Ayurvedic Treatment for Migraine Pharmaceutical perspective Clinic to Concept (Positivism) A Scientific Model by: Vaidya Balendu Prakash Ayurvedic Consultant VCPC Research Foundation(SIROs), Dehradun Ipca Laboratories Limited, Mumbai Dharamshila Cancer Hospital, Delhi vcpcrf@gmail.com, www.padaav.com
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 conjunction (Allopathy) with Medical systems Western in medicine
Unique feature A registered physician of Ayurveda and Unani can prepare medicines for the use in his own clinical practice without obtaining manufacturing license. Integrated system of education and research Blending of modern diagnostics with traditional knowledge Scope for documentation (GCP guidelines)
Positivism: A scientific approach (19th century Comte) Observation Drug discovery: 15 years, $ 1.8 billion Hypothesis Penicillin Nitrous oxide Theory Discovery & Development of Nitrous Oxide & Penicillin
Acute Promyelocytic leukemia-i Observation Preliminary study: Sorting out of patients of APML Pilot Study: 1. Bone marrow aspiration & peripheral blood smear measurement 2. Liver & Kidney function test for toxicology evaluation Hypothesis Can silver based compound be effective for treating the APML patients? - Yes Theory 1. Standardization of raw material 2. Development of in-process quality control technique 3. Standardization of finished product 4. Toxicological studies 5. Effective Dose studies 6. Human trials 7. Pharmacological explanations
Acute Promyelocytic leukemia-ii US and European patent 191708 dated 08/23/1999 through NRDC, Govt. of India Prakash et al: J-AIM, Vol. 1, No. 3, July 2010, P 215-218 Reverse pharmacology under industry/ institute partnership Availability at specific clinics and hospitals Partially sponsored by CCRAS, Dept of AYUSH, Govt. of India,
Migraine A common form of headache with debility causing characteristics Affects nearly 280 million world population. Female, male ratio 3:1 Disease of productive age group; causing substantial burden In USA 30 million cases Direct burden $11.07 billion/year* Out patient (5.21), pharmaceutical (4.61), In-patient (0.73), emergency (0.52) *Headache 2008; 48(4):553-563
Migraine and Allopathy Unknown etiology Various theories and treatment Prolong uses may cause substantial side effects including transformed, chronic or medication overuse headache Big challenge
Migraine and Ayurveda Shleshma-pitta Vs Migraine
Causes of Shleshma-pitta Irregular eating habits such as, wrong food combination, quantity and timings Long gap or intermittent eating pattern, crash dieting Stale, over salty, spicy, sour food Over use of tea coffee, aerated drinks and reprocessed food Arrest of basic urges like sleep, hunger, urine, stool etc. Irregular life style, anxiety, worry and lack of exercises Use of certain drugs and diseases affecting the hepato-billiary system
Ayurvedic Treatment Protocol (ATP) Regulated diet (3 meals + 3 snacks) 1600 calories each day Eight hour sleep Combination of four classical Ayurvedic formulations (Herbo- minerals)* consisting of: Narikela Lavan, Numax, Rasonadi vati and Godanti Mishran *Modified form with in-house standards for the material and manufacturing to assure sustainable bench marking and reproducibilty
Methodology IHS diagnostic Criteria for migraine without aura VAS and MIDAS scoring to access severity and impact at day 0, 30, 60 and 90 Individual consent Post card registry system 120 days regular and paid treatment Long term follow up
Observation and findings Retrospective: 1985 to 2002 Prospective I: June 2002 to Dec 2004 (Chandigarh) Prospective - II: May 2005 till date (Karnataka, Maharhastra, Uttrakhand, Uttar Pradesh, Andhra Pradesh and Haryana)* Prospective - III: June 2007 to June 2009 (Dehradun, Bangalore, Mysore)
Poster Presented and Discussed at 16th Migraine Trust International Symposium, 18-20 September 2006 The Conference Centre, Kensington Town Hall, London, UK Cephalalgia, 2006, Vol 26, no. 11, p 1367
Poster Presented at 13th Congress on Headache organized by International Headache Society, 28th June to 2nd July 2007, at Stockholm, Sweden Cephalalgia, 2007, vol 27, no. 6, p 745
Poster Presented at 52nd Meeting of the American Headache Society, 24th 27th June 2010, at Los Angeles, USA Headache 2010; vol. 50 (Suppl 1), p 53
Research Paper on Response of Ayurvedic therapy in the treatment of migraine without aura Vaidya Balendu Prakash, S Raghavendra Babu, K Suresh Kumar Published in the International Journal of Ayurveda Research, Publication of AYUSH, Department of Health & Family Welfare, Government of India
Acute and Sub acute safety studies on AYFs (OECD guidelines) Recommended Human Dose 7.3 gm/day Rat (Daily Dose) Mice (Daily Dose) 0.7 gm (Equivalent) 1.47 gm (Equivalent) 2.23 gm (Three times) 3.04 gm (Two times) 7.45 gm (Ten times) 6.48 gm (Four times) No LD50 at 5 gm (maximum) dose Prakash et al. IJTPR 2010, vol. 2, issue 2, june-august 2010
Sub Chronic Toxicity Studies in rats (OECD guidelines) GI Control Animals G II G III G IV GV Normal* Medi um High Satellite 20 20 20 20 20 Treatment (day) 180 180 180 180 180 Sacrifice (day) 181 181 181 181 211 Mortality - - - 2 2 ( = ) Well tolerated
Takeaway Messages The results indicate that ATP brings significant relief to migraine patients ATP is well tolerated and safe ATP shows new pathway towards the diagnosis and management of migraine
Current scenario Manufacturing by BBS Pvt Ltd, Dehradun Continuity of clinical service Chemical nomenclature at IISc Bangalore Pharmacological studies at Department of Pharmacology, AIIMS, Delhi Randomized two arm study at Department of Neurology at AIIMS, Delhi Integrated Migraine clinic at Mumbai with an authoritative neurologist on the subject
Acknowledgement Ipca Laboratories Limited, Mumbai specially to Mr. Prem Godha, Managing Director Prof (Dr) R M Varma, Dr Jayprakash Narayan Volunteer patients & Media Vd Raghvender Babu, Vd Suresh Kumar, Vd Naveen Sharma and all participating Ayurvedic physicians Collaborating faculty and staff of BCPMumbai, IISc- Bangalore and AIIMS- Delhi