World's first ayush phase-3 trial for rheumatoid arthritis in India

Study will begin in May, to take two years to complete

Come May, the world’s first multi-centre phase-3 clinical trial to examine the efficacy of ayurvedic treatment for rheumatoid arthritis will begin in India.

The 240-volunteer trial would be conducted across three cities in India – Coimbatore, Bengaluru and Mumbai--in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use – Good Clinical Practice (ICH-GCP) guidelines.

In a statement, the Ayush Ministry said on Wednesday that the trial will be closely monitored by Daniel Erick Furst, rheumatologist at University of California, Los Angeles.

“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) Ltd and the Central Council for Research in Ayurveda (CCRAS), a government of India agency under the Ministry of Ayush,” the statement said.

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.”

Edzard Ernst, 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), the Ayush Ministry claimed.

He has designed the study and will be mentoring it. “In connection with this trial Dr. Daniel Furst, has started training all the investigators from centers on the conduct of the study adhering to the gold standards of clinical research, thus enabling globalization of Ayurveda,” the statement added.

The study is expected to begin in May and is expected to be completed in the next two years.

M.N. Shubhashree, Research Officer, Central Ayurveda Research Institute for Metabolic Disorders, Bengaluru, “The sample size has increased almost 5 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 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 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.

The Ayush Ministry claimed that the multidimensional approach by combining traditional and modern medicine is growing day by day in western countries.