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Clinical Studies Database
Ashwagandha Clinical Studies
Evidence-based summary of human clinical trials for Ashwagandha (Withania somnifera), covering stress, anxiety, cortisol, testosterone, and athletic performance outcomes.
This page summarizes peer-reviewed human clinical trials investigating the effects of ashwagandha (Withania somnifera).
Evidence Grade: B+Aliases: Withania somnifera, Indian Ginseng, KSM-66, Sensoril
Quick Answer
Ashwagandha has been evaluated in numerous randomized controlled trials investigating stress, anxiety, cortisol regulation, and physical performance outcomes. The strongest evidence supports its use for stress and anxiety, while research on testosterone, sleep quality, and athletic performance remains promising but somewhat more variable across study designs and populations.
The studies summarized below represent selected human clinical trials frequently cited in the scientific literature.
Mechanism Overview
Ashwagandha's primary bioactive compounds are withanolides (steroidal lactones), particularly withaferin A and withanolide D. These compounds are commonly discussed in relation to hypothalamic-pituitary-adrenal (HPA) axis modulation, inflammatory signaling, and neurotransmitter-related pathways.
- HPA-axis regulation is often cited as one explanation for observed stress and cortisol effects
- GABAergic and serotonergic pathways are frequently discussed in the literature
- Inflammatory markers such as NF-κB, IL-6, and TNF-α are often referenced in mechanistic discussions
- Mitochondrial and energy-related mechanisms are sometimes proposed in performance-related studies
Standardization matters: KSM-66 (root extract) and Sensoril (root + leaf extract) are among the most commonly studied commercial extract forms.
Human Clinical Trials Summary
Stress & Anxiety Reduction
| Study | Design | Dose | Duration | Key Findings | PMID |
| Chandrasekhar et al., 2012 |
RCT, n=64 |
300mg KSM-66 2x/day |
60 days |
Reduced anxiety scores and serum cortisol versus placebo in chronically stressed adults. |
23439798 |
| Lopresti et al., 2019 |
RCT, n=60 |
240mg daily (Shoden) |
60 days |
Reported reductions in stress-related outcome measures and cortisol in the active-treatment group. |
30854916 |
| Salve et al., 2019 |
RCT, n=60 |
125mg, 250mg, or 600mg/day |
8 weeks |
All dose groups showed improvement in perceived stress scores, with stronger effects at higher doses. |
32021735 |
| Auddy et al., 2008 |
RCT, n=98 |
125–500mg Sensoril |
60 days |
Reported dose-related improvements in stress-related measures and serum cortisol. |
18786858 |
Testosterone & Male Reproductive Health
| Study | Design | Dose | Duration | Key Findings | PMID |
| Wankhede et al., 2015 |
RCT, n=57 |
300mg KSM-66 2x/day |
8 weeks |
Study reported improvements in strength and recovery, with testosterone-related changes also discussed. |
26609282 |
| Ahmad et al., 2010 |
Prospective, n=75 |
5g root powder/day |
3 months |
Reported improvements in semen-related parameters in infertile men. |
19501822 |
| Lopresti et al., 2019 |
RCT, n=43 |
600mg/day |
8 weeks |
Study discussed endocrine-related changes in overweight men, including testosterone-related markers. |
30854916 |
Athletic Performance & Body Composition
| Study | Design | Dose | Duration | Key Findings | PMID |
| Wankhede et al., 2015 |
RCT, n=57 |
300mg KSM-66 2x/day |
8 weeks |
Reported greater gains in strength and recovery outcomes in the active group. |
26609282 |
| Shenoy et al., 2012 |
RCT, n=40 |
500mg aqueous extract 2x/day |
8 weeks |
Reported improvement in cardiorespiratory endurance measures. |
23125505 |
| Ziegenfuss et al., 2018 |
RCT, n=50 |
300mg Sensoril 2x/day |
12 weeks |
Reported improvements in some recovery and performance-related measures in trained participants. |
29520932 |
Sleep Quality
| Study | Design | Dose | Duration | Key Findings | PMID |
| Langade et al., 2019 |
RCT, n=60 |
300mg KSM-66 2x/day |
10 weeks |
Reported improvements in sleep quality and sleep onset measures versus placebo. |
31728244 |
| Deshpande et al., 2020 |
RCT, n=150 |
120mg Shoden |
6 weeks |
Study reported improvements in sleep-related measures in the active-treatment group. |
32540634 |
Dosages Used in Studies
KSM-66 (Root Extract)
- Stress/anxiety studies commonly used 300mg 2x/day
- Sleep-related studies often used similar daily totals
- Performance-related studies also frequently used divided dosing
Sensoril (Root + Leaf)
- Stress-related studies used lower to moderate daily doses
- Some performance-related studies used divided daily dosing
Shoden / High-Withanolide Extracts
- Sleep/stress studies used lower total daily doses
Unstandardized Preparations
- Root powder and aqueous extracts have also been studied
Safety & Contraindications
Ashwagandha is generally well tolerated in many clinical studies, though tolerability can vary by dose, extract type, and individual health context.
- Common side effects: Mild gastrointestinal discomfort, drowsiness, or digestive upset
- Clinical cautions: Thyroid-related effects and medication interactions are sometimes discussed in the literature
- Pregnancy / autoimmune context: Extra caution is commonly advised
Note: Rare case reports have discussed possible liver-related adverse events. People with liver conditions or complex medical histories should consult a qualified healthcare professional.
Evidence Summary
- Stress / Anxiety: Strong evidence (Grade A−) — Multiple randomized trials support benefit in stress-related outcomes.
- Sleep Quality: Moderate evidence (Grade B) — Controlled trials suggest potential benefit, though not all extracts and populations are identical.
- Athletic Performance: Moderate evidence (Grade B) — Some trials suggest improvements in strength, recovery, or endurance-related outcomes.
- Testosterone / Male Reproductive Health: Moderate evidence (Grade B−) — Findings are promising but should be interpreted cautiously across populations and endpoints.
- Cognitive / Broader Health Outcomes: Preliminary evidence (Grade C) — More rigorous replication is needed.
References
- Chandrasekhar K, Kapoor J, Anishetty S. 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. Indian J Psychol Med. 2012;34(3):255-262. PMID: 23439798
- Lopresti AL, Smith SJ, Malvi H, Kodgule R. An investigation into the stress-relieving and pharmacological actions of an ashwagandha (Withania somnifera) extract. Medicine (Baltimore). 2019;98(37):e17186. PMID: 30854916
- Salve J, Pate S, Debnath K, Langade D. Adaptogenic and Anxiolytic Effects of Ashwagandha Root Extract in Healthy Adults. Cureus. 2019;11(12):e6466. PMID: 32021735
- Wankhede S, Langade D, Joshi K, et al. Examining the effect of Withania somnifera supplementation on muscle strength and recovery. J Int Soc Sports Nutr. 2015;12:43. PMID: 26609282
- Ahmad MK, Mahdi AA, Shukla KK, et al. Withania somnifera improves semen quality by regulating reproductive hormone levels and oxidative stress. Fertil Steril. 2010;94(3):989-996. PMID: 19501822
- Shenoy S, Chaskar U, Sandhu JS, Paadhi MM. Effects of eight-week supplementation of Ashwagandha on cardiorespiratory endurance. J Ayurveda Integr Med. 2012;3(3):111-114. PMID: 23125505
- Langade D, Kanchi S, Salve J, et al. Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract in Insomnia and Anxiety. Cureus. 2019;11(9):e5797. PMID: 31728244
- Ziegenfuss TN, Kedia AW, Sandrock JE, et al. Effects of an Aqueous Extract of Withania somnifera on Strength Training Adaptations and Recovery. Nutrients. 2018;10(11):1807. PMID: 29520932
Last updated: March 2026. This page summarizes published peer-reviewed research and is not medical advice. Consult a healthcare provider before starting any supplement.