Daijiworld Media Network - New Delhi
New Delhi, Sep 29: A large multicentre clinical study has found that daily administration of a standardised Ashwagandha root extract for 24 weeks was well tolerated, with no evidence of treatment-related liver or kidney injury, the Ministry of Ayush said on Monday.
The study, published in *Frontiers in Medicine* on August 20, was based on a multicentre, randomised, double-blind, placebo-controlled clinical trial examining the prolonged prophylactic use and tolerability of Ashwagandha following COVISHIELD vaccination.
According to the Ministry of Ayush, the study found a favourable safety and tolerability profile for the standardised Ashwagandha root extract during the 24-week intervention period.
"Liver and kidney function parameters remained within the reported reference ranges, with assessments including liver enzymes, bilirubin, creatinine and blood urea showing no evidence of treatment-related hepatic or renal injury," the ministry said.
It added that no serious adverse event was considered attributable to the study intervention and no participant withdrew from the trial because of an adverse event.
The study involved a multidisciplinary team of 45 researchers from nine institutions and included 1,200 apparently healthy adults aged between 18 and 70 years who had received a first, second or booster dose of the COVISHIELD vaccine.
Nearly 86 per cent of the participants completed the study.
Participants were randomly assigned to receive either 500 mg of a standardised aqueous Ashwagandha root extract daily, equivalent to 4 grams of raw root powder, or a matching placebo.
The clinical trial was conducted across seven study sites in India and involved clinical, laboratory and immunological assessments. Participants received the intervention for 24 weeks and were followed until week 28.
Researchers from Ayurveda, clinical medicine, rheumatology, complementary and integrative health and related disciplines participated in the study.
Vaidya Rajesh Kotecha, Secretary, Ministry of Ayush, said the findings added to the scientific evidence on the safety and appropriate use of standardised Ayurveda interventions.
"High-quality clinical research strengthens the scientific evidence-base of Ayurveda and contributes to a deeper understanding of its potential within contemporary healthcare. The growing body of evidence from rigorous clinical studies is also supporting the responsible global utilisation of Ayurveda and its interventions across health and wellness settings," he said.
Dr Arvind Chopra, Ayush Distinguished Scientist Chair and Director and Chief Rheumatologist at the Centre for Rheumatic Diseases in Pune and lead author of the study, said the findings indicated that Ashwagandha did not interfere with vaccine-induced immunity.
The study found that high levels of neutralising activity were maintained in both the Ashwagandha and placebo groups.
The researchers also assessed the effect of 24-week administration of the standardised aqueous Ashwagandha root extract on the immune response following COVISHIELD vaccination.
Virus-neutralising activity exceeded 85 per cent in both groups, with no statistically significant difference between participants receiving Ashwagandha and those given the placebo.