NEW DELHI: The growing use of traditional remedies has brought renewed attention to a central question for Indian systems of medicine: how can their long-standing use be assessed against the standards of modern clinical research?
A 24-week multicentre trial of Ashwagandha, published in Frontiers in Medicine, adds to this effort, reporting no evidence of liver or kidney injury from the specific standardised preparation tested.
The study, involving 1,200 adults, examined the safety and tolerability of daily Ashwagandha use in apparently healthy people who had received a first, second or booster dose of COVISHIELD, a vaccine used against Covid virus during pandemic times a few years ago.
Researchers said the findings offer clinical evidence on one preparation, while underlining the need for further studies before broader conclusions can be drawn.
In the randomised, double-blind, placebo-controlled trial, participants aged 18 to 70 were assigned either 500 mg of standardised aqueous Ashwagandha root extract daily, equivalent to 4 gm of raw root powder, or a matching placebo. They were monitored during the 24-week treatment period and for another four weeks afterwards. Of those enrolled, 1,032 participants, or 86%, completed the study.
The researchers assessed liver and kidney function through laboratory tests, including liver enzymes, bilirubin, creatinine and blood urea. The parameters remained within the reported reference ranges, with no treatment-related liver or kidney injury identified. No serious adverse event was considered related to the intervention, and no participant withdrew because of an adverse event.
The trial also examined whether Ashwagandha affected the immune response following vaccination. Virus-neutralising activity remained above 85% in both groups, with no statistically significant difference between those receiving the extract and those given the placebo.
Dr Arvind Chopra, Ayush Distinguished Scientist Chair and director and chief rheumatologist at the Centre for Rheumatic Diseases, Pune, and the study’s lead author, said, “This large, multicentre, randomised clinical trial provides important evidence on the safety and tolerability of standardised Ashwagandha over 24 weeks. Throughout the study, liver and kidney function parameters remained within physiological reference ranges, with no treatment-related liver or kidney injury observed.
The study also demonstrated that Ashwagandha did not interfere with vaccine-induced immunity, with high levels of neutralising activity maintained across both the Ashwagandha and placebo groups. These findings reinforce the importance of evaluating standardised Ayurvedic preparations through rigorous, well-controlled clinical research.”
The research was conducted across seven centres in India by 45 researchers from nine institutions, including the Central Council for Research in Ayurvedic Sciences (CCRAS), the All India Institute of Ayurveda, the National Institute of Ayurveda in Jaipur, the Ayush Centre of Excellence, the Translational Health Science and Technology Institute and Savitribai Phule Pune University.
For Indian systems of medicine, such studies are part of a wider effort to build evidence through controlled trials, standardised preparations and measurable clinical outcomes. Traditional use can provide a basis for research, but findings from one formulation cannot automatically establish the safety or effectiveness of every product sold under the same name.
Vaidya Rajesh Kotecha, Secretary, Union Ayush Ministry, said, “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.”
Prof Bhushan Patwardhan, National Professor of Ayush and co-author, said, “This study is an important example of how Ayurveda can be evaluated through robust, contemporary clinical research without losing sight of its traditional foundations. The favourable safety and tolerability findings over 24 weeks add to the clinical evidence on standardised Ashwagandha preparations and underline the importance of evidence-based approaches for their responsible integration into healthcare.”
Prof (Vaidya) Rabinarayan Acharya, Director General, CCRAS, said, “Such well-designed clinical studies are important for strengthening the scientific evidence base of Ayurveda…”
The researchers cautioned that the findings apply to the specific standardised aqueous root extract and dose used in the trial, and not necessarily to other Ashwagandha products, formulations or doses. The participants were apparently healthy adults who had received COVISHIELD vaccination; the results therefore do not establish safety in people with existing liver or kidney disease or other medical conditions.
The study also does not establish Ashwagandha’s effectiveness for treating or preventing a particular illness. Further research involving different patient groups, longer follow-up and other preparations will be needed to clarify its wider role, said the researchers.
