The Study
Safety of 8-Week Administration With Ashwagandha (Withania somnifera) Root Extract in Adults With Stress and Anxiety: Findings From a Prospective, Randomized, Multi-Center, Double-Blinded, Placebo-Controlled Study.
This study is like a test to see if a new medicine (Ashwagandha) is safe to take. It gave half the people the real medicine and half a fake pill (placebo) and watched for any bad side effects. The study found that the real medicine didn't cause more problems than the fake pill, so it seems safe for 8 weeks. But this study doesn't tell us if the medicine actually helps with stress or anxiety – that's a different question.
Analysis score
Maximum 90 for a randomized controlled trial.
Where the score came from
Scientists gave 1002 people either ashwagandha or a fake pill for 8 weeks and checked for side effects and blood tests.
Where does this study sit?
Reviews of RCTs (Meta-analyses)
Max 100Randomized Trials
Max 90Reviews of Cohort Studies
Max 85Cohort Studies
Max 72Reviews of Case-Control Studies
Max 63Case-Control Studies
Max 58Cross-Sectional & Case Series
Max 50Expert Opinion
Max 580 / 100
Quality score
Participants are randomly assigned to treatment or control groups, minimizing bias. The gold standard for testing whether an intervention causes an effect.
Key takeaways
Summary
Based on the study abstract and findings.
- 1The study shows that taking ashwagandha for 8 weeks is as safe as taking a placebo, with no important changes in health measures.
- 2Both groups had similar mild side effects like nausea (2% ashwagandha vs.
- 33.2% placebo), dry mouth (1.4% both), and headache (0.2% vs.
- 42.2%).
- 5No serious problems occurred.
- 6Blood tests (liver, kidneys, blood cells) stayed normal.
Score breakdown, methodology, conflicts of interest, evidence analysis & raw study data
Publication
Journal
Phytotherapy research : PTR
Year
2026
Authors
K. Pakhale, J. Salve, John Ademola, J. Parraca, Deepak Langade
Related Content
Claims (8)
Taking KSM-66 ashwagandha root extract in gummy form for eight weeks does not cause significant adverse effects in most people.
In adults with stress and anxiety taking 600 mg of Ashwagandha root extract daily for 8 weeks, the most common side effects are nausea in 2% of people, dry mouth in 1.4%, and headache in 0.2%. These side effects are mild to moderate and go away on their own.
In a large study, adults with mild-to-moderate stress and anxiety took 600 mg of ashwagandha root extract daily for 8 weeks. No serious side effects were reported in either the ashwagandha group or the placebo group.
Taking 600 mg of Ashwagandha root extract daily for 8 weeks did not cause significantly more side effects than a placebo in adults with stress and anxiety. The rate of side effects was actually slightly lower with Ashwagandha (5.6%) than placebo (9.2%), but this difference was not large enough to be considered meaningful.
Taking 600 mg of Ashwagandha root extract daily for 8 weeks does not significantly alter liver enzyme levels (AST and ALT) in adults with stress and anxiety. Both the supplement and placebo groups maintained normal liver function throughout the study.
Taking Ashwagandha root extract (600 mg per day for 8 weeks) does not cause any meaningful changes in kidney function in adults with stress and anxiety. Kidney function, measured by a blood test called serum creatinine, stays normal and is the same as in people taking a placebo.
Not medical advice. For informational purposes only. Always consult a qualified healthcare professional before making health decisions.