BAMS A Resource Person for ayurveda courses importance in current era

General knowledge

1. BAMS – A Resource Person (Bridge between Ayurveda and Modern Sciences) Presented by Vaidya Balendu Prakash , BAMS ( Ayurvedacharya ) Padmashree Awardee (Year 1999) VCPC Research Foundation, Uttarakhand 9837028544, [email protected]

2. Opportunity India is the only country in the world where different systems of medicines like Ayurveda , Unani , Siddha , Homeopathy and Naturopathy are officially recognized as independent Medical systems in conjunction with Western medicine ( Allopathy )

3. Unique feature Registered practitioners of Ayurveda and Unani can prepare medicines for use in their respective clinical practices without obtaining manufacturing license Integrated system of education and research Blending of modern diagnostics with traditional knowledge Scope for documentation (GCP guidelines)

4. Background Grown up with the tradition of Rasa-Shastra – the glorified science of Ayurveda Deals with therapeutics of Mercury and metals for the treatment of aging and incurable diseases Witnessed miraculous cure of certain types of cancer and chronic diseases with failures as well Consolidated data of manufacturing and clinical practice of my father Batch to batch variation was one of the biggest hindrance at that time

5. Mission Statement To bring the stated efficacy of Ayurveda into main stream medicine Pathway – Positivism (19th century model of Comte)

6. Positivism: A scientific approach Observation Hypothesis Penicillin, Nitrous oxide, magnet Theory Drug discovery: 15 years, $ 1.8 billion

7. Acute Promyelocytic Leukemia A fatal type of blood cancer with high morbidity Silver based formulation brought miraculous recovery to a de novo patient in year 1982 (still alive) Many more such successes in de novo and relapsed cases of APML till 1996 The findings were evaluated by four independent fact finding committees set up by the then MOH&FW, GOI (1961, 1983, 1988, 1996) Pilot study sanctioned by CCRAS, Department of ISM&H, MOH&FW, GOI to treat 15 cases of APML

8. Methodology and Result Constitution of Cancer Research Committee Reference laboratory: IRCH, AIIMS, New Delhi Enrolment: 15 cases (8 relapse, 7 de novo ) Diagnostics: Bone Marrow Aspiration, Blood Test Treatment: Navjeevan and Kamdudha + Blood transfusion and Antibiotics, if required, no conventional treatment for Leukemia Findings: 4 patients died on Day 3, 7, 11 and 28; 11 completed 90 days treatment and achieved complete remission. No Grade II toxicity. Followed up for 4 years Drug development under CCRAS, Ministry of AYUSH Accorded US and European patent through NRDC, GOI

9. Indo US workshop on Ayurveda and Cancer held at New Delhi under the aegis of Ministry of AYUSH, GOI; 3 rd - 4 th March, 2016 Ayurveda Development Therapeutics Program (ADTP) on Cancer by AYUSH Ministry, NCI India and NCI USA; India International Centre, New Delhi, 18 th December, 2018 Prakash BV, Parikh PM, Pal SK, Herbo -mineral Ayurvedic Treatment in a High Risk Acute Promyelocytic Leukaemia Patient With Second Relapse: 12 years follow up; Journal of Ayurveda & Integrative Medicine, Vol. 1. (3), pp. 215-218, July- September, 2010 Balendu Prakash , Shikha Prakash , Shakshi Sharma, Sneha Tiwari , Remission in a Relapse Case of Acute Promyelocytic Leukaemia for Twenty-two years using Metal Based Ayurvedic Treatment: A Case Report, Journal of Ayurveda Case Reports, 2019, 2(2), 3-8. Citations and Publications

10. Refractory & Chronic Migraine Most common form of headache Affects nearly 220 million people in the world Disease of urban society Incidences are more in developed countries WHO rank 7 th among debility causing diseases (Shift from 19 th to 7 th ranking in fifteen years) Mostly affects productive age group the most (18 – 45); more women than men (3:1 ratio)

11. How to Diagnose Migraine? There is no pathology or image examinations to diagnose migraine Such investigations are made to rule out other causes The current diagnosis of migraine is based on a personal interview of the subject following IHS diagnostic criteria (Dowson AJ et at, International Headache Society Criteria, Curr Med Res Opin , 2004; 20(7): 1125-1135)

12. Ayurvedic Treatment Protocol (ATP) Regulated diet (3 meals + 3 snacks) 1600 calories / day Eight hour sleep Combination of five classical Ayurvedic Formulations (Herbo – minerals) Narikel Lavana NUMAX Rason Vati Godanti Mishran

13. Desperate attempt by a chronic migraineur >20 years Logical intervention and structuring of prescription Miraculous and speedy recovery with repeated results Thirty two years long journey starting from Retrospective           Prospective         Safety         Pharmacological         Randomized Clinical Trial Genesis of Ayurvedic Treatment        

14. - 16 th Migraine Trust International Symposium, London, September 2006, Cephalalgia 2006; 26(11), 1367 - 13th International Congress on Headache, Sweden, June 2007 Cephalalgia, 2007; 27, 745 - 52nd Meeting of the American Headache Society, June 2010, USA, Headache 2010; 50 (Suppl 1): 53 - Response to Ayurvedic therapy in the treatment of Migraine without Aura, Int J of Ay Research 2010 ; 1(1):30-36 - The case studies on prophylactic ayurvedic treatment in migraine patients. Int J of Genuine Traditional Medicine 2012 ; 2:17 Publications

15. Principle Investigator:  Prof (Dr) Manjari Tripathi (PI) Institute: Department of Neurology,  AIIMS, New Delhi                                              Co-investigators: Prof (Dr) A K Mahapatra & Vaidya Balendu Prakash                                      Study period: April 1, 2012 to May 31, 2016 Total number of patients: 154 Groups: 2; Uniform Ayurvedic Rx and varied conventional prophylactic Rx Funding Agency: Ipca Laboratories Limited, Mumbai Randomised controlled clinical trial to evaluate prophylactic properties of ayurvedic treatment protocol in refractory and chronic migraine patients

16. “Ayurvedic Treatment Protocol comprising four herbo-mineral formulations along with regulated diet and life-style was well tolerated by the patients without any adverse events. The observation of study indicated that Ayurveda has significant and sustainable effect in the prevention of migraine. ” Signed by Prof (Dr) Manjari Tripathi Outcome of Clinical Trial

17. Nutritional Anemia Most common form of anemia resulting from inadequate intake or assimilation of materials essential for the production of red blood cells and hemoglobin NUMAX - a modified form of Sootshekhar Rasa and Sitopaladi Churna brings significant and sustainable relief in Nutritional Anemia in comparison to Iron Folic Acid (IFA) by enhancing iron absorption

18. Ayurveda and Anemia: Study I First pilot study, sponsored by Dept. of Women &Child Welfare, GOI, New Delhi 600 anemic women of reproductive age group (11–45) Group Medicine Dosage Subjects Duration 1; Control Diet + Starch 120 90 days 2 Diet + IFA 1 OD 120 90 days 3 Diet + Ayas 1 BD 120 90 days 4 Diet + SS 1 BD 120 90 days 5 Diet + Ayas +SS 1 BD 120 90 days SS- 125 mg Sootshekhar & 500 mg Sitopaladi; IFA- 100 mg of elemental iron and 500 mg of folic acid

19. Ind. J. Hemat & Blood Transfusion. 2000:18: 4; 79-83 Starch SS IFA Ayas Ayas + SS 1.1 1.8 1.6 1.5 0.3 The group which was given Ayas + SS showed the best results (1.8) Result: Study I

20. Significant and sustainable effect of NIAF in the treatment of adolescent anemia (n=1500) Sponsored by Ipca laboratories ltd., Mumbai SS- 125 mg Sootshekhar & 500 mg Sitopaladi ; SSD-250 mg Sootshekhar & 1000 mg Sitopaladi ; IFA- 100 mg of elemental iron and 500 mg of folic acid Group Medicine Dosage Subjects Duration Control Starch 300 90 days 2 SS 1 OD 300 90 days 3 SSD 1 OD 300 90 days 4 SSD Weekly 300 90 days 5 IFA 1 OD 300 90 days Study II

21. The J. of Alt & Comp Medicine. 2010:16: 2; 205-211 The group which was given SSD had the best results (0.69) 0.07 0.20 0.69 0.04 0.40 Starch SS IFA SSD SSDw - 0.03 0.10 0.01 0.03 0.11 Result: Study II

22. Integration of Ayurvedic formulations with IFA in the treatment of nutritional anaemia among school going adolescents of Dehradun District Sponsored by Dept. of AYUSH, Ministry of H & FW, GOUK 820 anemic students (11-18 years) Group Medicine Dosage Subjects Duration Control Starch 205 90 days 2 SS 1 OD 205 90 days 3 IFA 1 OD 205 90 days 4 IFA + SS 1 OD 205 90 days SS- 250 mg Soothsekhar & 400 mg Sitopaladi; IFA- 100 mg of elemental iron and 500 mg of folic acid Study III

23. Int J of Genuine Traditional Medicine, Vol. 6(1) / e5, 2016 Significant improvement was noted in the group given SS + IFA (1.21) 1.21 0.32 0.7 - 0.03 - 0.15 - 0.17 - 0.18 0.02 Starch SS IFA SS + IFA Result: Study III

24. Results At A Glance Non Iron containing Ayurvedic Formulation (NIAF) (SR 250mg + SC 400mg) has significant and sustainable effect in improvement of Nutritional Anemia NIAF along with IFA shows synergistic effect in reducing Nutritional Anemia by significantly enhancing absorption and effect of IFA

25. Allergic Rhinitis Inflammation of the nasal mucosa caused due to exposure to allergens Most common allergens are animal dander, pollen, dust, dust mites, molds and mildew, latex, poisonous plants, nuts, shellfish, bee sting, change of place or season, or certain medications and chemicals

26. Symptoms and Diagnosis Diagnosis* (presence of minimum two out of the following seven symptoms) : 1. Sneezing 2. Itchy nose 3. Itchy palate 4. Rhinorrhea 5. Nasal congestion 6. Conjunctival hyperemia 7. Watering of eyes *ARIA criteria (Allergic Rhinitis and its Impact on Asthma)

27. Ayurvedic Perspective Allergic Rhinitis – Pratishyay; a Kapha dominant disorder of n asa shoth Cause – Madhur, Guru, Snigdha, Sheet dravyas Treatment – Tikta, Kashay, Katu, Laghu, Ruksha, Ushna & shothaghna dravya

28. Genesis of IMMBO It all started with myself in the autumn of 1997 Classical formulations such as S anjeevani, Kaphaketu, L axmivilas, Sitopaladi, Trikatu tadi Kwath, Unnavadi Kwath, Mrityunjay Rasa, Swarnvasant Malti had limited effects Allopathic antibiotics, anti-allergics and steroids brought effect for a week only Homeopathy worked for a day but caused severe adverse effects The desperate situation laid the foundation of the present formulation which could bring instant and sustainable relief

29. Formula of the Formulation Cedrus deodara, Curcuma longa, Cypus rotundus, Emblica officinalis, Emblica ribes, Holarrhena antidysentrica, Picrorrhiza kurroa, Berberis aristata, Piper longum, Piper longum (Root), Piper nigrum, Plumbago zeylanica, Saussurea lappa, Terminallia belerica, Terminallia chebula, Zingiber officinalis 25 mg each Boerhavia diffusa, Operculina terpathum 50 mg each Mandur Bhasma * 500 mg * Prepared using in-process control grinding at Particle size <2 µm and heated up to 770° C in Programmed Muffle Furnace (Gaja Puta) Each 1000 mg Sachet contains:

30. Characteristics of the Ingredients Rasa No. Guna No. Virya No. Vipaka No. Madhur 5 Ruksha 14 Usna 15 Madhur 6 Amla 2 Laghu 14 Sheet 3 Katu 12 Lavana Guru 1 Katu 14 Snigdha 3 Tikta 14 Tikshna 5 Kashay 5 Sheet 1 Madhur 1 Ruksha 1 Sheet 1 Madhur 1 Tikta 1 Laghu 1 Kashay 1 Mineral Origin Plant Origin

31. Effects Side-Effects Katu Tikta Kashaya Eliminate Kapha & Pitta Mouth Freshener Appetizer Digestive Acceptor Cleanser De-worming Antipyretic Detoxifier Aggravates Vata Murcha (Syncope) Daha (Burn) Shosh (Dehydration) Moh (Depression) Bhrama (Confusion) Glani (Guilt) Napusnsakta (Impotency) Atikrishta (Extreme Leanness) Madhur Amla Eliminate Vata Appetizer Nourishment Digestive Longevity Aggravates Kapha Aruchi (Anorexia) Prameha (Diabetes) Sthoulya (Obesity) Raktavikar (Blood Disorder) Daha (Burn) Pandu (Anemia) Bhrama (Confusion) Logistics of Therapeutic Effect - I Rasa

32. Ruksha Eliminates Kapha Aggravates Vata Snigdha Eliminates Vata Aggravates Kapha Laghu Eliminates Kapha Aggravates Vata Guru Eliminates Vata Aggravates Kapha Sheet Eliminates Pitta Aggravates Vata sleshma Usna Eliminates Vata sleshma Aggravates Pitta Tikshna Eliminates Kapha Aggravates Pitta Sthir Aggravates Kapha Usna Eliminates Kapha & Vata Aggravates Pitta Sheet Eliminates Pitta Aggravates Kapha & Vata Katu Eliminates Kapha Aggravates Vata & Pitta Madhur Eliminates Vata & Pitta Aggravates Kapha Guna: Veerya: Vipaka: Logistics of Therapeutic Effect - II

33. Randomized Controlled Clinical Trial A 12 week randomized, active controlled, single blind, pragmatic clinical study using Immbo (a Herbo -mineral Ayurvedic formulation) compared with Levocetrizine in the treatment of patients with Persistent Allergic Rhinitis (PER) Moulana Hospital, Perinthalmanna , Kerala Sample size: 180 patients Individual patient consent

34. Ethical clearance Study period: 06/07/2009 to 02/10/2010 Study material: 137/180 Study Groups: -Gr A – Immbo 3 gm /day* -Gr B – Levocetirizine 10 mg/day -Gr C – Immbo 3 gm *+ Levocetirizine 10mg/day Age : >10 to 70 years Sex (Male/Female) : 1.2:1 Duration of illness : >1 to 50 years * Initial 5 days – 4 gm /day Study Design & Methodology

35. Outcome P-value: Gr A Vs Gr B = 0.000, Gr A Vs Gr C = 0.000 P-value: Gr A Vs Gr B = 0.000, Gr A Vs Gr C = 0.003 Four Times More Effects & Four Times Less Side Effects in comparison to Levocetrizine (n=137/180)

36. Phase III Prospective, Randomized, Double blind, Active-controlled, Comparative, Parallel Group and Multicentric Clinical Study to Evaluate the efficacy, safety and tolerability of FDC of IMMBO- Herbo -mineral formula oral suspension/tablet versus FDC of Levocetrizine 2.5 mg + Montelukast 4 mg oral suspension/tablet in patients of Allergic Rhinitis Host institute: Department of Pediatrics, GSVM Medical College, Kanpur Ethical clearance received (dated 4 th June, 2022) CTRI registration No. REF/2022/06/055573 Randomized Controlled Clinical Trial - II

37. N = 239 IMMBO group – 114 (72 Male, 42 Female; Age group: 4 to 46 yrs ) Levocetrizine + Montelukast group – 110 (71 Male, 39 Female; Age group: 6 to 45 yrs ) Drop outs – 15 Study Design & Methodology

38. Effect on IgE levels (Average IgE value in IU/mL) Normal value: 1-190 IU/mL IMMBO shows significant immuno -modulatory properties p value = < 0.0001 IU/mL

39. Effect on Total Nasal Symptom Score Average TNSS scores mentioned p-value >0.0001 Statistical analysis done using paired t-test

40. Other Clinic based Studies Similar results seen in following studies Single dose (n=54) Single dose multi-centric (n=100) Multi dose (n=50)

41. Anti-Allergic Effect of IMMBO Delayed Type Hypersensitivity (increase in Paw Thickness)  Mean increase in paw thickness (in mm) IMMBO shows significant hypersensitivity control properties (immunity modulator) Group A SRBC Control Group B Levamisole Group C IMMBO (800 mg/kg; human equivalent to 129mg/kg)

42. Neutrophil Adhesion Assay IMMBO shows marked Neutrophil adhesion, thus showing good anti-inflammatory and immuno -modulatory properties. Group I Healthy Control Group II Cyclophosphamide (Immunosuppressant) Group III Cyclo + SRBC (Antigen stimulation) Group IV Cyclo + SRBC + IMMBO 200 mg/kg body wt. Group V Cyclo + SRBC + IMMBO 400 mg/kg body wt. Group VI Cyclo + SRBC + IMMBO 800 mg/kg body wt. Anti-inflammatory & Immuno surviellance Response of IMMBO *400 mg/kg is equivalent to 64 mg/kg human dose

43. IMMBO improves immuno globulin levels - antibody mediated immune modulator properties *200 mg/kg is equivalent to 30 mg/kg human dose IgM IgG IgA Immunity Enhancing Properties of IMMBO Group I Healthy Control Group II Cyclophosphamide (Immunosuppressant) Group III Cyclo + SRBC (Antigen stimulation) Group IV Cyclo + SRBC + IMMBO 200 mg/kg body wt. Group V Cyclo + SRBC + IMMBO 400 mg/kg body wt. Group VI Cyclo + SRBC + IMMBO 800 mg/kg body wt.

44. Effect of IMMBO on Cytokine Expression Biomarker Cyclophosphatase (Immunosuppressant) IMMBO TNF-a Lowers expression Corrects to normal levels, but effect better at low dose IL-10 Increases expression Corrects to normal level but at higher dose IL-6 Increases expression Corrects to almost normal levels at all tested doses NF-kb Increases expression Corrects to normal levels in a dose dependent manner IL-1b Lowers expression  Maintains higher levels of expression IFN-g Lowers expression Corrects to normal level at all tested doses IMMBO normalized the expression of cytokines, thus, regulating immune and inflammatory response.

45. Effect of IMMBO on Cell Regulation Representation of fold-change in biomarkers normalized to GAPDH control IMMBO normalizes cell regulatory markers suggesting its role in cell regulation that could be defined as Samyak Dhatu Pariposhan Kram

46. Table: Potential of IMMBO for inhibition of histamine release from mast (P815) cells; Lower IC50 value means higher efficacy IMMBO test sample has potential in inhibiting the histamine release from mast cells suggesting its role as anti-allergic. Source: Zandu Emami Ltd Anti-Histaminic Inhibition of Histamine release using P815 cell line IC50 ( μ g/mL)

47. Source: Zandu Emami Ltd Table: NK cell activity of IMMBO test sample IMMBO test sample has NK cell activity suggesting its role as an immuno-modulator. Natural Killer Cell Properties IMMBO

48. Results At A Glance First reported fastest acting herbo mineral Ayurvedic compound to treat Acute/ Persistent Allergic Rhinitis Most of the symptoms improve within two to fifteen minutes duration after swallowing with saliva Anti-allergic Anti-inflammatory Immuno -modulator Non sedative Non steroidal Evidently Effective

49. Recurrent Acute/ Chronic Pancreatitis Pancreatitis is an irreversible and progressive inflammatory disorder of pancreas having unknown etiology Globally uprising trend Herbo mineral formulation (HMF) comprising of Copper, Mercury and Sulphur processed with Luffa echinata , Clitoria ternatea and lemon juice over years following principles of Shata Guna Gandhak Jarana brings complete and sustainable relief significantly

50. After 1 st cycle After 32 nd cycle After 16 th cycle After 50 th cycle Analyzed using XRD, EDAX and SEM at IISc, Bangalore Standardization and Chemical Formula Source: Indian Institute of Science, Bengaluru, India

51. Safety Studies – OECD guidelines Data on file; Courtesy: Vipragen Biosciences Limited, Mysuru

52. Experimental Study Age: 8-10 weeks Body weight: 180-220g Study duration: Three weeks Source: Vipragen Biosciences, Mysuru, India Two consecutive studies Protective activity of HMF on L-Arginine induced chronic pancreatitis in male albino wistar rats

53. Study Groups and Dose Schedule Gr Treatment group Doses (I/II) Route No. of animals I Untreated control - - 6/6 II Disease control (L-Arginine) 2.0/ 2.0 g/kg IP injection 6/6 III HMF + L-Arginine 25/ 13 mg/kg Oral 6/6 IV HMF + L-Arginine 50/ 19 mg/kg Oral 6/6 V HMF + L-Arginine 100/ 25 mg/kg Oral 6/6 VI 6-α-methylprednisolone + L-Arginine 30/ 15 mg/kg Oral 6/6

54. HMF exhibits significant protective effect at 25 mg/kg/day in comparison to other groups GII: One animal in severe Pancreatitis category died on Day 11 GVI: Two animals in moderate Pancreatitis category died on Day 13 and 14 Histopathology Protection from Pancreatitis in experimental study

55. * * One animal died on Day 18 in G-VI, histopathology could not be done due to autolysis Histopathology report - II Experimental Study - II

56. Results at a Glance (n = 1700) Source: Padaav Specialty Ayurvedic Treatment Centre Didn't start treatment, 39 Lost to follow up, 11 Death, 30 Progression/ Relapse, 12 Incomplete Treatment, 396 Complete Treatment, 9 16 On Treatment, 2 96

57. Significant Impact after one year of AYT n= 916/1700 p-value>0.0001 Source: Padaav Specialty Ayurvedic Treatment Centre 93.2% reduction in emergency attacks 97.6% reduction in emergency hospitalizations Pre Post Pre Post 2781 189 1530 36

58. Status of patients post AYT Symptom free survival in years No. of patients n = 916/1700 # First patient completes 26 years long disease free survival after getting nine recurring attacks in the year prior to AYT *5 deaths post relapse and 1 due to cardiac arrest Source: Padaav Specialty Ayurvedic Treatment Centre

59. Publications Prakash VB, Prakash S, Negi N, Sati ST. Significant Reduction of Carbohydrate 19-9 Antigen Levels in a Patient of Acute on Chronic Pancreatitis through Ayurvedic Treatment Protocol. IJSR. 2023;12(7):235-239. Prakash VB, Prakash S, Sharma S, Tiwari S. Transformation of Copper into therapeutic mineral complex following principles of Rasa Shastra . Annals Ayurvedic Med. 2020;9(3). Prakash VB, Prakash S, Sharma S, Tiwari S . Management of multi-relapsed chronic pancreatitis through Rasaushadhis : A case study. J Ayurveda Case Rep. 2020;3:66-9. Prakash VB et al. CA19-9 Lowering Effect of Ayurvedic Mineral Complex in the Patients of Chronic Pancreatitis, EC Gastroenterology and Digestive System , 7.1 (2020):01-05. Prakash VB et al. Changing Demography of Pancreatitis Patients in India – A Hospital based Study, Acta Scientific Gastrointestinal Disorders 2.7 (2019):08-11. Prakash VB et al. Anti-Inflammatory Properties of a Processed Copper Complex in L-Arginine Induced Pancreatitis - Two Experimental Studies, EC Gastroenterology and Digestive System , 6.7 (2019):519-524. Prakash VB et al. Impact evaluation of Ayurvedic Treatment Protocol on three hundred nineteen cases of different variants of Pancreatitis, Pancreat Disord Ther (2018):8:2. Prakash VB et al. Relevance of Ayurvedic formulations in the management of Recurrent Acute/ Chronic Pancreatitis. TANG [HUMANITAS MEDICINE] (2017), Vol 7, e9.

60. BAMS Bridge between Ayurveda and Modern Science Enormous opportunities to earn job satisfaction, prestige, wealth, glamour, along with worldwide acceptance and recognition of Ayurveda as therapeutics rather than merely wellness

61. Need There is a dire need to develop science to convert proof of efficacy into scientific theory Interdisciplinary scientific development of Ayurveda Leap from mysticism to science

62. Thank You