The Union Ministry of Ayush is conducting a multi-center Phase III clinical trial — the first in the world — to examine the efficacy of Ayurveda in Rheumatoid Arthritis treatment, it said on Wednesday.
The clinical trial will follow the stringent guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use – Good Clinical Practice and will be monitored by renowned University of California, Los Angeles, (UCLA) rheumatologist Dr Daniel Erick Furst.
The project is among the first multi-center Phase III double blind double dummy clinical trials on Ayurveda’s efficacy in managing Rheumatoid Arthritis. The trials will be conducted by AVP Research Foundation, affiliated to The Arya Vaidya Pharmacy (Coimbatore), and the Central Council for Research in Ayurveda, under the ministry.
AVP Research Foundation Director and the study’s co-investigator Dr Somit Kumar said Ayurveda research in Rheumatology was being taken global through AMRA, a double-blind double dummy randomised clinical trial.
Central Ayurveda Research Institute for Metabolic Disorders, Bengaluru, Research Officer Dr MN Shubhashree said the study was expected to begin in May and be completed in two years. The sample size has risen five times from 48 to 240 patients.
Dr Shubhashree said the clinical trials would be conducted at AVP Research Foundation in Coimbatore, Raja Ramdeo Anandilala Central Ayurveda Research Institute for Cancer in Mumbai, and Central Ayurveda Research Institute for Metabolic Disorders in Bengaluru.
Rheumatologist Dr Edzard Ernst, the Director of Clinical Research at Arthritis Association of South California and a critic of Complementary and Alternative Medicine (CAM), endorsed the study as a model for future investigations on CAM.
Having designed the study, Dr Ernst will mentor the researchers.
Earlier, the National Institutes of Health in the US funded a clinical trial at Seattle’s University of Washington to compare the efficacy and safety of classical Ayurvedic treatment for Rheumatoid Arthritis. The study’s findings were published in journals such as the Annals of Rheumatic Diseases and the Journal of Clinical Rheumatology.