AYUSH Ministry to Launch World's First Multicentre Phase 3 Ayurveda Clinical Trial for Rheumatoid Arthritis

According to an official release issued recently, the Ministry of Ayush is conducting the world's first multicenter phase III clinical trial examining the efficacy of Ayurveda in the treatment of Rheumatoid Arthritis. The clinical trial will be carried out in accordance with strict International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use – Good Clinical Practice (ICH- GCP) guidelines and will be closely monitored by Dr Daniel Erick Furst, a renowned rheumatologist at the University of California Los Angeles in the United States of America, according to a release from the AYUSH Ministry.

This is one of the first multi-center phase III double-blind double-dummy clinical trials to investigate the efficacy of Ayurveda in the treatment of Rheumatoid Arthritis.

AVP Research Foundation, a research institution affiliated with The Arya Vaidya Pharmacy (Coimbatore) Ltd, and the Central Council for Research in Ayurveda (CCRAS), a government of India agency under the Ministry of Ayush, will conduct the study.

According to the ministry, Dr. Edzard Ernst, a world-renowned rheumatologist who is currently the Director of Clinical Research at the Arthritis Association of South California (AASC) and a vocal critic of Complementary and Alternative Medicine (CAM), endorsed the study as a model for future CAM research.

In connection with this trial, Dr. Daniel Furst has begun training all investigators from centres on how to conduct the study in accordance with the gold standards of clinical research, allowing for the globalization of Ayurveda, according to the ministry.

"AMRA, a double-blind double-dummy randomized clinical trial, is taking Ayurveda research in Rheumatology to a global stage," said Dr. Somit Kumar, Director, AVP Research Foundation and Co-Investigator of this study.

"The study is expected to begin in May 2022 and is expected to be completed in the next two years," said Dr M N Shubhashree, Research Officer at the Central Ayurveda Research Institute for Metabolic Disorders in Bengaluru. The sample size has nearly doubled, from 48 to 240 patients.

Clinical trials will take place at three different locations: the AVP Research Foundation in Coimbatore, the Central Ayurveda Research Institute for Metabolic Disorders in Bengaluru, and the Raja Ramdeo Anandilala Central Ayurveda Research Institute for Cancer in Mumbai.

Previously, the National Institutes of Health in the United States of America funded a clinical trial at the University of Washington in Seattle to compare the efficacy and safety of classical Ayurvedic treatment for rheumatoid arthritis to standard Allopathic treatment. The results of this research was published in prestigious journals like the Annals of Rheumatic Diseases and the Journal of Clinical Rheumatology.