Ashwagandha extract well tolerated over 24 weeks, study finds; no liver or kidney injury
A multicentre clinical study involving 1,200 adults found that daily use of a standardised Ashwagandha root extract for 24 weeks was well tolerated, with no evidence of treatment-related liver or kidney injury and no significant difference in vaccine-induced immune response.
New Delhi: A large multicentre clinical study published in Frontiers in Medicine found daily administration of a standardised Ashwagandha root extract for 24 weeks was well tolerated with no evidence of treatment‑related hepatic or renal injury, the government said on Monday.
The statement from the Ministry of Ayush said the study published on August 20 is based on a multicentre, randomised, double‑blind, placebo‑controlled trial of a safe prolonged prophylactic use and tolerability of Ashwagandha following COVISHIELD vaccination over 24 weeks.
The study found a favourable safety and tolerability profile for the standardised Ashwagandha root extract over the 24-week intervention period, the statement said.
“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,” it noted.
The ministry said that zero serious adverse events were considered attributable to the study intervention, and zero participants withdrew from the trial because of an adverse event.
A multidisciplinary team of 45 researchers from 9 institutions conducted the research on 1,200 apparently healthy adults aged 18–70 years who had received a first, second or booster dose of COVISHIELD vaccine. Nearly 86 per cent of enrolled 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 study was conducted across seven study sites in India and included clinical, laboratory and immunological assessments.
Participants received the intervention for 24 weeks and were followed through week 28, the statement noted.
The study was conducted by experts from ayurveda, clinical medicine, rheumatology, complementary and integrative health and related disciplines.
Vaidya Rajesh Kotecha, Secretary, Ministry of Ayush, emphasised that the findings contribute to the robust scientific evidence supporting 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 added.
Dr. Arvind Chopra, Ayush Distinguished Scientist Chair and Director & Chief Rheumatologist at the Centre for Rheumatic Diseases, Pune, India, and lead author of the study said that findings prove Ashwagandha did not interfere with vaccine-induced immunity, with high levels of neutralising activity maintained across both the Ashwagandha and placebo groups.
The study 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 the Ashwagandha and placebo groups, with no statistically significant difference between the groups.
