Study protocol on Covishield plus Ashwagandha published in top research journal

Rajesh Kotecha, secretary, Ministry of AYUSH, told The Indian Express that this study adopts a novel approach and the scientific community is eager to explore the impact on the current vaccination programme by improving immunogenicity and protection with simple and safe intervention. This hypothesis of better efficacy with a combination of vaccine (Covishield) and Ashwagandha is being tested in a drug trial launched by Ministry of AYUSH and its research wing (CCRAS) in several clinical centres across Pune, Mumbai, Nagpur, Delhi and Jaipur, among other cities.

After vaccination with Covishield, healthy volunteers will be checked by expert physicians and randomised to receive either vaccine or vaccine plus Ashwagandha in this 1500 sample size prospective, double-blind, parallel-group, placebo-controlled and two-arm study.

“The main outcome measure is early and persistent long-term immunogenicity as measured by SARS-CoV-2 spike (S1) and RBD-specific IgG antibody titres. Several other measures include safety, breakthrough infections, quality of life and cellular immune memory cell responses. Efficacy and safety will be assessed at several time points during this 24-week study, which can be extended up to 48 weeks in case of early success with the Ashwagandha-Covishield combination,” said Dr Arvind Chopra, director of the Centre for Rheumatic Diseases, Pune, who has authored several research protocols for completed Ayurveda drug trials in Covid-19 and is the first author of the study.

Publication of study protocols ensures greater transparency in the research process, study researchers said.

Prof Bhushan Patwardhan, national AYUSH research professor and chair of AYUSH Covid task force, is the senior author and along with a team at Pune University, he has carried out research on Ashwagandha.

“Ashwagandha is a time-honoured traditional Ayurvedic herbal drug for boosting immunity and restoring deranged immune response, which characterises several autoimmune and infectious diseases including Covid-19. Host immunity is pivotal for prevention and recovery…,” said Dr Patwardhan.