The Ministry of AYUSH is conducting the world’s first multicentre phase-III clinical trial examining the efficacy of Ayurveda in the treatment of rheumatoid arthritis. The clinical trial will be conducted in accordance with stringent International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use – Good Clinical Practice (ICH- GCP) guidelines and is being closely monitored by Dr Daniel Erick Furst, a renowned rheumatologist at the University of California Los Angeles in the US.
This project is one of the first multi-centre phase-III double-blind double-dummy clinical trials on the efficacy of Ayurveda in the management of rheumatoid arthritis. This will be conducted by AVP Research Foundation, a research institution affiliated with The Arya Vaidya Pharmacy (Coimbatore) and the Central Council for Research in Ayurveda (CCRAS), a government of India agency under the the Ministry of Ayush.
Dr Edzard Ernst, world-renowned rheumatologist, currently the Director of Clinical Research at Arthritis Association of South California (AASC) and a vociferous critic of CAM, endorsed the study as a model for future investigations on Complementary and Alternative Medicine (CAM). He has designed the study and will be mentoring it. In connection with this trial, Dr Furst, has started training all the investigators from centres on the conduct of the study adhering to the gold standards of clinical research, thus enabling globalisation of Ayurveda.
Dr Somit Kumar, Director, AVP Research Foundation and Co-Investigator of this study, said, “AMRA, a double-blind double-dummy randomised clinical trial, is taking Ayurveda research in rheumatology to a global stage.”
Dr MN Shubhashree, Research Officer, Central Ayurveda Research Institute for Metabolic Disorders, Bengaluru, said, “The study is expected to begin in May 2022 and is expected to be completed in next two years. The sample size has increased almost five times, from 48 patients to 240. Clinical trials will be conducted at three locations: AVP Research Foundation in Coimbatore, Central Ayurveda Research Institute for Metabolic Disorders in Bengaluru and the Raja Ramdeo Anandilala Central Ayurveda Research Institute for Cancer in Mumbai.”
Earlier, the National Institutes of Health in the US funded a clinical trial at the University of Washington in Seattle to compare the efficacy and safety of classical Ayurvedic treatment to standard Allopathic treatment for rheumatoid arthritis. The findings of this study have been published in prestigious journals such as the Annals of Rheumatic Diseases and the Journal of Clinical Rheumatology.