A prospective, randomized double-blind, placebo-controlled study of safety and efficacy of a high-concentration…
Most of what I've read about ashwagandha traces back to one 64-person study using one company's extract — is there anything larger or independent you'd want to see first?
Suggestive but preliminary. Not settled. how we score evidence
Caveat on this rating: The paper's formal declaration reads "Source of Support: Nil" and "Conflict of Interest: None", but its own text states that the high-concentration full-spectrum extract tested "is the KSM-66 Ashwagandha extract, provided by Ixoreal Biomed, Hyderabad, India" — in-kind supply of the investigational product by its manufacturer, which is industry support whatever the declaration says. Recorded here as INDUSTRY on that basis. The trial was also not preregistered and the reported p-values are implausibly uniform across every scale.
Ashwagandha is sold in the US as a dietary supplement under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
The single most-cited ashwagandha trial: 64 adults with chronic stress took 300 mg of KSM-66 root extract twice daily or placebo for 60 days, and the extract group scored significantly lower on every stress scale (p<0.0001) with lower serum cortisol (p=0.0006). It is a 64-person, single-centre, 60-day study in people who were stressed rather than diagnosed, run on extract supplied by the company that sells it, and its results have never been replicated at scale by an independent group.
Worth asking
Most of what I've read about ashwagandha traces back to one 64-person study using one company's extract — is there anything larger or independent you'd want to see first?
Source
A prospective, randomized double-blind, placebo-controlled study of safety and efficacy of a high-concentration full-spectrum extract of ashwagandha root in reducing stress and anxiety in adults. — Chandrasekhar K, Kapoor J, Anishetty S. (2012)
Indexed peer-reviewed journal
Read the source: https://doi.org/10.4103/0253-7176.106022
DOI: 10.4103/0253-7176.106022
How this was scored
- Study design
- Randomised controlled trial
- Funding
- Industry funded
- Published in
- Indexed peer-reviewed journal
- Sample size
- 64
- Preregistered
- No
- Conflicts disclosed
- Yes
- Independent of proponent
- No
- Retracted
- No
Read the full scoring rubric, including what it can't tell you.
Published August 19, 2026.
Where we put this study in context
Questions
How strong is the evidence behind this?
Resolv rates this source "early signal". Suggestive but preliminary. Not settled. It scores 44 out of 100 on our published rubric. One caveat travels with that badge: The paper's formal declaration reads "Source of Support: Nil" and "Conflict of Interest: None", but its own text states that the high-concentration full-spectrum extract tested "is the KSM-66 Ashwagandha extract, provided by Ixoreal Biomed, Hyderabad, India" — in-kind supply of the investigational product by its manufacturer, which is industry support whatever the declaration says. Recorded here as INDUSTRY on that basis. The trial was also not preregistered and the reported p-values are implausibly uniform across every scale. The score is calculated from recorded facts about the source — study design, funding, publication venue, sample size, preregistration — not typed in by an editor.
What is the source for this?
A prospective, randomized double-blind, placebo-controlled study of safety and efficacy of a high-concentration full-spectrum extract of ashwagandha root in reducing stress and anxiety in adults. — Chandrasekhar K, Kapoor J, Anishetty S. (2012). Published in: Indexed peer-reviewed journal. DOI: 10.4103/0253-7176.106022. The full source is linked on this page so you can read it yourself.
Who paid for this research, and does that matter?
Study design: Randomised controlled trial. Funding: Industry funded. The researchers were not independent of whoever benefits from the result. Industry sponsorship is one of the most reliably measured biases in medicine, which is why funding carries real weight in the score rather than sitting in a footnote.
Is ashwagandha, withania somnifera, ksm-66, sensoril, shoden, indian ginseng, winter cherry, ashwagandha root extract FDA approved for this use?
No. Its current status is: Not FDA-evaluated for this use. Ashwagandha is sold in the US as a dietary supplement under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Is this medical advice?
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.