For the trial, the enrollment of volunteers has begun in Pune and Mumbai and will soon commence in other centres such as Delhi, Nagpur, Jaipur, Belgaum and Hassan, Dr Arvind Chopra, chief clinical coordinator for the trial, told The Indian Express.
The Ministry of Ayush’s Central Council of Research in Ayurvedic Science (CCRAS) have commenced a trial to evaluate if Ashwagandha, a popular herb of the Ayurvedic system of medicine, can help improve the protection offered by anti-Covid vaccines.
For the trial, the enrollment of volunteers has begun in Pune and Mumbai and will soon commence in other centres such as Delhi, Nagpur, Jaipur, Belgaum and Hassan, Dr Arvind Chopra, chief clinical coordinator for the trial, told The Indian Express.
As many as 1200 participants are being enrolled in the standard controlled drug trial, Dr Chopra said.
“Variants of SARS-CoV2 virus and mutants are inevitable, and some may reduce the vaccine efficacy. Operationally, it is difficult to alter the Covid-19 vaccine in a short time to meet the new virus antigenic challenges. With this trial we hope to understand whether there can be a likely increase in the protection offered by anti-Covid-19 vaccine by addition of Ashwagandha Ayurvedic formulation,” he said.
Trial participants will be examined by both Ayurveda and modern medicine physicians, he added.
Rajesh Kotecha (Secretary, Ayush), Prof Bhushan Patwardhan (National Research Professor, Ayush) and Dr N Srikanth (Director General, CCRAS) are the prime movers of the study, the protocol for which was vetted by several experts and cleared by ethics committees.
Under the trial, participants will be randomised soon after vaccination and administered either Ashwagandha or a placebo. They will then be closely monitored for 28 weeks during which protective antibodies and immune cell responses will be measured at several points. In addition, breakthrough infections will be evaluated. “Participants will be monitored daily for Covid symptoms and/or drug side effects using a special mobile app developed by Centre for Rheumatic Diseases (CRD), Pune,” Dr Chopra, who is also the director of the centre, said.
Scientifically known as Withania somnifera, Ashwagandha has traditionally been used to modulate and enhance immunity and help in several infections and autoimmune disorders.
Recently, Chopra and his colleagues concluded a randomised controlled drug trial sponsored by Ministry of Ayush-Council of Scientific and Industrial Research to demonstrate the prophylaxis offered by Ashwagandha in high-risk personnel such as doctors and nurses.
Ashwagandha was shown to be similar to hydroxychloroquine (HCQS), which was extensively used and recommended by the Indian Council of Medical Research (ICMR) prior to vaccination. It is likely that several participants in these trials were exposed to Delta variant. An interim report of the trial in favour of Ashwagandha was published in a global peer-reviewed journal “Complementary Therapies in Medicine” in August 2021 .
“These trials have been consistent with the emerging policy on Ayurveda’s integration with modern medicine and instilling faith in the ongoing efforts by physicians from both in curbing the Covid-19 menace,” Dr Chopra said.
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