Ministry announcement: 28 September 2026
Original study publication: 20 August 2026
Study country: India
Global relevance: Ashwagandha safety, supplement quality and prolonged use
Primary sources: Ministry of Ayush through the Press Information Bureau and Frontiers in Medicine
A large Ashwagandha safety trial involving 1,200 adults in India found that a standardized aqueous Ashwagandha root extract was generally well tolerated when taken daily for 24 weeks. Group-level liver and kidney laboratory measurements remained within the reported reference ranges, no serious adverse event was attributed to the study intervention, and no participant withdrew because of an adverse event [1,2].
The findings provide important reassurance about the studied preparation and dose. They do not prove that every Ashwagandha product is free from liver risk or suitable for every patient. Mild liver enzyme abnormalities occurred more often in the Ashwagandha group than in the placebo group, and the participants were predominantly healthy younger adults rather than elderly or medically complex patients [2].
What the Ashwagandha Safety Trial Tested
The randomized, double-blind, placebo-controlled trial was conducted at seven centres across India. All participants had received a first, second or booster dose of COVISHIELD and were randomly assigned to Ashwagandha or a matching placebo [2].
The intervention contained 500 mg of standardized aqueous Ashwagandha root extract each day, described as equivalent to approximately 4 grams of raw Ashwagandha root powder. Participants received the intervention for 24 weeks and underwent final follow-up at week 28 [1,2].
Of the 1,200 randomized participants, 598 received Ashwagandha and 602 received placebo. A total of 1,032 participants, representing 86% of the original cohort, completed the trial [2].
| Trial measure | Study information |
|---|---|
| Study design | Randomized, double-blind, placebo-controlled, multicentre trial |
| Participants | 1,200 apparently healthy vaccinated adults |
| Ashwagandha group | 598 participants |
| Placebo group | 602 participants |
| Studied dose | 500 mg standardized aqueous root extract daily |
| Root powder equivalent | Approximately 4 grams daily |
| Treatment period | 24 weeks |
| Final follow-up | Week 28 |
| Completed trial | 1,032 participants, or 86% |
| Main safety finding | No treatment-related liver or kidney injury diagnosed |
| Immune finding | No statistically significant additional humoral immune benefit |
The published abstract and the PIB release describe an eligible age range of 18 to 70 years. However, the detailed selection-criteria section of the paper states 18 to 65 years. The actual cohort was predominantly young, with a mean age of approximately 29 years. This internal age-range discrepancy does not alter the primary findings, but it should be recognized when interpreting the population studied [1,2].
What the Trial Found About Liver Safety
The researchers monitored liver enzymes, bilirubin and other biochemical markers at scheduled intervals. Group-level liver laboratory measurements remained within the reference ranges, and the investigators reported no treatment-related hepatic injury [1,2].
Individual mild liver-test abnormalities were nevertheless recorded. Approximately 2% of participants receiving Ashwagandha developed mild hepatic transaminase abnormalities, compared with approximately 0.7% of participants receiving placebo. These abnormalities were described as elevations of about 1.5 times the upper limit of normal [2].
This distinction matters. The statement that no treatment-related liver injury occurred means that the researchers did not diagnose clinically significant hepatic injury attributable to the trial product. It does not mean that every liver test remained unchanged in every participant.
The number of participants with an abnormal liver-function adverse event was six in the Ashwagandha group and three in the placebo group. The paper did not establish that this numerical difference represented clinically important Ashwagandha-induced liver disease [2].
What the Trial Found About Kidney Safety
Creatinine, blood urea and other renal measurements remained within the reported physiological reference ranges during scheduled assessments. The investigators found no evidence of treatment-related kidney injury [1,2].
These findings are reassuring for healthy adults taking the specific standardized product under controlled trial conditions. They should not automatically be extended to patients with chronic kidney disease, dehydration, multiple interacting medicines or other conditions that were not adequately represented in the trial.
Adverse Events Were Generally Mild and Comparable With Placebo
The Ashwagandha group experienced 337 recorded adverse events, compared with 309 in the placebo group. Most events were mild or moderate, self-limiting and resolved within one or two days [2].
Digestive complaints such as hyperacidity, diarrhoea, constipation, dyspepsia and nonspecific abdominal discomfort generally occurred in fewer than 3% of participants. Other reported events included headache, giddiness, sleep changes, fever and upper respiratory infections [2].
Nine participants experienced events considered possibly or probably related to the intervention. Seven were in the Ashwagandha group and two were in the placebo group. Events in the Ashwagandha group included acid-peptic symptoms, excessive sleepiness, giddiness, oral mucosal ulcers and unexplained changes in body weight. These were classified as mild to moderate [2].
Eight serious adverse events occurred during the trial, six in the Ashwagandha group and two in the placebo group. They included conditions such as appendicitis, colitis, acute abdominal or chest pain, gastroenteritis and road-traffic injuries. After medical review, none was considered related to Ashwagandha or placebo, and all affected participants recovered [2].
No deaths occurred, no participant withdrew because of an adverse event, and no serious adverse event was attributed to the study intervention [1,2].
The Trial Did Not Prove an Additional Immune Boost
The study was conducted partly to determine whether Ashwagandha added a measurable immune benefit after COVISHIELD vaccination. It did not demonstrate a statistically significant additional humoral immune effect [1,2].
Virus-neutralising activity remained above 85% in both groups, with no significant difference between Ashwagandha and placebo. The cumulative incidence of breakthrough SARS-CoV-2 infection was approximately 3.9% and did not differ significantly between the groups [1,2].
Around 70% of participants were already positive for nucleocapsid antibodies at baseline, suggesting previous SARS-CoV-2 infection. More than 88% entered the trial after a second vaccine dose or booster, when antibody responses were already mature or close to their maximum. This created a ceiling effect that made an additional immune response difficult to detect [2].
A numerically higher antibody response appeared in some participants who started Ashwagandha after their first vaccine dose, but this difference was not statistically significant, and that subgroup was too small for reliable independent conclusions [2].
The evidence therefore supports the statement that Ashwagandha did not interfere with vaccine-induced immunity. It does not support marketing claims that the studied dose produced a proven additional antibody boost.
Why These Findings Do Not Apply to Every Ashwagandha Product
The trial tested one carefully defined preparation: a standardized aqueous extract made from Ashwagandha root. Its findings cannot automatically be transferred to leaf extracts, concentrated root-and-leaf combinations, gummies, powders of uncertain identity, multi-ingredient supplements or products containing undisclosed substances.
Ashwagandha products can differ in the plant part used, extraction method, withanolide profile, dose, purity, contaminants, accompanying ingredients and manufacturing quality. Two products carrying the same herb name may therefore produce different exposure levels and safety profiles [3].
The preparation was administered within a monitored clinical trial. Participants underwent baseline screening, repeated clinical assessments and scheduled blood testing. Unsupervised consumers may have pre-existing liver disease, use interacting medicines or continue the herb despite developing warning symptoms.
The trial also covered 24 weeks of daily treatment. It does not establish the safety of continuous use for several years or indefinite self-medication.
Why Rare Ashwagandha Related Liver Injury Still Requires Attention
Published case reports and case series have associated some Ashwagandha-containing supplements with cholestatic or mixed-pattern liver injury. Reported symptoms have included jaundice, severe itching, nausea, fatigue, abdominal discomfort and marked bilirubin elevation [3–5].
One international case series described five patients who developed liver injury after using Ashwagandha-containing supplements. Symptoms generally appeared between two and twelve weeks after treatment began. No patient developed liver failure, and liver tests eventually normalized after discontinuation in the followed cases [4].
A subsequent Indian case series also described probable or possible Ashwagandha-associated liver injury, including severe outcomes among some patients with pre-existing chronic liver disease [5].
Case series demonstrate that an adverse reaction may occur, but they cannot determine how commonly it occurs among all Ashwagandha users. Conversely, a randomized trial with 598 Ashwagandha-exposed participants cannot rule out an uncommon reaction that might occur only once among several thousand susceptible users.
The new trial and the liver-injury reports are therefore not mutually contradictory. The trial indicates that the standardized product was generally well tolerated in the studied healthy population. The case reports indicate that individual susceptibility, underlying liver disease, product composition or other factors may still produce clinically significant injury in uncommon circumstances.
Who Was Not Adequately Represented in the Trial
The researchers explicitly stated that their findings should not be extrapolated to elderly, immunosuppressed or substantially comorbid populations. Although the formal eligibility range extended into later adulthood, the average participant was approximately 29 years old [2].
People with conditions that could impair immune function were excluded. Recent users of Ashwagandha and other traditional products intended for COVID prevention or immune support were also excluded.
The trial therefore provides limited information about people with cirrhosis, active hepatitis, significant fatty liver disease, advanced kidney disease, autoimmune disease, cancer treatment, organ transplantation or extensive medicine use.
It also did not directly evaluate Ashwagandha for anxiety, depression, insomnia, thyroid disease, infertility, sexual function, muscle performance or other frequently advertised indications [2].
What Patients Should Understand Before Using Ashwagandha
For an otherwise healthy adult, the study offers reassuring evidence for 24 weeks of the specific standardized root extract at the studied dose. It does not establish one universal dose for all Ashwagandha preparations or all health conditions.
People with existing liver or thyroid disease, significant medical comorbidities, immunosuppression or multiple prescription medicines should obtain individualized clinical advice before prolonged use. The same caution applies during pregnancy and breastfeeding [3].
A patient should stop the supplement and obtain medical assessment if jaundice, dark urine, pale stools, severe itching, persistent nausea, unusual fatigue or significant abdominal discomfort develops. The clinician should be told the exact product name, dose, duration and every other medicine or supplement being used.
Where prolonged treatment is clinically necessary, baseline and follow-up liver testing may be considered according to the patient’s medical history, risk factors, symptoms and concurrent medicines.
Ayurvedic Interpretation of the Findings
Ashwagandha is traditionally used within Ayurveda as a Rasayana, meaning a rejuvenative approach intended to support resilience, recovery, strength and healthy tissue function. Classical Ayurvedic prescribing does not assume that every person should receive the same herb in the same preparation or dose.
An Ayurvedic physician considers the patient’s constitution, digestive capacity, age, strength, disease state, season, accompanying herbs and the substance used to administer the medicine. Root powder, aqueous extract, medicated ghee, milk preparation and compound formulations are not clinically identical.
The trial strengthens the modern evidence base for one standardized Ashwagandha root preparation. It also supports a broader Ayurvedic principle: reliable results require the correct substance, appropriate dose, suitable patient and proper clinical supervision.
Study Funding and Transparency
The trial was funded by the Central Council for Research in Ayurvedic Sciences under the Ministry of Ayush. Several authors were affiliated with the study sponsor or participating government research institutions [2].
The authors stated that the sponsor had no role in the analysis, interpretation or reporting of the results. Funding and institutional affiliations do not invalidate the findings, but they should remain visible when the study is reported and independently evaluated.
What the Ashwagandha Safety Trial Ultimately Shows
The trial provides strong evidence that 500 mg per day of the studied standardized aqueous Ashwagandha root extract was generally well tolerated for 24 weeks in predominantly young, apparently healthy COVISHIELD-vaccinated adults.
No treatment-related serious adverse event, clinically diagnosed liver injury or kidney injury was identified. Mild transaminase abnormalities occurred in 2% of Ashwagandha recipients compared with 0.7% of placebo recipients, and no additional statistically significant humoral immune benefit was demonstrated.
The evidence supports responsible confidence in a quality-controlled Ashwagandha preparation. It does not justify treating every commercial product, every dose or every patient as equally risk-free.
Frequently Asked Questions
Is Ashwagandha safe to take for 24 weeks?
A large randomized trial found that a standardized aqueous Ashwagandha root extract was generally well tolerated at 500 mg daily for 24 weeks in predominantly healthy younger adults. The finding applies to the studied product and population and does not guarantee that every commercial supplement or every patient will have the same experience.
Did the trial prove that Ashwagandha cannot affect the liver?
No. The trial found no clinically diagnosed treatment-related liver injury, but mild liver enzyme abnormalities occurred in 2% of Ashwagandha recipients and 0.7% of placebo recipients. Rare liver injury has also been described in published case reports, particularly among susceptible individuals or users of different products.
What Ashwagandha dose was used in the study?
Participants received 500 mg of a standardized aqueous Ashwagandha root extract once daily. The researchers described this amount as equivalent to approximately 4 grams of raw root powder. This does not mean that 500 mg of every extract or four grams of every powder will be chemically or clinically equivalent.
Did Ashwagandha improve immunity after COVISHIELD vaccination?
The study did not demonstrate a statistically significant additional humoral immune benefit. Antibody and virus-neutralising responses were already high in both groups. Ashwagandha did not appear to interfere with vaccine-induced immunity, but the trial does not support a definite claim that it enhanced vaccine antibody responses.
Can older adults or people with chronic disease rely on these findings?
Not fully. The actual study population was predominantly young and apparently healthy. The researchers specifically cautioned against extrapolating the results to elderly, immunosuppressed or substantially comorbid patients. Such patients require individualized assessment before starting prolonged Ashwagandha treatment.
References
[1] Press Information Bureau. (2026, September 28). 24-week clinical trial finds no evidence of liver or kidney injury with standardised Ashwagandha root extract. Ministry of Ayush, Government of India.
https://www.pib.gov.in/PressReleasePage.aspx?PRID=2315947
Used for: Official announcement date, dose, participant numbers, completion rate, safety conclusions and vaccine-neutralisation findings.
[2] Chopra, A., Chaudhuri, S., Gundeti, M. S., Sarmukaddam, S., Tillu, G., Chavan-Gautam, P., et al. (2026). Safe prolonged prophylactic use and tolerability of Ashwagandha following COVISHIELD vaccination over 24 weeks: A multicentre randomized double-blind placebo-controlled trial. Frontiers in Medicine, 13, Article 1852954.
https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2026.1852954/full
Used for: Trial design, randomization, participant demographics, adverse events, liver-test findings, immunological results, limitations, funding and conflict disclosures.
[3] National Institutes of Health, Office of Dietary Supplements. (2025, May 2). Ashwagandha: Is it helpful for stress, anxiety, or sleep? Health professional fact sheet.
https://ods.od.nih.gov/factsheets/Ashwagandha-HealthProfessional/
Used for: Product variability, potential adverse effects, medicine interactions, thyroid considerations, pregnancy precautions and reported liver injury.
[4] Björnsson, H. K., Björnsson, E. S., Avula, B., Khan, I. A., Jonasson, J. G., Ghabril, M., Hayashi, P. H., & Navarro, V. (2020). Ashwagandha-induced liver injury: A case series from Iceland and the US Drug-Induced Liver Injury Network. Liver International, 40(4), 825–829.
https://pmc.ncbi.nlm.nih.gov/articles/PMC8041491/
Used for: Clinical pattern, latency, symptoms and outcomes reported in five suspected Ashwagandha-related liver-injury cases.
[5] Philips, C. A., Valsan, A., Theruvath, A. H., Ravindran, R., Oommen, T. T., Rajesh, S., Bishnu, S., Augustine, P., & Liver Research Club India. (2023). Ashwagandha-induced liver injury: A case series from India and literature review. Hepatology Communications, 7(10), e0270.
https://pmc.ncbi.nlm.nih.gov/articles/PMC10531359/
Used for: Indian clinical observations of suspected Ashwagandha-associated liver injury and the increased concern among patients with pre-existing chronic liver disease.
