Ashwagandha (Withania somnifera): Evidence, Indian Rules and Liver Safety

Ashwagandha is the dried root of Withania somnifera, a shrub long used in Ayurveda and now sold across India as churna (powder), capsules of root extract and an added ingredient in protein powders and malted drinks. It is a herb, not a nutrient, so the body has no requirement for it. FSSAI's schedule of permitted botanicals lists the root at 3 to 6 g a day as powder, or 0.5 to 1 g a day as extract, for adults. Pooled trials point to small gains in sleep and stress scores, and case series from India and abroad link it to rare liver injury. This entry belongs to the supplements section of the handbook.

What is ashwagandha and what is it sold for?

It is a plant root, also sold as asgandh, that contains a family of compounds called withanolides. The United States government's centre for complementary health research (NCCIH) notes that these compounds have been associated with anti-inflammatory and antioxidant effects, and that supplements are promoted mainly for stress and anxiety, sleep, male fertility and athletic performance. Commercial extracts are usually standardised to a stated withanolide content: the extract used in several Indian trials was described by its investigators as standardised to 5 per cent withanolides.

Two products with the same name on the label can therefore be very different things. Root churna stirred into a glass of warm milk is whole plant material measured in grams; a capsule of extract is a concentrate measured in milligrams. The trials described below tested extracts for about eight to ten weeks, so their findings do not carry over to home-made powder taken for years.

The Indian position: no ICMR-NIN requirement, a schedule entry and a root-only rule

ICMR-NIN sets no requirement for ashwagandha, because it is not a nutrient. The Dietary Guidelines for Indians (2024) do not mention it at all; their only remark on supplements for fitness is the advice to avoid protein supplements for building muscle. The rules that apply come from two other bodies. FSSAI regulates ashwagandha when it is sold as a food, health supplement or nutraceutical. The Ministry of Ayush regulates it when it is sold as an Ayush drug, and has spoken publicly on the herb's safety.

The Ministry's April 2026 letter gives its reason for the root-only rule: available studies report possible safety concerns for the leaves because they hold higher concentrations of reactive withanolides, particularly withaferin-A. A product that lists leaf, or does not say which part of the plant it contains, falls outside what either authority allows.

What do trials show for stress and anxiety?

They show lower scores on stress and anxiety questionnaires than placebo, with low certainty. A 2022 meta-analysis pooled 12 randomised trials with 1,002 participants aged 25 to 48 and found that ashwagandha reduced both anxiety and stress, but the trials disagreed widely with each other and the authors graded the certainty of the evidence as low for both outcomes. A 2025 meta-analysis of 488 participants found a fall in cortisol of 1.16 micrograms per decilitre and no significant change in perceived stress scores. NCCIH's summary is that some preparations may help stress, while the evidence for anxiety is unclear.

Funding and supply deserve a line here. Much of the trial base comes from small Indian studies using one branded root extract. In the 2015 strength trial described below, the authors thank the extract's manufacturer for supplying the product, and in an often-quoted 2012 stress trial of 64 adults the extract was provided by the same company. That does not make the results wrong, but independent, larger and longer trials are still missing.

Does ashwagandha help you sleep?

Slightly, according to the one pooled analysis that has looked. A 2021 systematic review in PLoS One combined five randomised trials with 400 participants and found a small but statistically significant improvement in overall sleep. The effect was clearer in adults diagnosed with insomnia, at 600 mg a day or more of extract, and after eight weeks or longer. The review was unfunded, reported no serious side effects, and stated that data on serious adverse effects are limited and that more is needed before long-term use can be called safe.

A small effect in five short trials is a reason for modest expectations, and ashwagandha is not a sleeping pill. If late tea or coffee is part of the problem, the handbook entry on caffeine and its timing is the better starting point, and the entry on melatonin covers the other supplement people reach for at night.

What does the evidence say about strength and fitness?

There are positive trials, but the evidence is thin and close to the industry. A 2021 systematic review with a Bayesian meta-analysis found 13 studies in healthy people and pooled 12. It concluded that ashwagandha did better than placebo on measures of strength and power, cardiorespiratory fitness and recovery, with a low to moderate risk of bias, and asked for more comparable studies. The paper declares that its lead author works for a company selling an ashwagandha product. NCCIH, reading the same field, says there is not enough evidence to decide whether ashwagandha helps athletic performance.

The best-known single trial was run in India in 2015. It randomised 57 young men with little training experience to 300 mg of root extract twice a day or a starch placebo during eight weeks of resistance training. Bench press strength rose by 46.0 kg in the ashwagandha group against 26.4 kg with placebo. The authors themselves advised caution: the men were untrained, the sample was small and the study lasted eight weeks. For someone who lifts, protein intake and a sound programme matter far more, and the protein calculator and the entry on creatine deal with better-tested ground.

Reported liver injury and other side effects

The common side effects are mild. NCCIH lists drowsiness, stomach upset, diarrhoea and vomiting, and says ashwagandha may be safe when taken for up to three months, with too little information on longer use. The serious harm on record is liver injury: rare, but now described in several countries, including in people who took ashwagandha and nothing else.

The largest Indian report, published in 2023 by hepatologists from several centres, found 23 patients with liver injury linked to ashwagandha between January 2019 and December 2022 and described the 8 who had taken it as a single ingredient. Cholestatic hepatitis with jaundice and itching was the usual picture. Symptoms began a median of 41 days after starting. Five of the eight already had chronic liver disease; three of those developed acute-on-chronic liver failure and all three died. Analysis of the products found no adulteration or contamination.

The Ministry of Ayush reads the record differently. Its expert committee, chaired by a hepatologist, concluded that the studies and case reports cited by foreign agencies were inconclusive, that isolated adverse events may occur with any food or supplement, and that the evidence supports the safety of the root. The authors of the case series see a real, if uncommon, hazard. What both accounts allow is this: serious injury appears to be rare, and the people who fared worst already had liver disease.

Who should ask a doctor before taking ashwagandha?

Anyone who is pregnant, breastfeeding, living with a liver, thyroid or autoimmune condition, or taking regular medicines should not start it without medical advice. NCCIH states that ashwagandha should be avoided during pregnancy and should not be used while breastfeeding, and that it is not recommended before surgery or for people with autoimmune or thyroid disorders. This site's article on protein powders in pregnancy explains why blends with added herbs are a particular concern.

The thyroid caution has a trial behind it. In a 2018 pilot study from Varanasi, 50 adults with mildly raised TSH took 600 mg of root extract a day or a placebo for eight weeks, and TSH, T3 and T4 all changed significantly in the ashwagandha group. A herb that moves thyroid hormone levels can interfere with a carefully adjusted dose of thyroid medicine, which is why NCCIH lists thyroid hormone among the medicines it may interact with. The guide to eating with hypothyroidism covers the food questions; the tablet and any herb taken beside it are the doctor's decision.

Stop taking it and see a doctor promptly if you notice yellow eyes or skin, dark urine, persistent itching, nausea or unusual tiredness. In the published series these symptoms appeared weeks after starting, so a product that seemed harmless for the first month can still be the cause. Do not stop or change a prescribed medicine in order to try a herb in its place.

A worked example: reading a capsule label in Chennai

This case is an illustration, not a real person. Take a 34-year-old bank employee in Chennai who sleeps badly during the audit season. She has bought a bottle of 60 capsules, each labelled 600 mg of ashwagandha root extract standardised to 5 per cent withanolides, and her mother has offered home-ground root powder as well. She takes a thyroid tablet every morning.

What must an ashwagandha label show under FSSAI rules?

A product sold as a health supplement must carry the words HEALTH SUPPLEMENT, the common name of what it contains, the amount of each active substance and the advisory NOT FOR MEDICINAL USE written prominently. FSSAI's regulations also require a statement that it is not a substitute for a varied diet, and any warnings, known side effects and contraindications. The regulations prohibit implied claims of curing a disease or of drug-like efficacy, so a pack promising to fix anxiety, insomnia or a thyroid problem is breaking the rule it is sold under.

Common mistakes and myths about ashwagandha

Most mistakes come from treating all ashwagandha as one thing. People assume gram amounts of home powder are safer than a capsule because they are traditional, although the largest amounts in the Indian liver series were powders. People take it for years on the strength of trials that ran for about two months. And people stack it with other herbal blends, which makes any reaction impossible to trace.

NNWA courses that cover herbal supplements

Ashwagandha is one of the herbs examined in NNWA's Dietary Supplements and Nutraceuticals course, and its use around training comes up in Sports Nutrition. NNWA is a private skill academy in Kolkata teaching online in English and Hindi. Its courses prepare people to coach healthy clients and refer medical cases, and none is a degree or a dietitian qualification.