of psoriasis , RA and IBD (irritable bowel disease).
In another example, a rheumatoid arthritis (RA) treatment regimen may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with Infliximab, Etanercept, Adalimumab, Anakinra, methotrexate, hydroxychloroquine, sulfasalazine and/or Leflunomide.
In another example, an Alzheimer's or Parkinson's treatment regimen may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua, alone, or along with another approved Alzheimer's or Parkinson's treatment.
In another example, a rheumatoid arthritis (RA) treatment regimen may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with an IL-17, IL-23, IL23 receptor and/or IL-23 axis inhibitor.
In another example, a RA, IBD and/or MS treatment regimen may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with an IL- 23 or IL-17 or TNF alpha inhibitor.
In another example, an RA, IBD, MS, Alzheimer's, Parkinson's, inflammatory colitis, osteoarthritis, psoriasis, eczema and/or dermatitis treatment may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with an IL-1, IL-6 and/or IL-8 inhibitor.
In another example, an RA, IBD, MS, Alzheimer's, Parkinson's, inflammatory colitis, osteoarthritis, psoriasis, eczema and/or dermatitis treatment may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with a BTK, SYK, ZAP-70, PI3KCD, AKT, HER-2, FLT-3, MAPK1, BRAF, and/or MEK1 inhibitor.
In another example, an approved treatment for AML, ALL, CML, CLL and/or another leukemia or other cancer medication may be supplemented by administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua. In another example, leukemia or other cancer or other disease treatments that include a PD-1, CD279 and/or PD-Ll inhibitor may be supplemented by administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua.
In another example, Desatinib and/or another LYN, BTK and/or ABL inhibitor, and/or Fostamatinib and/or another SYK, FLT3, KIT, LCK, JAL1, JAK3, PLC, AKT and/or BCR inhibitor, and/or Idelalisib (GS-1101) or another P13K delta inhibitor, and/or Ibrutinib and/or another BTK inhibitor and/or Gefitinib and/or another Zap 70 inhibitor, and/or Dasatinib and/or another Lyn inhibitor, or another approved treatment for CLL and/or another leukemia or other cancer medication may be supplemented by administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua.
In another example, an Alzheimer's treatment may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with a T F-alpha, IL-6, IL- 8, IL-12, GMCSF, and/or MCP-1 inhibitor.
In another example, a treatment may include administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with a administration of combinations of two or more of Da Huang, Sheng Di Huang and Jin Yin Hua along with one or more kinase inhibitors, for example, an AKTl (PKB alpha), ERBB2 (HER2), FLT3, MAPKl (ERK2), PRKCA (PKC alpha), BRAF, BRAF V599E and/or MAP2K1 (MEK1) inhibitor.
EXAMPLE FORMULATIONS
In addition to the above active herbal combination ingredient, a medicinal tablet composition is provided for example for oral administration that may include one or more of the following further ingredients: 125 mg of MCC (Avicel), 20 mg of talc powder, 30 mg of aerosol 200, 10 mg of croscarmellose sodium and/or 30 mg of PVPK 30. This example may also include one or more of the following lubrication ingredients: 20 mg of croscarmellose sodium, 5 mg of aerosol 200, 20 mg of talc powder and/or 10 mg of magnesium sterate.
A medicinal cream is also provided for topical administration that includes the above active herbal combination ingredient, in an example concentration of 2.5%, and one or more of the following further ingredients: 2% sesame oil or sesamum indicum (sesame) seed oil, 4% cetostearyl alcohol or cetearyl alcohol, 5% arlacel 165 or glyceryl stearate or PEG- 100 stearate, 3%) light liquid paraffin or mineral oil, 2% cresmer wax EW or ceteareth-20 or cetearyl alcohol, 3%) stearyl stearate, 0.2% butyl hydroxyl toluene or BHT, 4.2% propylene glycol, 0.2%potassium sorbate, 0.2% sodium benzoate, 5% glycerol or glycerin, 0.1%sandalwood oil or santalum album (sandalwood) oil, and 68.6% water. A medicinal cream is also provided for topical administration that includes the above active herbal combination ingredient, in aqueous extract and in an example concentration of 2.5%, and one or more of the following further ingredients: till oil, cetostearyl alcohol, arlacel 165, light liquid paraffin, cresmer wax EW, stearyl stearate, butyl hydroxyl toluene, propylene glycol, sodium methyl paraben, sodium propyl paraben, glycerol, sandalwood oil. A cream placebo may be formulated for clinical trials that substitutes F-24 chocolate brown color TAS and brilliant blue color for the above active herbal combination ingredient.
PREPERATION OF TOPICAL, ORAL OR SUBDERMAL MEDICINE Treatments described herein may be prepared for topical use for treatment of melanoma, eczema, dermatisis, BCC (basal cyr carcinoma) and inflammatory skin diseases like Psoriasis. For example, combinations of herbs and/or herbal extracts as described herein may be prepared as a cream to apply onto the skin. Another known or discovered treatment may be included or may be administered separately before, during or after the herbal treatment. The other known or discovered treatment, along with herbal combinations and/or herbal extract combinations described herein may be injected to infected areas of the skin of a patient using a syringe. An example method for preparation of an external cream in accordance with certain embodiments is provided below.
First, two of more of the herbs may be cooked, for example, as described elsewhere herein or as may be understood or determined by those skilled in the art. A cream is then prepared that may be somewhat more of less than half herbs and half cream, e.g., a 25%-75% liquid of herbs in 1 : 1 ratio and 25%-75 % cream may be used. The herbs can also be prepared as a tincture, e.g., soaking the herbs in alcohol for a period of time such as 2 weeks in a ratio of 1 :3, for example. This herbal liquid can then be mixed with the cream in the same way as described above.
The herbs may be prepared for cooking by grinding and/or homogenizing the herbs.
Grinding may be achieved using a Dyno-mill run once to obtain, e.g., 250nm particle sizes or multiple times down to, e.g., 150nm particle sizes. A high pressure homogenizer may be used, whereby the mixture is pushed through a filter, e.g., a 0.2μπι filter. Sonication or ultrasound may also be used.
Straining may be performed to get an aqueous extract. Lyophilization or freeze drying may be performed to prepare the mixture for in vitro use. Solubilization may be performed along with selection of a concentration of the extract. A cream, tablet, capsule, nano-lipid carrier, nanogel, or nano-chrystals, or nano-particulates may be formulated for administration to human or animal patients. Treatments described herein may also be effective against immunodeficiency diseases such as HIV and AIDS, as well as other conditions affecting or caused by disorders of the immune system. Herbal combinations of one or more of Da Huang, Sheng Di Huang and Jin Yin Hua and/or one or more other herbs or molecules described herein may be administered as a nutritional supplement or as a supplement to an exercise regimen or as an energy supplement or as a pain relief supplement or as a diuretic or sleep aid. NSAIDs, such as ibuprofen, naproxen and aspirin, other non-steroidal anti-inflammatories, acetaminophen, and/or steroidal anti -inflammatories may be combined with an herbal combination of one or more of Da Huang, Sheng Di Huang and Jin Yin Hua and/or one or more other herbs or molecules described herein, with or without administration of a known or discovered treatment, before, during or after the herbal treatment, to treat inflammation or other ailments that are commonly treatable with NSAIDs, including chronic pain. Formulations may be prepared for oral or topical administration as long release, lipidized dosage compositions or as short release non-lipidized formulas.
A cooking process may be performed as in the example of Figures 5A-5B. Referring to Figure 5A, a step 502 in a cooking process may include taking about 25-30 grams of a first herb, e.g., da Huang, and a second herb, e.g., Jin Yin Hua, and grinding in a mixer grinder for three to five minutes or until a fine powder has been mixed and ground. A step 504 in the process may include taking about 75-80 grams of a third herb, e.g., Sheng di Huang, and grinding in a mixer grinder for three to five minutes or until a fine powder has been mixed and ground.
A step 506 in the cooking process may further include grinding 25 grams of the first herb, e.g., da Huang, 25 grams of the second herb, e.g., Jin Yin Hua, and 75 grams of the third herb, e.g., Sheng di Huang, and mixing thoroughly to prepare a three herb combination ("3HX").
A next step 508 may include weighing about 25 grams of the powdered three herb combination 3HX in a 2000 ml beaker or other suitable container. A next step 510 may include adding water (RT) to the 25 grams of powdered three herb combination 3HX in a ratio of about 20 ml water per gram of powdered three herb combination and pouring the mixture along with a magnetic bead into the beaker. A next step 512 may include allowing the aqueous three herb combination to soak in distilled water for around 15 minutes before boiling.
Referring now to Figure 5B, a hot plate may be pre-heated, for 10 minutes, e.g., before keeping the beaker for boiling, as indicated at step 522. A step 524 may then include boiling the mixture to 85-90°C. A step 526 may include allowing the mixture to come down to 70-75 °C after removing the mixture from the hot plate. A step 528 may include covering the beaker properly with aluminum paper and cooking the mixture at 70°C on a hot plate. A time of cooking in accordance with the example of step 530 from the beginning to the end should be around 60 minutes which includes boiling, cooling and cooking.
A next step 532 may include straining the mixture with the help of a manual strainer. A step 534 may involve filtering the sample and measuring the total volume obtained, as well as making up an obtained extract up to 425 ml, centrifuging the extract obtained after making up at 4000 rpm for 30 minutes and collecting the supernatant.
A cream or lotion or shampoo or ointment or gel or patch or other topical formulation may be prepared. Also, a pill may be prepared in lipidized or non-lipidized form, and coated or uncoated for extended release, timed release, sustained release, modified release, immediate release, quick release, delayed release, controlled release, controlled delivery, long-acting or sustained action. Also, an IV or subdermal injection fluid may be formulated.
In the example of Figure 6, an aqueous extract, e.g., including a herein-described one, two or three (or more) herb combination is prepared, e.g., in accordance with the example of Figures 5A-5B, or otherwise prepared, provided or acquired at step 602. A step 604 may include converting the aqueous extract into powder form. The converting into powder form of step 604 may include one or more of lyophilization or freeze drying 606, vacuum drying 608 and/or spray drying 610. The drying may include heating or proximate hygroscopic disposition or spinning or otherwise as may understood by those skilled in the art.
At step 612, the lyophilized or otherwise dried one, two or three (or more) herb powder may be used to formulate a tablet, pill, capsule or other orally-administered formulation. Such orally-administered formulation may be uncoated 614 or color coated 616. Batch sizes may be in multiples of one or more thousand.
Referring to Figure 7, an example of a shampoo in accordance with certain embodiments is illustrated as including nine generalized components. These nine components include a surfactant, a thickening agent, a pH adjuster/buffer, an aesthetic additive, water, a conditioner, one or more active herbs or herbal extracts or molecules, a preservative and moisturizers/vitamins. Shampoos in accordance with various alternative formulations may include fewer than all of these nine components and they may include other active or inactive components known to those skilled in the art as having some advantage when included in a shampoo formula or in a medicinal combination for treating a skin condition such as psoriasis, eczema, melanoma, or dermatitis or hair loss or another head or scalp disorder or ailment.
A shampoo in accordance with certain embodiments includes one or more surfactants that may be known or discovered as being advantageous for cleaning hair with a shampoo. A primary surfactant may be included to provide flash foam for cleaning the hair by removing dirt and other impurities. A secondary surfactant may be included to provide stable foam and to reduce the harshness of the primary surfactant. A surfactant may be used that includes a charged, hydrophilic head group and a long, hydrophobic alkyl chain tail. Surfactants are configured to break molecular bonds between dirt and hair and to transport the dirt into an aqueous medium to be rinsed free from the hair and scalp. Examples of surfactants that may be contained in a shampoo in accordance with certain embodiments include sodium laureth sulphate, ammonium laureth sulfate, and sodium cocoyl isethionate. Examples of co-surfactants include cocamide MEA and cocoamidopropyl betaine.
A shampoo in accordance with certain embodiments may include a thickening or suspending agent. Examples of thickening or suspending agents that may be contained in accordance with certain embodiments include carbomer and PEG 150 distearate. The thickening agent may be included to stabilize the shampoo during storage and/or to prevent the setting or dumping of pigments and silicone.
A pH adjuster or buffer may be included in a shampoo in accordance with certain embodiments. An example of a pH adjuster or buffer includes citric acid, tartaric and sodium hydroxide. The pH adjuster or buffer is configured to cause the shampoo to be gentle to the skin. A lower pH may cause hair to be compact and to shine and to protect the surfactant from hydrolysis, and as such, the pH adjuster or buffer may serve to lower the pH of the shampoo. However, alternative embodiments include pH adjusters that serve to raise the pH of a shampoo that contains an herbal formula that exhibits an exceptionally low pH.
An aesthetic additive may be included in a shampoo in accordance with certain
embodiments. Examples of aesthetic additives include colorants, opacifiers, UV absorbers, perfumes and natural and artificial fragrances.
One or more conditioners may be included in a shampoo in accordance with certain embodiments. The one or more conditioners may include a cationic polymer such as guar hydroxypropyl trimonium chloride. The one or more conditions may include silicone and/or a silicone emulsion such as dimethiconol, dimethicone, or amodimethicone. The silicone and/or silicone emulsion may serve to coat the hair and cause the hair to become soft, smooth and shiny.
A shampoo in accordance with certain embodiments includes one or more active herbs or herbal extracts or emotives that are described in several examples herein. These one or more active herbs or herbal extracts serve to promote treatment of certain hair and scalp conditions such as psoriasis, eczema, dermatitis, melanoma, hair loss and other hair or scalp conditions described herein or understood by those skilled in the art. A preservative may be included in a shampoo in accordance with certain embodiments. The preservative may be configured to prevent microbial growth. Examples of preservatives that may be contained in a shampoo in accordance with certain embodiments include paraben free, formaldehyde donor free and halogenated free.
A moisturizer and/or one or more vitamins may be included in a shampoo in accordance with certain embodiments. Examples include combinations of D-Panthenol, vitamin E acetate, sodium PC A, glycerine and one or more amino acids. The moisturizer and/or vitamins may be configured to penetrate into hair shaft, seal cuticles and keep hair moisturized.
A shampoo in accordance with certain embodiments may include a hydro-alcoholic hair serum. Referring to Figure 8, a hair growth cycle includes exogen, anagen, catagen and tetogen phases. The anagen phase involves active hair growth, whereby hair follicles regenerate and generate pigmented hair shafts. The telogen phase is a resting phase. The catagen phase involves cessation of hair growth and pigmentation, and release of papilla from the bulb. A hydro- alcoholic hair serum may be configured as a concentrated product that is typically left on the hair for a more extended duration than an ordinary shampoo with a typical shower routine. The hydro- alcoholic hair serum may be configured to be light and non-sticky on the scalp and as a non- irritant, to be light and non-sticky on the hair, to have little or no effect on hair volume, to strengthen scalp and DPC, to provide keratinization and collagen synthesis, to promote hair growth or to control hair fall, or combinations thereof. For example, the attributes of a hydro- alcoholic hair serum in accordance with certain embodiments may assist or promote treatment of psoriasis, seborrhea dandruff or hair fall. A hydro-alcoholic hair serum in accordance with certain embodiments may include water, alcohol, humectant, solubilizer, water-based polymer, scalp conditioner, niacinamide, caffeine and panthenol. The ratio of alcohol, water and solubilizer may be adjusted depending of the solubilization power of the active herbal treatment composition.
Figure 9 schematically illustrates certain targets of medicinal compositions including combinations of Da Huang, Sheng Di Huang and Jin Yin Hua (3HX), in accordance with certain embodiments. Figure 9 illustrates a hyper proliferation of keratinocytes 902, e.g., as may be present in a patient suffering with an inflammatory skin condition, or melanoma, or an
autoimmune or other disorder involving the skin, or combinations thereof. 3HX may be administered to the patient to target keratinocyte-related activities 904, e.g., to inhibit MAP2K1 (MEK1) and MAPKl (ERK2), AKT1 (PKB alpha) and F-kB, p53, PKC alpha, PARP, topoisomerase-II, e.g., influencing Annexin-V, mitochondrial potential leading to inflammatory cytokines 906 and inflammation 908, Caspase-3 and/or cell cycles toward keratinocyte survival 910 and/or DNA fragmentation toward apoptosis 912. Figure 9 also illustrates that 3HX may be administered to a patient to target inflammatory cytokine activity 906 such as that of T F alpha, IFN gamma, IL-6, sPLA2 and/or NO that may otherwise lead to inflammation 908.
Figure 9 also illustrates that 3HX may be administered to a patient to target angiogenesis activity 914 such as that of VEGF, VEGFR2 and/or neutrophil that may activate keratinocytes and influence endothelial cells and/or skin post-capillary venules.
Figure 9 also illustrates that 3HX may be administered to a patient to target inflammation 908 and particularly inflamed immune cell activity 916 such as that of IL-17 and/or IL-23 that may otherwise lead to inflammation.
Figure 10 schematically illustrates certain putative mechanisms of action of medicinal compositions including combinations of Da Huang, Sheng Di Huang and Jin Yin Hua, in accordance with certain embodiments. Figure 10 further illustrates 3HX targeting of lymph nodes 1002, antigen presentation 1004, clonal expansion 1006, T-cells 1008 that may reactivate in the dermis 1010 and/or epidermis 1012 leading to keratinocyte changes 1014, whereby such progress may be slowed by specific binding 1016, cytokine release 1018, psoriatic plaque 1020, and/or antigen MHC complexes 1022.
Figure 11 schematically illustrates certain current psoriasis therapies that may be combined with administration of medicinal compositions including combinations of Da Huang, Sheng Di Huang and Jin Yin Hua, in accordance with certain embodiments. Such therapies may apply to skin, scalp and/or hair disorders, or other inflammatory, autoimmune and/or ontological disorders, that a patient may suffer from other than or in addition to psoriasis. Figure 11 illustrates that therapies may include one or more topical therapies 1102 such as vitamin D, calcipotriol, corticosteroids, dithranol, retinoids, tacrolimus and/or salicylic acid, one or more systemic therapies 1104 such as methotrexate, cyclosporine, hydrea (hydroxyurea) and/or retinoids, one or more phototherapies 1106 such as UV-B, psoralen plus UV therapy and/or excimer laser therapy, one or more combination therapies 1108 such as methotrexate+etanercept, adalimumab
(Humira)+calcipotriol+betamethasone dipropionate, alefacept+UV-B, methotrexate, cyclosporine and/or systemic retinoids, one or more herbal therapies 1110 such as duzhong (eucommia ulmoides oliv.), yerba mate (Ilex paraguariensis), linseed oil, fish oil, indigo naturalis, turmeric and/or aloe vera and/or one or more biological inhibitors, small molecule inhibitors and/or enzyme inhibitors 1112 such as denilukin diftitox, efalizumab, alefacept, ustekinumab and/or etanercept.
Figure 12 schematically illustrates certain inflammatory mediators and targets for rheumatoid arthritis (RA) therapies such as medicinal compositions including combinations of Da Huang, Sheng Di Huang and Jin Yin Hua (3HX), in accordance with certain embodiments. Figure 12 illustrates that administration of 3HX may be provided to a patient to target upregulation of adhesion molecules 1202, increased inflammatory cytokines 1204, induction of prostaglandin (PGE) and matrix metalloproteinases (MMP) 1206, activation of osteoclasts and/or
downregulation of osteoblast activity 1208 and/or angiogenesis 1210.
Figure 13 schematically illustrates certain drugs targeting markers for chronic lymphocytic leukemia (CLL) that may be combined with medicinal compositions including combinations of Da Huang, Sheng Di Huang and Jin Yin Hua (3HX), in accordance with certain embodiments. Figure 13 illustrates markers targets for treatments for CLL including ibrutinib 1302 or a BTK inhibitor 1316 or PCI-32765 1302, obinutuzumab 1304 or a B-cell receptor inhibitor 1322, anti- CD- 19 monoclonal antibody (GBR401) 1306, as well as anti-CD20, anti-CD79a, anti-CCL3, and anti-CCL4, Gefitinib 1308 or a zap70 inhibitor 1308, dasatinib 1310 or a lyn inhibitor 1324 and/or P13kinase inhibitor 1326, fostamatinib 1312 or a syk inhibitor 1328, idelalisib (GS-1101) 1314, alemtuzumab 1318 and Bel -2 inhibitors 1320. 3HX administration to a patient may be useful in targeting one or more of these mechanisms alone or in combination with a known therapy. Other activities such as may involve beta2 microglobulin may also be influenced by 3HX treatment.
Figure 14 schematically illustrates neuroinflammation in Alzheimer's disease and certain targets for medicinal compositions including combinations of Da Huang, Sheng Di Huang and Jin Yin Hua (3HX), in accordance with certain embodiments. 3HX 1402 and/or catechin, genistein and/or luteolin 1404 may be administered to target ROS, NO, PGE2, TNF alpha, IL-lbeta and/or IL-6 activity 1405 and/or NF-kappaB, AP-1, NOS, COX-2, NAPDH and/or oxidase in microglial cellsl406. Epicatechin 1408 may target beta amyloid plaques 1410, beta amyloid aggregates 1411 and/or activated astrocytes 1412 and/or other factors that can tend to cause or facilitate
neurotoxicity 1414 and/or neuroinflammation 1416 and/or affecting cholinergic neuron activity 1418.
EXAMPLES
Certain embodiments are directed to advantageous medicines and methods of treatment and preparation of medicines and treatments for psoriasis, eczema, melanoma or other skin ailments, inflammation, autoimmune disease, leukemia or another form of cancer wherein combinations of methotrexate and/or another known or discovered treatment with an herbal combination such as Da Huang and Sheng Di Huang, or Da Huang, Sheng Di Huang and Jin Yin Hua, and/or one or more of Mu Dan Pi, Di Gu Pi, Xian He Cao and/or Chun Gen Pi, and/or any one or more of the following eleven additional herbs including Zi Cao, or radix arnebiae (arnebia root) or radix lithospermi (gromwell root), Xuan Shen, or radix scrophulariae (figwort root), Shi Gao or gypsum fibrosum (gypsum), Bai Shao, or radix paeoniae alba (white peony root), Chi Shao or radix paeoniae rubra (red peony root), Hong Hua or flos carthami (safflower), Da Qing Ye or folium isatidis (woad leaf), Qing Dai or indigo naturalis (natural indigo), Bai Zhu or rhizoma atractylodis macrocephalae (largehead atractylodes rhizome), Shi Wei or folium pyrrosiae (shearer's pyrrosia leaf), and/or Rou Gui or cortex cinnamomi (cinnamomum bark).
Etanercept, Betamethotrexate, Methotrexate, 5-fluoroviacil, Paclitaxel, Adriamycin (doxorubicin), Etoposide, 5-fluorourasil, Docetaxil, Vincristine, Irinotecan, Methylprednisolone, Carboplatin, Dacarbazine, Acitretin, Glycyrrhizin, Paeonia lactiflora, Glycyrrhiza uralensis, Mahonia aquafolium, Aloe vera, Indigo naturalis, Kaku nut oil, Camptotheca acuminatanut, Calcipotriol and tazarotene gel, Otezla, Embrel, Humira, Cinzia, Cosentyx, Remicade, Simponi, Taltz, one or more steroids, Tacrolimus, Prograf, or cyclosporine, or combinations thereof, or another known treatment described herein or understood or discovered by those skilled in the art may be combined with one, two or all three of Da Huang, Sheng Di Huang and Jin Yin Hua, alone or in combination with certain herbal, molecular or synthetic medicinal dosage compositions, or ingredients thereof, such as digoxin "D" and/or emodin "E," and/or one or more others described above including Emodin, Rhein, and/or Rhapontin of Da Huang, Carvacrol, Vanillic acid, and/or Sitosterol of Jin Yin Hua, and/or Aucubin, Digoxin, and/or beta-sitosterol of Sheng Di Huang and/or other ingredients present within the two, the three, the seven and/or even the eighteen herbs, are used to inhibit tumor cell growth and/or reduce white cell count.
A known treatment, such as those recited above or elsewhere herein, or a discovered treatment, may be combined with an herbal combination of one or more of the herbs described herein and/or one or more molecules, molecular extracts or herbal ingredients described herein. The known or discovered treatment may be administered before, during and/or after
administration of the herbal and/or molecular treatment, and these may be administered together or separately, at the same time or temporally spaced apart in accordance with various
embodiments.
In certain embodiments, herbal combinations may include treatment regimens of various per dose amounts and various numbers of doses over the course of the regimen at various dose frequencies depending on the various specific patient-related factors. For example, a regimen of one or more doses may include, in one example, between 13.3 grams to 120 grams of Sheng Di Huang, or 3.3 grams to 60 grams of Da Huang, or both, alone or together, or in combination with Jin Yin Hua and/or one of more other herbs, and/or in combination with additional emodin or digoxin or another molecule described herein, or combinations thereof. The herbal combinations may be administered in a treatment regimen over a period of time including administration of daily doses or 2-3 times daily doses before meals or up to lOx daily doses or less than daily doses even as little as three doses a month, and the herbal combinations may be administered before, during and/or after administration of a regimen of Etanercept, Betamethotrexate, Methotrexate, 5- fluoroviacil, Paclitaxel, Adriamycin (doxorubicin), Etoposide, 5-fluorourasil, Docetaxil,
Vincristine, Irinotecan, Methylprednisolone, Carboplatin, Dacarbazine, Acitretin, Glycyrrhizin, Paeonia lactiflora, Glycyrrhiza uralensis, Mahonia aquafolium, Aloe vera, Indigo naturalis, Kaku nut oil, Camptotheca acuminatanut, Calcipotriol and tazarotene gel, Otezla, Embrel, Humira, Cinzia, Cosentyx, Remicade, Simponi, Taltz, one or more steroids, Tacrolimus, Prograf, or cyclosponne, or combinations thereof, and/or another known or discovered treatment. Many other example dosage compositions and treatment regimens are provided herein.
Any of Da Huang, Sheng Di Huang and Jin Yin Hua may be administered as a single herb complement or supplement along with another known or discovered treatment regimen. Any two of these herbs, or all three of them, may also be combined and administered as a supplement or complement to another known or discovered treatment regimen. In certain embodiments, the regimen described includes 3.3 grams to 60 grams of Jin Yin Hua. In other embodiments, one or more molecules, molecular extracts and/or molecular compounds are included in the regimen. In further embodiments, one, two, three or all four of the herbs Mu Dan Pi, Xian He Cao, Chun Gen Pi and Di Gu Pi is/are combined with one, two or all of the three herbs Sheng Di Huang, Da Huang and Jin Yin Hua, including 3.3 grams to 15 grams of any of the other four of the seven herbs, e.g., 3.3 grams to 15 grams of Mu Dan Pi, 3.3-10 grams to 15 grams of Xian He Cao, 3.3- 10 grams to 15 grams of Chun Gen Pi, and/or 3.3-5 grams to 15 grams of Di Gu Pi.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula including the three herbs including 3.3-20 grams of Da Huang, 10-60 grams of Sheng Di Huang, and 3.3-20 grams of Jin Yin Hua.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula including 3.3-20 grams of Da Huang and 10-60 grams of Sheng Di Huang.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula including 3.3-20 grams of Jin Yin Hua and 10-60 grams of Sheng Di Huang.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula including 3.3-20 grams of Da Huang and 3.3-20 grams of Jin Yin Hua.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula including the one herb including 3.3-30 grams of Da Huang.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula including the one herb including 3.3-30 grams of Jin Yin Hua. In another example, a known or discovered treatment regimen is supplemented with a low dose formula including the one herb including 10-90 grams of Sheng Di Huang. In another example, a known or discovered treatment regimen is supplemented with a medium dose formula including the three herbs including 10-100 grams of Da Huang, 25-250 grams of Sheng Di Huang, and 10-100 grams of Jin Yin Hua.
In another example, a known or discovered treatment regimen is supplemented with a medium dose formula including 10-100 grams of Da Huang and 25-250 grams of Sheng Di Huang.
In another example, a known or discovered treatment regimen is supplemented with a medium dose formula including 10-100 grams of Jin Yin Hua and 25-250 grams of Sheng Di Huang.
In another example, a known or discovered treatment regimen is supplemented with a medium dose formula including 10-100 grams of Da Huang and 10-100 grams of Jin Yin Hua.
In another example, a known or discovered treatment regimen is supplemented with a medium dose formula including the one herb including 10-100 grams of Da Huang.
In another example, a known or discovered treatment regimen is supplemented with a medium dose formula including the one herb including 10-100 grams of Jin Yin Hua.
In another example, a known or discovered treatment regimen is supplemented with a medium dose formula including the one herb including 25-250 grams of Sheng Di Huang.
In another example, a known or discovered treatment regimen is supplemented with a high dose formula that includes 30-300 grams of Da Huang, 60-600 grams of Sheng Di Huang, and 30- 300 grams of Jin Yin Hua.
In another example, a known or discovered treatment regimen is supplemented with a high dose formula that includes 30-300 grams of Da Huang, and 60-600 grams of Sheng Di Huang.
In another example, a known or discovered treatment regimen is supplemented with a high dose formula that includes 30-300 grams of Da Huang and 30-300 grams of Jin Yin Hua.
In another example, a known or discovered treatment regimen is supplemented with a high dose formula that includes 60-600 grams of Sheng Di Huang and 30-300 grams of Jin Yin Hua.
In another example, a known or discovered treatment regimen is supplemented with a high dose formula that includes 30-300 grams of Da Huang.
In another example, a known or discovered treatment regimen is supplemented with a high dose formula that includes 30-300 grams of Jin Yin Hua.
In another example, a known or discovered treatment regimen is supplemented with a high dose formula that includes 60-600 grams of Sheng Di Huang. In another example, a known or discovered treatment regiment is supplemented with an herbal combination that includes 25-75 grams of Da Huang, 45-135 grams of Sheng Di Huang, and 25-75 grams of Jin Yin Hua in about 250-750 grams of water, or in dry or lipidized form for oral, topical, sub-dermal or IV administration.
In another example, a known or discovered treatment regimen is supplemented with a low dose herbal formula that includes 3.3-10 grams of Da Huang, and 13.3-40 grams of Sheng Di Huang in about 100-300 grams of water, or in dry or lipidized form for oral, topical, sub-dermal or IV administration.
In another example, a known or discovered treatment regimen is supplemented with a high dose herbal formula that includes 30-100 grams of Da Huang and 60-200 grams of Sheng Di Huang in about 600-6000 grams of water, or in dry or lipidized form for oral, topical, sub-dermal or IV administration.
In another example, a known or discovered treatment regimen is supplemented with a medium dose herbal formula that includes 10-50 grams of Da Huang and 30-150 grams of Sheng Di Huang in about 400-2000 grams of water, or in dry or lipidized form for oral, topical, sub- dermal or IV administration.
In another example, a known or discovered treatment regimen is supplemented with a medium dose herbal formula that includes 20-50 grams of Da Huang and 40-100 grams of Sheng Di Huang in about 600-5000 grams of water, or in dry or lipidized form for oral, topical, sub- dermal or IV administration.
In another example, a known or discovered treatment regimen is supplemented with a medium dose herbal formula that includes 15-100 grams of Da Huang and 45-300 grams of Sheng Di Huang in about 600-4000 grams of water, or in dry or lipidized form for oral, topical, sub- dermal or IV administration.
In another example, a known or discovered treatment regimen is supplemented with a medium dose herbal formula that includes 25-75 grams of Da Huang in about 300 grams water, and 50-150 grams of Sheng Di Huang in about 500 grams of water, or in dry or lipidized form for oral, topical, sub-dermal or IV administration.
LOW DOSE FORMULATIONS AND SUPPLEMENTS
In an example involving a combination of a known or discovered regimen and a low dose combination of the three herbs, 0.01-0.4 grams of Sheng Di Huang in 1-6 grams of water, 0.01-0.2 grams of Da Huang in 0.1-6 grams of water and 0.01-0.4 grams of Jin Yin Hua in 0.1-6 grams of water may be combined in a single or multiple treatment dosage regimen and administered to a patent. The combination may be cooked once or twice, and the herb:liquid ratio may be 1 : 10 or otherwise, and the herbs may be prepared in multiple ways, including as dry, aqueous or lipidized components. The doses may be administered every 1-10 days or multiple times daily including 2- 6 times daily, and even as often as 10 times daily.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula including the three herbs including 0.3-3.3 grams of Da Huang, 1-6 grams of Sheng Di Huang, and 0.3-3.3 grams of Jin Yin Hua.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula including 0.3-3.3 grams of Da Huang and 1-6 grams of Sheng Di Huang.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula including 0.3-3.3 grams of Jin Yin Hua and 1-6 grams of Sheng Di Huang.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula including 0.3-3.3 grams of Da Huang and 0.3-3.3 grams of Jin Yin Hua.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula including the one herb including 0.3-3.3 grams of Da Huang.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula including the one herb including 0.3-3.3 grams of Jin Yin Hua.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula including the one herb including 0.1-10 grams of Sheng Di Huang.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula including the three herbs including 0.1-10 grams of Da Huang, 0.25-25 grams of Sheng Di Huang, and 0.10-10 grams of Jin Yin Hua.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula including 0.10-10 grams of Da Huang and 0.25-25 grams of Sheng Di Huang.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula including 0.1-10 grams of Jin Yin Hua and 0.25-25 grams of Sheng Di Huang.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula including 0.1-10 grams of Da Huang and 0.1-10 grams of Jin Yin Hua.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula including the one herb including 0.1-10 grams of Da Huang.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula including the one herb including 0.1-10 grams of Jin Yin Hua.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula including the one herb including 0.25-25 grams of Sheng Di Huang. In another example, a known or discovered treatment regimen is supplemented with a low dose formula that includes 0.3-3 grams of Da Huang, 0.6-6 grams of Sheng Di Huang, and 0.3-3 grams of Jin Yin Hua.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula that includes 0.3-3 grams of Da Huang, and 0.6-6 grams of Sheng Di Huang.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula that includes 0.3-3 grams of Da Huang and 0.3-3 grams of Jin Yin Hua.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula that includes 0.6-6 grams of Sheng Di Huang and 0.3-3 grams of Jin Yin Hua.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula that includes 0.3-3 grams of Da Huang.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula that includes 0.3-3 grams of Jin Yin Hua.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula that includes 0.6-6 grams of Sheng Di Huang.
In another example, a known or discovered treatment regiment is supplemented with a low dose herbal formula that includes 0.1-10 grams of Da Huang in about 1-100 grams water, or in dry or lipidized form for oral, topical, sub-dermal or IV administration.
In another example, a known or discovered treatment regiment is supplemented with a low dose herbal formula that includes 0.25-25 grams of Sheng Di Huang in about 2.5-250 grams of water, or in dry or lipidized form for oral, topical, sub-dermal or IV administration.
In another example, a known or discovered treatment regimen is supplemented with a low dose herbal formula that includes 0.1 -10 grams of Jin Yin Hua in about 1.0-100 grams of water, or in dry or lipidized form for oral, topical, sub-dermal or IV administration.
In another example, a known or discovered treatment regimen is supplemented with a low dose herbal formula that includes 0.2-2.0 grams of Da Huang, 0.4-4.0 grams of Sheng Di Huang, and 0.2-2.0 grams of Jin Yin Hua in about 4-40 grams of water or more, or in dry or lipidized form for oral, topical, sub-dermal or IV administration.
In another example, a known or discovered treatment regimen is supplemented with a low dose formula that includes 0.15-1.5 grams of Da Huang, 0.35-3.5 grams of Sheng Di Huang, and 0.15-1.5 grams of Jin Yin Hua in about 3-30 grams of water or more, or in dry or lipidized form for oral, topical, sub-dermal or IV administration.
In another example, a known or discovered treatment regiment is supplemented with an herbal combination that includes 0.25-0.75 grams of Da Huang, 0.45-1.35 grams of Sheng Di Huang, and 0.25-0.75 grams of Jin Yin Hua in about 25-75 grams of water, or in dry or lipidized form for oral, topical, sub-dermal or IV administration.
In another example, a known or discovered treatment regimen is supplemented with a low dose herbal formula that includes 0.33-1.0 grams of Da Huang, and 1.33-4 grams of Sheng Di Huang in about 10-30 grams of water, or in dry or lipidized form for oral, topical, sub-dermal or IV administration.
In another example, a known or discovered treatment regimen is supplemented with a high dose herbal formula that includes 0.30-1.0 grams of Da Huang and 0.6-2.0 grams of Sheng Di Huang in about 6-60 grams of water, or in dry or lipidized form for oral, topical, sub-dermal or IV administration.
In another example, a known or discovered treatment regimen is supplemented with a low dose herbal formula that includes 0.10-0.50 grams of Da Huang and 0.30-1.5 grams of Sheng Di Huang in about 4-20 grams of water, or in dry or lipidized form for oral, topical, sub-dermal or IV administration.
In another example, a known or discovered treatment regimen is supplemented with a low dose herbal formula that includes 0.20-0.50 grams of Da Huang and 0.40-1.0 grams of Sheng Di Huang in about 6-50 grams of water, or in dry or lipidized form for oral, topical, sub-dermal or IV administration.
In another example, a known or discovered treatment regimen is supplemented with a low dose herbal formula that includes 0.15-1.0 grams of Da Huang and 0.45-3.0 grams of Sheng Di Huang in about 6-40 grams of water, or in dry or lipidized form for oral, topical, sub-dermal or IV administration.
In another example, a known or discovered treatment regimen is supplemented with a low dose herbal formula that includes 0.25-0.75 grams of Da Huang in about 1-3 grams water, and 0.10-1.50 grams of Sheng Di Huang in about 1-5 grams of water, or in dry or lipidized form for oral, topical, sub-dermal or IV administration.
Examples of medium and high dose, and reduced and low dose herbal formulas for supplementing a known or discovered treatment regimen before, during or after administration of said known or discovered treatment regimen include one or more of the other herbs described herein, such as any of herbs contained in the seven herb and eighteen herb combinations described herein, that are administered in doses that are the same as or similar to or commensurate with the medium and high dose, and reduced and low dose example formulas for the one, two and three herb combinations described herein, including corresponding percentage changes when four or more herbs are included in the supplemental herbal formula that is administered before during or after a known or discovered treatment regimen. Many other combinations may be used depending on characteristics of the patient such as age and weight, the condition of the patient, and the patient's history.
Doses in between the low dose and high dose examples for the formulas that include one, two, or three or more herbs, or the seven herb formula, or the eighteen herb formula are also within the scope of further examples with per herb doses and/or total herb doses that are within the ranges provided in the examples above. Under certain conditions, doses above the high dose formula or below the low dose formula may be used as determined by a physician using his or her expertise and experience both generally in the field and with specific patients. In addition, other combinations of two, three, four, five, or more of these 18 herbs, and/or including one or more other herbs as understood by those skilled in the art, may be used in further examples of formulas wherein the dose ranges described in the above examples or otherwise as determined by a physician may be used. Further herbs not described herein may also be included in formulas including combinations of the described herbs and/or molecules, molecular extracts or molecular compounds described herein or understood by those skilled in the art.
Surprise effectiveness is also provided by very low dose herbal combinations of Da Huang, Sheng Di Huang and Jin Yin Hua and by combinations of low doses of one or more of Da Huang, Sheng Di Huang and JinYin Hua with certain herbal extracts, molecules and/or known medicines. Examples includes
In the examples above, certain doses of herb combinations have been described in certain amounts of water. Mixing the herbs in water is only one example of a way to take the herbal combinations. Instead, no water may be used and instead another liquid such as DMSO or an oil may be used. The herbs may be formed into pills or capsules, or a syringe or an IV may be used. Any of the herbal combinations may be formed into a cream and rubbed onto the skin or hair, or a syringe may be used to inject a patient with an herbal combination.
In another example, the effect of CXCR4 antagonists on the survival of B4, HL60, Jurkat leukemic cells and HT29 colon cancer and prostate tumor cells was examined. Digoxin significantly inhibited the growth of leukemic cells at concentrations between (0.05-to 1 microgram/ml). Emodin by itself inhibited the growth of leukemic cells only at concentrations of more than 5microgrm/ml. Combinations of digoxin at concentrations of 0.1 microgram/ml and either 5 or 10 microgram /ml of emodin increased significantly the tumor killing ability of both compounds. Digoxin, Emodin, and their combination also add partial however significant effect on HT29 tumor cells. Certain treatments may be prepared as a mixture of herbs that are known to have separately certain molecular components or medicinal advantages. For example, emodin may be extracted from traditional medicinal plants such as Rhei Rhizoma and Rheum Palmatum. In one embodiment, the source of Emodin used is Da Huang-Chinese name, or Rhubarb Root-English name, or Rheum Plamatum-Botanical name, or Radix Rhisoma Rhei-Pharmaceutical name. Emodin may be extracted from Rhubarb, Buckthorn and/or Japanese Knotweed (Fallopia
Japonica). Aloe-emodin may be used which is a variety of emodin found in Socotrine, Barbados, and Zanzibar aloes.
A medicinal treatment is prepared in certain embodiments by mixing the herb, Da Huang, in water at a ratio of approximately 10: 1. The herb may be ground to a fine powder. The water may be added to the fine powdered herb, and the pot covered. After boiling, the heat is lowered in certain embodiments to about 70 degrees centigrade. The aqueous mixture is cooked for another hour. The liquid is then strained into a container. In some cases, this may be done twice. In the second cooking, the ratio may be reduced to 7.5: 1. The second cooking may take about 45 minutes including the boiling. Other herbs including Sheng Di Huang and/or Jin Yin Hua may be mixed with the Da Huang or prepared alone or in combination with other herbs. Dry or lipidized capsules, or a cream, or a topical injection solution, or an IV solution, or other formulations understood to those skilled in the art may also be provided for administration of the treatment. The methotrexate or other known or described or discovered treatment that is administered before during and/or after the herbal medicinal treatment in accordance with certain embodiments may also be prepared in multiple ways as understood by those skilled in the art.
Single herbs or combinations of two or more herbs alone or with any one or more of the described molecules may be prepared in a process involving the following or a subset or variation thereof: grinding the herbs to a fine texture in the mixer for around 2-3 min until it looked fine powder; weighing the powder (e.g., 25 gm) and transferring to a beaker (e.g., 2000 ml); adding distilled water (RT) to powdered herbs in a ratio of 1 :20 (gm of herbs: ml of water) and soaking the herbs for 15-20 min; boiling the mixture to 85-90° C; cooling the temperature of the mixture down to 70-75C after removing it from the hot plate; covering the beaker properly with aluminum paper and cooking the mixture at 70°C on hot plate-the total time of cooking of the mixture may be approximately 60 min which includes boiling, cooling it down and cooking; straining the mixture with the help of a manual strainer; after filtration, centrifuging the extract at 5000 rpm for 15 min and collecting the supernatant; filter sterilizing the supernatant by passing through 0.2 μπι syringe filter; storing the clear filtrate at 4°C-subsequent dilutions may be prepared. EXAMPLE NANOGEL/NANO-P ARTICULATE TOPICAL FORMULATION
An example nanogel formulation may include 1-20%, or or 1-15%, 1-10%, or 2.5-10% or 2.5-5% or approximately 2.5% or approximately 5% of an herbal mixture that includes Da Huang, Sheng Di Huang or Jin Yin Hua or combinations thereof. An example nanogel formulation in accordance with certain embodiments may include fulvic acid, e.g., up to 1-10% or 2.5-10% or 2.5-5% or 1-5% or 5-10%.
An example nanogel or nano-particulate lotion, cream, ointment or shampoo formulation may include carbopol ultraze 21/polymer surfactant. Triethanolomine may be advantageously used to convert lotion to gel and/or to neutralize a level of ph to between 5-8, 5.5-7.5 or 6-7 for topical application.
Propylene glycol and/or polyethylene glycol may be included in a nanogel or other nano- particulate topical formulation, e.g., each 0%-15% each or 5%-10% each, or up to 15% total, or up to 20%) total or up to a concentration level wherein spreadability may begin to become too low depending on other ingredients and topical administration considerations.
An example nanogel or other nano-particulate topical formulation may include DMDM Hydantoin.
A nano-liquid carrier may be included in a nano-particulate topical formulation in accordance with certain embodiments, e.g., stearic acid. The nano-particulate topical formulation may be lyophilized and homogenized with a dyno-mill, not exceeding a lipid limit, in an example embodiment.
Certain embodiments specifically do not include any parabins nor benzoid, as these have been deemed capable of effecting long term toxicity issues in certain patients or in a certain percentage of patients.
Hydrophyllic capacity is advantageously taken into account in certain embodiments such that permeability is greatly enhanced in a nanogel or other nano-particulate topical formulation including less than 450 nm particulates.
An example nano-particulate tablet formulation may include piperine, e.g., 1-10% or 2.5- 10%, or 5-10% or 1-5% or 2.5-5%. A tablet formulation may be hardened above 40°C-50°C. A nano-particulate tablet formulation may be reduced in size for ease of oral administration due to the enhanced permeability of nano-particulates compared with larger particulate sizes, e.g., above 450 nm. The permeability may be increased, e.g., from 10-20% to 20-80% or 30-70% or 40-60% or 50-60%) and nano-particulates in accordance with certain embodiments advantageously may be packed stably into tablets of smaller sizes. A nanogel or other nano-particulate topical formulation may include 1-20% or 1-15% or 1- 10%) or 2.5-10%) or 2.5%>-5%> of the nano-particulate mixture. Nano-particulates may be 150- 450nm or 150-350nm or 150-250nm, or 100-300nm or 100-400nm or 100-450nm or 50-450nm, which serve to administer more of the medicine or medicinal supplement to a patient than the 10- 20%) permeability or lower of example formulations having 450nm and above particulate sizes, because of reduced cumulative dose toxicities, better stability, and enhancement of treatment for the patient regarding tolerance and saturation issues.
A nano-emulsion, which tends to be oily, may include lOOnm or less particulate sizes.
A method of treating a skin or scalp condition in accordance with certain embodiments may include applying to the skin or scalp a medicinal composition formulated as a shampoo, conditioner, cream, ointment or other topical scalp or hair treatment that comprises a low concentration formula 5-10 grams or more of an active herbal combination of Sheng Di Huang, Da Huang and Jin Yin Hua in an example 16 fluid ounce formulation. A high concentration formula may include 50-150 grams of the active herbal combination in an example 16 fluid ounce formulation. A medium concentration formula may include 10-50 grams of the active herbal combination in an example 16 fluid ounce formulation.
In certain embodiments, the medicinal composition may include l%>-20%> of the active herbal combination. In certain embodiments, the medicinal composition may include 2.5%-10% of the active herbal combination. In certain embodiments, the medicinal composition may include 2.5%>-5.0%> of the active herbal combination. In certain embodiments, the medicinal composition may include 3.5wt.%> or more of Da Huang. In certain embodiments, the medicinal composition may include 15.4wt.%> or more of a combination of Da Huang and Sheng Di Huang.
In certain embodiments, the herbal combination may include 2-20 grams of Jin Yin Hua, 2-20 grams of Da Huang and 6-60 grams of Sheng Di Huang. In certain embodiments, the medicinal composition may include 0.2wt.%-4wt.% of Jin Yin Hua, 0.2wt.%-4wt.% of Da Huang, and 0.6wt.%-12wt.% of Sheng Di Huang.
In certain embodiments, the herbal combination may include 13.3 -60 grams of Sheng Di Huang, 3.3-15 grams of Da Huang, and 3.3-15 grams of Jin Yin Hua.
In certain embodiments, the combination of Sheng Di Huang, Da Huang and Jin Yin Hua comprises 20wt.%>-80wt.%> of the active herbal combination. For example, the active herbal combination may include 12wt.%-48wt.% of Sheng di Huang, 4wt.%-16wt.% of Da Huang and 4wt.%-16wt.% of Jin Yin Hua.
In one example, a shampoo formulation may include between 2.5wt.%-5.0wt.% of a combination of Sheng Di Huang, Da Huang and Jin Yin Hua. In another example, a shampoo formulation may include between 1.0wt.%-10.0wt.% of a combination of Sheng Di Huang, Da Huang and Jin Yin Hua.
In another example, a shampoo formulation may include between 1.0wt.%-15.0wt.% of a combination of Sheng Di Huang, Da Huang and Jin Yin Hua.
A treatment regimen may include combinations of applications of shampoo, cream and/or lotion to affected scalp or other skin areas.
While the invention has been described in terms of several embodiments, those skilled in the art will recognize that the invention is not limited to the embodiments described, but can be practiced with modification and alteration within the spirit and scope of the appended claims. The description is thus to be regarded as illustrative instead of limiting of the invention as set forth in the appended claims including structural and functional equivalents thereof.

Claims

We claim:
1. A medical kit for diagnosing and treating an inflammatory or autoimmune skin disorder, comprising:
(a) a diagnostic test kit, including:
(i) one or more swabs, spatulas, brushes, pads or slides, or combinations thereof, for collecting skin samples;
(ii) a multiplex cytokine assay that is configured for measuring within the collected skin samples several different cytokine levels, including levels of IL-17, IL-23 and TNF-a, and
(iii) an indicator for providing a diagnostic result to a patient or practitioner that is based on comparing a combination of the levels of IL-17, IL-23 and TNF-α measured in the skin samples and a known correlations between said combination of levels of IL-17, IL-23 and TNF-a and an inflammatory or autoimmune skin disorder; and
(b) a medicinal nanogel or nano-particulate lotion, cream, ointment or shampoo that includes effective amounts of fulvic acid, carbopol ultraze 21/polymer surfactant and a dosage composition including a predetermined number of 20-160 mg/kg doses of a combination of Da Huang, Sheng Di Huang and Jin Yin Hua with an average particulate size that is less than 450 nm.
2. The medical kit of claim 1, wherein said skin samples comprise serum or sera from skin washings, liquid blood serum, keratinocytes or fibroblasts, or combinations thereof.
3. The medical kit of claim 1, wherein said several different measured cytokine levels further include a level of IL-6.
4. The medical kit of claim 1, wherein said several different measured cytokine levels further include a level of IL-8 or IFN-gamma or both.
5. The medical kit of claim 1, wherein said several different measured cytokine levels further include a level of MIP-1 -alpha or IP- 10 or both.
6. The medical kit of claim 1, wherein said several different measured cytokine levels further include a level of nitric oxide, PGE2, COX, or LOX or combinations thereof.
7. The medical kit of claim 1, wherein said several different measured cytokine levels further include a level of VEGF, EGF, or FGF or combinations thereof.
8. The medical kit of claim 1, wherein said several different measured cytokine levels further include a level of ICAM-1, VCAM-1, or E- selectin or combinations thereof.
9. The medical kit of claim 1, wherein said several different measured cytokine levels further include levels of IL-5 and IL-13.
10. The medical kit of claim 9, wherein said several different measured cytokine levels further include levels of IL-7, IL-13, GMCSF and MCP-1 or combinations thereof.
11. The medical kit of claim 10, wherein said several different measured cytokine levels further include level of IL-9.
12. The medical kit of claim 1, wherein said several different measured cytokine levels further include a level of IL-5, IL-7, IL-9, IL-13, GMCSF, or MCP-1 or combinations thereof.
13. The medical kit of claim 1, wherein said several different measured cytokine levels further include levels of glutathione (GSH), vitamin D, oxidised glutathione (GSSG),
malondialdehyde, lipid peroxidation, homocysteine, CRP, ESR, isoprostanes, IL-4 and IL-10.
14. The medical kit of claim 1, wherein said several different measured cytokine levels further include levels of one or more of IL-5, IL-13, IL-6, IL-7, IL-13, GMCSF, MCP-1, IL-9, IL- l-β, IL-l-RA, IL-8, IL-9, IL-10, IL-12, IL-19, IL-20, IL-22, IL-24, IL-26, eotaxin, FGF-β, G-CSF, IFN-γ, IP- 10, MIP-1, PDGFRB, MIP-1-β, RANTES, VEGF, JAK, JAK1, JAK3, MPO
(myeloperoxidase), p38kinase, BRAF, BRAF V599E, KRAS, EGFR, ALK, TRPV1, TRPA1, MRGPRA3, PAR2, mucunain or other proteases, chloroquine, pruritogen, cowhage, sapsaicin, ROS, RET. SK-Mel-2, HT-29, MCF-7, THP-1, DU-145, MOLT-4, THP-1, K562, HL-60, U937, PD-1, ICAM-1, VCAM-1, E-selectin, HACAT-THP-1, LYN, ABL, BTK, SYK, ZAP-70,
PI3KCD, AKT, HER-2, FLT-3, KIT, LCK, MAPKl, MEKl, PGE, PGE2, PGE2-E4,MMP, PI3K- δ, PIK3CD, PIK3R1 CCL3, CCL4, PLC, BCR, CD-5, CD-38, CD-19, CD-20, CD-79a, β2Μ, NO, LTB4, PLA2, or PDE4, OR A KINASE, E.G., AKTl (PKB ALPHA), ERBB2 (HER2), FLT3, MAPK1 (ERK2), PRKCA (PKC ALPHA), BRAF, BRAF V599E OR MAP2K1 (MEK1), or combinations thereof.
15. The medical kit of claim 1, further comprising a prognostic kit and a prognostic indicator, said prognostic kit comprising said multiplex cytokine assay or a separate assay and said prognostic indicator configured for providing a prognostic result to a patient or practitioner based on comparing said combination of the several different cytokine levels from skin samples collected before and after administering a prognostic regimen including a subset of said predetermined number of doses of said dosage composition contained within said medicinal nanogel or nano-particulate lotion, cream, ointment or shampoo.
16. The medical kit of claim 1, wherein said dosage composition comprises between 1.0wt.%-15wt.% of said medicinal nanogel or nano-particulate lotion, cream, ointment or shampoo.
17. The medical kit of claim 16, wherein said herbal combination of Da Huang, Sheng di Huang and Jin Yin Hua comprises 60wt.% or more of said dosage composition.
18. The medical kit of claim 1, wherein said herbal combination of Da Huang, Sheng di Huang and Jin Yin Hua comprises between 1.0wt.%-15wt.% of said medicinal nanogel or nano- particulate lotion, cream, ointment or shampoo.
19. The medical kit of claim 1, wherein said dosage composition of Da Huang, Sheng di Huang and Jin Yin Hua comprises between 2.5wt.%-5wt.% of said medicinal nanogel or nano- particulate lotion, cream, ointment or shampoo.
20. The medical kit of claim 19, wherein said herbal combination of Da Huang, Sheng di Huang and Jin Yin Hua comprises 60wt.% or more of said dosage composition.
21. The medical kit of claim 1, wherein said herbal combination of Da Huang, Sheng di Huang and Jin Yin Hua comprises between 2.5wt.%-5wt.% of said medicinal nanogel or nano- particulate lotion, cream, ointment or shampoo.
22. The medical kit of claim 1, comprising:
(a) a multiplex cytokine meter that is configured for measuring within the collected skin samples several different cytokine levels, including levels of IL-17, IL-23 and TNF-a, and computing a diagnostic result based on comparing a combination of the several different cytokine levels and stored diagnostic correlation data for said combination of cytokine levels and an inflammatory or autoimmune skin disorder; and
(b) a visual or audio indicator, display or communications interface, or combinations thereof, for providing said diagnostic result to a patient or practitioner.
23. The medical kit of claim 22, wherein said meter comprises one or more tangible digital storage media having stored thereon processor-readable code representing a diagnostic database that comprises data representing statistical correlations between levels of certain markers in certain types of bodily fluid samples and probabilities relating to manifestations of certain diseases within patients whose measured levels of said markers in extracted bodily fluid samples approximately match certain of said data, and
wherein said data is configured to be accessible by a processor, and
wherein said processor is programmed to perform a diagnostic method that comprises: comparing said measured levels of said markers within said extracted bodily fluid samples with said data, and
outputting a diagnostic result in accordance with an approximate match of said measured levels with said certain of said data.
24. The medical kit of claim 23, wherein said one or more tangible digital storage media further have stored thereon processor-readable code for programming said processor to perform said diagnostic method.
25. The medical kit of claim 22, wherein said meter comprises one or more tangible digital storage media having stored thereon processor-readable code representing a prognostic database that comprises data representing statistical correlations between levels of certain markers in certain types of bodily fluid samples and probabilities relating to expected efficacies of administering certain treatment regimens/medicines as a treatment for certain diseases for patients whose measured levels of said markers in extracted bodily fluid samples approximately match certain of said data, and
wherein said data is configured to be accessible by a processor, and wherein said processor is programmed to perform a prognostic method that comprises: comparing said measured levels of said markers within said extracted bodily fluid samples with said data, and
outputting a prognostic result in accordance with an approximate match of said measured levels with said certain of said data.
26. The medical kit of claim 25, wherein said one or more tangible digital storage media further have stored thereon processor-readable code for programming said processor to perform said prognostic method.
27. The medical kit of claim 22, wherein said meter comprises a computer program product including one or more tangible digital storage media having stored thereon code for programming a processor to perform a diagnostic method, wherein the method comprises:
comparing said measured levels of said markers within said extracted bodily fluid samples with said data, and
outputting a diagnostic result in accordance with an approximate match of said measured levels with said certain of said data.
28. The medical kit of claim 22, wherein the meter comprises a computer program product includes one or more tangible digital storage media having stored thereon code for programming a processor to perform a prognostic method, wherein the method comprises:
comparing said measured levels of said markers within said extracted bodily fluid samples with said data, and
outputting a prognostic result in accordance with an approximate match of said measured levels with said certain of said data.
29. The medical kit of claim 22, comprising a prognostic kit and a prognostic indicator, said prognostic kit comprising said multiplex cytokine meter or a separate meter configured for computing a prognostic result based on comparing said combination of the several different cytokine levels from skin samples collected before and after administering a prognostic regimen including a subset of said predetermined number of doses of said dosage composition contained within said medicinal nanogel or nano-particulate lotion, cream, ointment or shampoo, and said prognostic indicator comprises a visual or audio indicator, display or communications interface, or combinations thereof, for providing said prognostic result to a patient or practitioner.
PCT/US2017/039177 2016-06-29 2017-06-26 Prognostic and diagnostic methods and herbal therapies for treating dermatoses, autoimmune diseases and inflammatory ailments WO2018005308A1 (en)

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US15/197,745 US20170000837A1 (en) 2013-05-22 2016-06-29 Prognostic and Diagnostic Kits and Herbal Therapies for Treating Skin Conditions, Autoimmune Diseases, Inflammatory Ailments and Cancer
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