CA3112722A1

CA3112722A1 - Nutraceutical composition for management of coronavirus

Info

Publication number: CA3112722A1
Application number: CA3112722A
Authority: CA
Inventors: Mahir Abduldaim
Original assignee: Individual
Current assignee: Individual
Priority date: 2021-03-21
Filing date: 2021-03-21
Publication date: 2022-09-21

Abstract

A nutraceutical and method for treating viral infections comprising arachidonic acid, along with oregano, sage, sweet basil, holy basil, fennel, garlic, lemon balm, peppermint, rosemary, echinacea pururea, elderberry, licorice root, astralagus root, ginger, panax gingseng, dandelion, calendula, cat's claw and olive leaf.

Description

TITLE
NUTRACEUTICAL COMPOSITION FOR MANAGEMENT OF CORONAVIRUS
FIELD OF THE INVENTION
[0001] The present invention relates to a nutraceutical composition for treating and managing symptoms of respiratory illnesses caused by viruses, including the novel coronavirus that causes COVID-19.
SUMMARY

[0002] In one general embodiment, the present invention is a method of treating viral infections comprising administering a nutraceutical composition.

[0003] In another embodiment, the present invention is a nutraceutical composition.
BACKGROUND OF THE INVENTION

[0004] Several viruses are responsible for respiratory infections in humans, and in most cases people recover without requiring specific treatment or hospitalization. In some cases, there are already effective vaccines, such as the annual influenza vaccine.
Older individuals and those with comorbidities, such as chronic conditions and illnesses including hypertension, diabetes, kidney disease and cardiovascular disease, Date Recue/Date Received 2021-03-21 are often more susceptible to more severe complications, including pneumonia.

[0005] A novel coronavirus, designated SARS-CoV-2, was discovered in China in December 2019, which subsequently caused an international outbreak of a respiratory illness named coronavirus disease 2019 (COVID-19). The World Health Organization (WHO) declared COVID-19 a pandemic on March 11, 2020. In most cases, COVID-19 is an infectious disease that also causes only mild to moderate symptoms and most people recover at home. In approximately 10% of cases, COVID-19 is more severe progressive disease characterized by pneumonia, multi-organ failure, and death.

[0006] Adults over the age of 50 years with at least one medical comorbidity, such as diabetes, hypertension, COPD and cancer, are at a greater risk for poor physical and mental health outcomes. Studies in China and India, for example, have shown that patients with comorbidities are at a higher risk of severe COVID-19 disease progression and death compared to patients without any comorbidities, with hypertension and diabetes the most prevalent comorbidities. The higher the number of comorbidities, the higher the risk of severe COVID-19 disease.

[0007] Although a number of vaccines have been approved for use, and there have been advances in treating COVID-19, there are currently no specific efficacious agents that have been approved for the treatment of COVID-19 infections.

[0008] Access to the vaccines is not universal, particularly in less wealthy countries where national vaccine campaigns have not yet begun. Even in wealthy countries, vaccines are not yet consistently widely available. Finally, there are concerns Date Recue/Date Received 2021-03-21 that currently available vaccines may provide less protection against emerging variants of the COVID-19 virus.

[0009] Accordingly there is a need for safe, effective and accessible treatments for viral respiratory infections, including those caused by coronaviruses such as COVID-19.
DESCRIPTION

[0010] The nutraceutical composition disclosed herein comprises about 50 wt %
arachidonic acid. Optionally, the nutraceutical composition additionally comprises herbal ingredients, namely, oregano, sage, sweet basil, holy basil, fennel, garlic, lemon balm, peppermint, rosemary, echinacea pururea, elderberry, licorice root, astragalus root, ginger, panax ginseng, dandelion, calendula, cat's claw and olive leaf.

[0011] A nutraceutical is a bioactive compound occurring as a food component, additive, or product, including vitamins, dietary fiber, herbal extracts, carotenoids, and probiotics; nutraceuticals are said to promote health and well-being, allegedly helping in the prevention and treatment of disease.

[0012] Arachidonic acid is a long chain polyunsaturated fatty acid that is important for modulating the structure, fluidity and function of cell membranes, particularly in the nervous system, muscular system and immune system. The majority of arachidonic acid is stored in cell membranes, with the amount of free arachidonic acid generally low inside cells. Phospholipase A2 acts to release arachidonic acid from the cell membrane whereupon free arachidonic acid acts as a precursor for the Date Recue/Date Received 2021-03-21 biosynthesis of prostaglandins, thromboxanes and leukotrienes.

[0013] Humans typically obtain arachidonic acid from dietary sources such as meat and eggs. Arachidonic acid can also be synthesized from linoleic acid, which is abundant in vegetable oils, nuts and seeds. While the human body is able to synthesize arachidonic acid from linoleic acid, via fatty acid desaturase and elongase enzymes, it is appropriate to consider arachidonic acid an essential fatty acid, since the requirement for arachidonic acid appears to exceed endogenous synthesis under many circumstances, such as growth and inflammation.

[0014] Arachidonic acid supplementation has been studied in many contexts, including embryonic and infant development, building skeletal muscle, improving cognitive function, treating neurological and cardiovascular disease and modulating circadian rhythms.

[0015] It is also well known that polyunsaturated fatty acids, such as arachidonic acid exhibit antimicrobial, including anti-viral, activity, and it has been hypothesized that oral and intravenous administration of arachidonic acid may treat or prevent viral infections such as COVID-19. Significantly, arachidonic acid synthesis enzymes are often suppressed during viral infections. Additionally, arachidonic acid (both free and membrane-bound) are present in lower amounts during severe viral infections and sepsis.

[0016] Evidence suggests low concentrations of arachidonic acid play a prominent pro-inflammatory role, while at higher concentrations, arachidonic acid Date Recue/Date Received 2021-03-21 appears to play a large anti-inflammatory role that leads to the resolution of inflammation and repair. Arachidonic also plays a prominent anti-fibrotic function.

[0017] Arachadonic acid is generally recognized as safe (GRAS) by the Food and Drug Administration (FDA), and even very high doses are reported to be safe.
In one study, arachidonic acid was provided, at a dose of 1500 mg per day, to groups receiving the influenza vaccine. The post-immunization proliferation in response to influenza vaccine was about fourfold higher in the group receiving a high arachidonic acid diet compared to the group receiving a low arachidonic acid diet.

[0018] Accordingly, the formulation described below is expected to reduce inflammation and fibrosis, and will provide anti-viral activity with no major side effects, in cases of viral respiratory illnesses, including COVID-19.

[0019] Optionally, herbal ingredients may be added to arachidonic acid. The herbal ingredients listed herein were chosen based on their antioxidant, antiviral and anti-inflammatory properties, as well as ability to stimulate the immune system. Some of these herbs are also known to be useful in the management of diabetes and cardiac disorders.

[0020] The ingredients for the oral nutraceutical composition were obtained from known sources using methodologies known in the art.

[0021] In one embodiment, the nutraceutical is intended for daily administration with the total daily intake range of arachidonic acid 600-6000 mg.

Date Recue/Date Received 2021-03-21

[0022] In another embodiment, the nutraceutical composition is intended for daily administration with the the total daily intake ranges as follows: 600-6000 mg of arachidonic acid, 50-200mg of oregano, 50-200 mg of sage, 50-200 mg of sweet basil, 50-200 mg of holy basil, 50-200 mg of fennel, 20-100 mg of garlic, 50-200 mg of lemon balm, 10-100 mg of peppermint, 50-200 mg of rosemary, 50-200 mg of echinacea purpurea, 100-300 mg of elderberry "sambucus", 50-200 mg of licorice root, 50-200 mg of astralagus root, 10-100 mg of ginger, 10-100 mg of panax ginseng, 10-100 mg of dandelion, 10-100 mg of calendula, 10-100 mg of cat's claw, and 10-100 mg of olive leaf.

[0023] In another embodiment, the total daily intake is divided into conveniently-sized soft gels containing arachidonic acid in a total weight amount of about 1000 to 1200 mg. The total weight amount may be varied as long as the daily intake ranges between about 600-6000 mg.

[0024] In another embodiment, the total daily intake is divided into convenient soft gels containing a mixture of oregano, sage, sweet basil, holy basil, fennel, garlic, lemon balm, peppermint, rosemary, echinacea pururea, elderberry, licorice root, astralagus root, ginger, panax gingseng, dandelion, calendula, cat's claw, olive leaf and arachidonic acid in a total weight amount of about 1000 to 1200 mg. Each of the ingredients is provided in the following weight percentages: about 50% wt %
arachidonic acid, about 1-10 wt% oregano, about 1-10 wt% sage, about 1-10 wt%
sweet basil, about 1-10 wt% holy basil, about 1-10 wt% fennel, about 1-10 wt%
garlic, about 1-10 wt% lemon balm, about 1-10 wt% peppermint, about 1-10 wt% rosemary, about 1-wt% echinacea pururea, about 1-10 wt% elderberry, about 1-10 wt% licorice root, about Date Recue/Date Received 2021-03-21 1-10 wt% astralagus root, about 1-10 wt% ginger, about 1-10 wt% panax gingseng, about 1-10 wt% dandelion, about 1-10 wt% calendula, about 1-10 wt% cat's claw and about 1-wt% olive leaf.

[0025] In a preferred embodiment, each of the ingredients is provided in a 5 supplement in the following percentages: about 50 wt % arachidonic acid, about 3 wt %
oregano, about 3 wt % sage, about 3 wt % sweet basil, about 3 wt% holy basil, about 3 % fennel, about 1.5 wt% garlic, about 3 wt% lemon balm, about 1.5 wt%
peppermint, about 3 wt% rosemary, about 3 wt% echinacea pururea, about 6 wt% elderberry, about 3 wt% licorice root, about 3 wt% astralagus root, about 1.5 wt% ginger, about 1.5 wt%
10 panax gingseng, about 1.5 wt% dandelion, about 1.5 wt% calendula, about 1.5 wt% cat's claw and about 1.5 wt% olive leaf.

[0026] The nutraceutical composition can be formulated into pharmaceutically acceptable forms, and may be formulated into tablets, capsules, soft gels and suppositories as described above for example. The nutraceutical composition may also be formulated as a dietary supplement in the form of tablets, capsules, powders, syrups and teas, that may be mixed with other dietary liquids or foods such as milk, juice or water. Flavourings, binders and the like may be added as required.

[0027] The nutraceutical composition may be administered in accordance with the daily dose ranges indicated above by formulating the dose into multiple portions.
For example, in one embodiment, the intended dose range is divided into two to ten soft gels a day. In the trial described below, the nutraceutical composition comprising arachidonic acid, oregano, sage, sweet basil, holy basil, fennel, garlic, lemon balm, Date Recue/Date Received 2021-03-21 peppermint, rosemary, echinacea pururea, elderberry, licorice root, astragalus root, ginger, panax ginseng, dandelion, calendula, cat's claw and olive leaf, was administered as three soft gels taken twice daily, which was effective in managing COVID-19 symptoms in asymptomatic and mildly symptomatic subjects. For more severe cases of COVID-19, the nutraceutical composition can be administered as six soft gels followed by up to four soft gels later in the same day.

[0028] The nutraceutical composition described herein has been demonstrated to be safe and effective at managing asymptomatic and mildly symptomatic COVID-19 in older patients with comorbidities. In a double blind study, 118 subjects were treated with the nutraceutical composition or a placebo. Subjects were instructed to take 3 gel capsules of either the nutraceutical composition or the placebo twice a day for 14 days.
The study included both male and female subjects, 50 years and older, with chronic stable medical conditions that are under treatment and controlled by medication (diabetes mellitus, hypertension or chronic heart disease). The subjects must not have been diagnosed more than 2 days prior to enrolling in the study, as assessed by a positive oropharyngeal/nasal swab RT-PCR for Sars-Co-V2. Finally the subjects were either asympomatic or exhibited mild syptoms (cough, weakness, sore throat, low grade fever no more than 38.5 C) with onset of symptoms no more than 4 days prior to enrollment. To be considered mild symptoms, the respiratory rate was not more than .. 22 breaths per minute, resting 5p02 >95%, normal highly sensitive C-reactive protein (HS-CRP) (<10mg/L) and no signs of dehydration, sepsis or shortness of breath.

[0029] Subjects were administered with three soft gels, to be taken orally, containing the nutraceutical composition or the placebo twice a day, for 14 days. This Date Recue/Date Received 2021-03-21 frequency was expected to be safe and well tolerated, based on previous documented use of these herbs in humans at significantly higher doses.

[0030] To assess the safety and efficacy, physical and vital signs were scored according to the NEWS Score and the 7 point ordinal scale, at Visit 1 (Screening), Visit 2 (Day 1), Visit 3 (Day 7) and Visit 4 (Day 15). The NEWS Score and 7 point ordinal scale are standard practice in medicine to measure a disease severity for triage, follow up, and research purposes. The scores were obtained after full clinical assessment that included a blood pressure, heart rate/pulse rate/ oxygen saturation or 5p02 (pulse oximetry), temperature and respiratory rate.

[0031] At Screening, 89.8% of the cases in the nutraceutical composition group had a NEWS score of 3 which was comparable to 83.1% of the cases amongst the placebo group, which was not statistically significant. By the end of the 7th day, the results showed a statisticlly significant difference between the treatment groups. 74.6%
of subjects treated with the nutraceutical composition had a NEWS score of 0 at the end of 7th day compared to 49.2% of subjects treated with the placebo.

[0032] Similar results were obtained when the subjects were assessed on the 7 point ordinal scale. 76.3% of subjects treated with the nutraceutical composition had a score of 1 at the end of 7th day. In comparison, 47% of subjects treated with the placebo had a score of 1.

[0033] In addition, the nutraceutical composition reduced the duration of infection. Trial participants provided with the nutraceutical composition tested Date Recue/Date Received 2021-03-21 negative for the SARS-CO-V2 virus (PCR test) 1.5 days earlier than participants provided with the placebo.

[0034] This study demonstrates that subjects treated for the management of COVID-19 symptoms with the nutraceutical composition showed significantly better results than when treated with the placebo. The results indicate the nutraceutical composition is safe and effective for preventing the progression to severe disease. It is expected that the nutraceutical composition will be an effective treatment for other viral respiratory illnesses.
Date Recue/Date Received 2021-03-21

Claims

What is claimed is:

1. A nutraceutical composition for treating viral infections comprising arachidonic acid.

2. The nutraceutical composition of claim 1 formulated into a pharmaceutical composition.

3. The nutraceutical composition of claim 2 formulated into any one of a tablet, soft gel and capsule.

4. The nutraceutical composition of claim 1 formulated into a component of a prepared food product.

5. The nutraceutical composition of claim 1 for use in treating COVID-19.

6. The nutraceutical composition of claim 1 comprising at least 50% wt arachidonic acid.

7. A nutraceutical for treating viral infections comprising:
arachidonic acid, oregano, sage, sweet basil, holy basil, fennel, garlic, lemon balm, peppermint, rosemary, echinacea pururea, elderberry, licorice root, astralagus root, ginger, panax gingseng, dandelion, calendula, cat's claw and olive leaf.

Date Recue/Date Received 2021-03-21

8. The nutraceutical of claim 7 formulated into a pharmaceutical composition.

9. The nutraceutical composition of claim 8 formulated into any one of a tablet, soft gel and capsule.

10. The nutraceutical composition of claim 7 formulated into a component of a prepared food product.

11. The nutraceutical composition of claim 7 for use in treating COVID-19.

12. The nutraceutical composition of claim 7 comprising about 50% wt %
arachidonic acid, about 1-10 wt% oregano, about 1-10 wt% sage, about 1-10 wt%
sweet basil, about 1-10 wt% holy basil, about 1-10 wt% fennel, about 1-10 wt%
garlic, about 1-10 wt% lemon balm, about 1-10 wt% peppermint, about 1-10 wt% rosemary, about 1-wt% echinacea pururea, about 1-10 wt% elderberry, about 1-10 wt% licorice root, about 1-10 wt% astralagus root, about 1-10 wt% ginger, about 1-10 wt% panax gingseng, about 1-10 wt% dandelion, about 1-10 wt% calendula, about 1-10 wt% cat's claw and about 1-10 wt% olive leaf.

13. The nutraceutical composition of claim 12 comprising about 50 wt %
arachidonic acid, about 3 wt % oregano, about 3 wt % sage, about 3 wt % sweet basil, about 3 wt%
holy basil, about 3 % fennel, about 1.5 wt% garlic, about 3 wt% lemon balm, about 1.5 wt% peppermint, about 3 wt% rosemary, about 3 wt% echinacea pururea, about 6 wt%
elderberry, about 3 wt% licorice root, about 3 wt% astralagus root, about 1.5 wt%

Date Recue/Date Received 2021-03-21 ginger, about 1.5 wt% panax gingseng, about 1.5 wt% dandelion, about 1.5 wt%
calendula, about 1.5 wt% cat's claw and about 1.5 wt% olive leaf.

14. Use of a nutraceutical composition comprising arachidonic acid, oregano, sage, sweet basil, holy basil, fennel, garlic, lemon balm, peppermint, rosemary, echinacea pururea, elderberry, licorice root, astralagus root, ginger, panax gingseng, dandelion, calendula, cat's claw and olive leaf as an antiviral agent.

15. Use of a nutraceutical composition comprising arachidonic acid as an antiviral agent.

16. Use according to one of claim 14 and 15 to treat viral respiratory infections.

17. Use according to claim 16 wherein the viral respiratory infection is caused by a coronoavirus.

18. Use according to claim 17 wherein the coronavirus is SARS-CoV-2.

19. A method of treating viral infections, said method comprising administering a nutraceutical composition comprising arachidonic acid, oregano, sage, sweet basil, holy basil, fennel, garlic, lemon balm, peppermint, rosemary, echinacea pururea, elderberry, licorice root, astralagus root, ginger, panax gingseng, dandelion, calendula, cat's claw and olive leaf, on a daily basis.

. The method of claim 19 wherein the nutraceutical composition is formulated into Date Recue/Date Received 2021-03-21 either of a pharmaceutical composition and a component of a prepared food product.

21. The method of claim 19 wherein the viral infection is caused by a coronovirus.

22. The method of claim 21 wherein the coronavirus is SARS-CoV-2.

23. The method of claim 19 wherein the nutraceutical composition is administered to a total daily dose of 50 to 200mg of oregano, 50 to 200 mg of sage, 50 to 200 mg of sweet basil, 50 to 200 mg of holy basil, 50 to 200 mg of fennel, 20 to 100 mg of garlic, 50 to 200 mg of lemon balm, 10 to 100 mg of peppermint, 50 to 200 mg of rosemary, 50 to 200 mg of echinacea purpurea, 100 to 300 mg of elderberry "sambucus", 50 to 200 mg of licorice root, 50 to 200 mg of astralagus root, 10 to 100 mg of ginger, 10 to 100 mg of panax ginseng, 10 to 100 mg of dandelion, 10 to 100 mg of calendula, 10 to 100 mg of cat's claw, 10 to 100 mg of olive leaf, and 600 to 6000 mg of arachidonic acid.

24. Use of a nutraceutical composition comprising arachidonic acid, oregano, sage, sweet basil, holy basil, fennel, garlic, lemon balm, peppermint, rosemary, echinacea pururea, elderberry, licorice root, astralagus root, ginger, panax gingseng, dandelion, calendula, cat's claw and olive leaf to strengthen immune system function.

25. A method of supplementing the dietary needs of individuals suffering from a viral infection, said method comprising administering a nutraceutical composition comprising arachidonic acid, oregano, sage, sweet basil, holy basil, fennel, garlic, lemon balm, peppermint, rosemary, echinacea pururea, elderberry, licorice root, astralagus root, ginger, panax gingseng, dandelion, calendula, cat's claw and olive leaf, on a daily Date Recue/Date Received 2021-03-21 basis.

26. The method of claim 25 wherein the nutraceutical composition is administered to a total daily dose of 50 to 200mg of oregano, 50 to 200 mg of sage, 50 to 200 mg of sweet basil, 50 to 200 mg of holy basil, 50 to 200 mg of fennel, 20 to 100 mg of garlic, 50 to 200 .. mg of lemon balm, 10 to 100 mg of peppermint, 50 to 200 mg of rosemary, 50 to 200 mg of echinacea purpurea, 100 to 300 mg of elderberry "sambucus", 50 to 200 mg of licorice root, 50 to 200 mg of astralagus root, 10 to 100 mg of ginger, 10 to 100 mg of panax ginseng, 10 to 100 mg of dandelion, 10 to 100 mg of calendula, 10 to 100 mg of cat's claw, to 100 mg of olive leaf, and 600 to 6000 mg of arachidonic acid.

10 27. The method of claim 25 wherein the viral infection is caused by a coronavirus.

28. The method of claim 27 wherein the coronavirus is SARS-CoV-2.

29. A pharmaceutical composition for treating viral infections comprising:
arachidonic acid, oregano, sage, sweet basil, holy basil, fennel, garlic, lemon balm, peppermint, rosemary, echinacea pururea, elderberry, licorice root, astralagus root, ginger, panax gingseng, dandelion, calendula, cat's claw and olive leaf.

30. The pharmaceutical composition of claim 29 comprising about 50 wt %
arachidonic acid, about 1-10 wt% oregano, about 1-10 wt% sage, about 1-10 wt%
sweet basil, about 1-10 wt% holy basil, about 1-10 wt% fennel, about 1-10 wt%
garlic, about 1-10 wt% lemon balm, about 1-10 wt% peppermint, about 1-10 wt% rosemary, about 1-.. wt% echinacea pururea, about 1-10 wt% elderberry, about 1-10 wt% licorice root, about Date Recue/Date Received 2021-03-21 1-10 wt% astralagus root, about 1-10 wt% ginger, about 1-10 wt% panax gingseng, about 1-10 wt% dandelion, about 1-10 wt% calendula, about 1-10 wt% cat's claw and about 1-wt% olive leaf.

31. The pharmaceutical composition of claim 30 comprising about 50 wt %
5 arachidonic acid, about 3 wt % oregano, about 3 wt % sage, about 3 wt %
sweet basil, about 3 wt% holy basil, about 3 % fennel, about 1.5 wt% garlic, about 3 wt%
lemon balm, about 1.5 wt% peppermint, about 3 wt% rosemary, about 3 wt% echinacea pururea, about 6 wt% elderberry, about 3 wt% licorice root, about 3 wt%
astralagus root, about 1.5 wt% ginger, about 1.5 wt% panax gingseng, about 1.5 wt%
dandelion, 10 about 1.5 wt% calendula, about 1.5 wt% cat's claw and about 1.5 wt%
olive leaf.

32. The pharmaceutical composition of claim 29 formulated into any one of a tablet, soft gel, capsule and suppository.

33. The pharmaceutical composition of claim 29 wherein the viral infections are caused by coronoavirus.

34. The pharmaceutical composition of claim 33 wherein the coronavirus is SARS-CoV-2.

35. A dietary supplement for treating viral infections comprising:
arachidonic acid, oregano, sage, sweet basil, holy basil, fennel, garlic, lemon balm, peppermint, rosemary, echinacea pururea, elderberry, licorice root, astralagus root, ginger, panax gingseng, dandelion, calendula, cat's claw and olive leaf.

Date Recue/Date Received 2021-03-21

36. The dietary supplement of claim 35 comprising about 50 wt % arachidonic acid, about 1-10 wt% oregano, about 1-10 wt% sage, about 1-10 wt% sweet basil, about wt% holy basil, about 1-10 wt% fennel, about 1-10 wt% garlic, about 1-10 wt%
lemon balm, about 1-10 wt% peppermint, about 1-10 wt% rosemary, about 1-10 wt%
echinacea .. pururea, about 1-10 wt% elderberry, about 1-10 wt% licorice root, about 1-10 wt%
astralagus root, about 1-10 wt% ginger, about 1-10 wt% panax gingseng, about 1-10 wt%
dandelion, about 1-10 wt% calendula, about 1-10 wt% cat's claw and about 1-10 wt%
olive leaf.

37. The dietary supplement of claim 36 comprising about 50 wt % arachidonic acid, about 3 wt % oregano, about 3 wt % sage, about 3 wt % sweet basil, about 3 wt%
holy basil, about 3 % fennel, about 1.5 wt% garlic, about 3 wt% lemon balm, about 1.5 wt%
peppermint, about 3 wt% rosemary, about 3 wt% echinacea pururea, about 6 wt%
elderberry, about 3 wt% licorice root, about 3 wt% astralagus root, about 1.5 wt%
ginger, about 1.5 wt% panax gingseng, about 1.5 wt% dandelion, about 1.5 wt%
calendula, about 1.5 wt% cat's claw and about 1.5 wt% olive leaf.

38. The dietary supplement of claim 35 wherein the viral infections are caused by coronoavirus.

39. The dietary supplement of claim 38 wherein the coronavirus is SARS-CoV-2.

40. A method of strengthening the immune system in an individual, said method comprising administering a nutraceutical composition comprising arachidonic acid.

Date Recue/Date Received 2021-03-21

41. The method of claim 40 wherein the nutraceutical is administered to a total daily does of 600 to 6000 mg of arachidonic acid.

42. The method of claim 40, wherein the nutraceutical composition is additionally comprised of oregano, sage, sweet basil, holy basil, fennel, garlic, lemon balm, peppermint, rosemary, echinacea pururea, elderberry, licorice root, astralagus root, ginger, panax gingseng, dandelion, calendula, cat's claw and olive leaf.

43. The method of claim 42 wherein the nutraceutical composition is administered to a total daily dose of 50 to 200 mg of oregano, 50 to 200 mg of sage, 50 to 200 mg of sweet basil, 50 to 200 mg of holy basil, 50 to 200 mg of fennel, 20 to 100 mg of garlic, 50 to 200 mg of lemon balm, 10 to 100 mg of peppermint, 50 to 200 mg of rosemary, 50 to 200 mg of echinacea purpurea, 100 to 300 mg of elderberry "sambucus", 50 to 200 mg of licorice root, 50 to 200 mg of astralagus root, 10 to 100 mg of ginger, 10 to 100 mg of panax ginseng, 10 to 100 mg of dandelion, 10 to 100 mg of calendula, 10 to 100 mg of cat's claw, 10 to 100 mg of olive leaf, and 600 to 6000 mg of arachidonic acid.

Date Recue/Date Received 2021-03-21