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The clinical trial will be conducted following the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use – Good Clinical Practice guidelines, it stated.
It will be closely monitored by Dr Daniel Erick Furst, a renowned rheumatologist at the University of California, the statement mentioned.
This project is one of the first multi-centre phase-3 double-blind double-dummy clinical trials on the efficacy of Ayurveda in the management of rheumatoid arthritis, it claimed.
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Dr Somit Kumar, Director of 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 M N Shubhashree, Research Officer, Central Ayurveda Research Institute for Metabolic Disorders, Bengaluru, said the study is expected to begin in May and be completed in the next two years.
The sample size has increased almost 5 times, from 48 patients to 240, Dr Shubhashree said. ”Clinical trials will be conducted at 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 USA 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 statement said