Los Angels, CA—Two new published studies are taking a look at the effects of ashwagandha (Withania somnifera) on healthy adult men. Researchers set out to determine if an eight-week therapy with Ashwagandha Root Extract (ARE) could lead to a significant improvement of male fertility, sexual wellness, and testosterone. In a separate study, researchers conducted a prospective, randomized, double-blind, placebo-controlled observational study on the safety of administered Ashwagandha Standardized Root Extract based on the incidence of treatment-emergent adverse events (TEAEs) over 12-months in healthy adults.
Analyzing the results
From their findings, industry experts were able to determine:
- The long-term safety, tolerability, and quality-of-life benefits of daily Ashwagandha root extract use for one full year
- KSM-66 demonstrated a significant improvement in serum testosterone and dihydrotestosterone levels, semen volume, sperm count, and sperm motility
Particulars of each study include:
Study: Long-Term Safety of Ashwagandha in Healthy Adults
- Study Dose: 600 mg/day
- Study Duration: 12 months
- Number of Participants: 191
Results
- Liver function markers (ALT, AST, ALP, bilirubin) remained clinically stable with no hepatotoxicity signal
- Renal parameters (creatinine, BUN) remained within normal limits
- Thyroid function parameters (TSH, T3, T4) remained unaffected
- Serum cortisol levels decreased significantly (p < 0.001)
- SF-12 Quality of Life scores improved significantly at 12 months (p < 0.001)
Participants were also evaluated for:
- The effects of long-term Ashwagandha supplementation on hepatic safety parameters (ALT, AST, ALP, bilirubin).
- Renal safety parameters (serum creatinine, BUN).
- The effect on thyroid function (TSH, T3, T4).
- Changes in serum cortisol levels, serum testosterone (free and total), changes in health-related quality of life (SF-12), and overall clinical improvement using CGI-I scale.
Study: Male Fertility, Sexual Wellness, and Testosterone in Men
- Number of Participants: 93
- Duration: 8 Weeks
- Dose: 300mg / twice daily
Results
Mutha et al (2025) investigated the effects of KSM-66 Ashwagandha root extract (300mg twice daily) on 93 healthy participants over 8 weeks. In addition, there was a significant improvement in the level of sexual desire scores, number of satisfying sexual events, International Index of Erectile Function scores, and improvement in overall quality of life:
- A 14.3% and 10.43% increase in Serum Testosterone and Dihydrotestosterone levels, respectively (p<0.05).
- A 26.4%, 32.14%, and 37.58% increase in Semen Volume, Sperm Count, and Sperm Motility parameters, respectively.
- A 112.84% and 108.12% increase in the Level of Sexual Desire scores and Number of Satisfying Sexual Event scores, respectively.
- The International Index of Erectile Function domain scores for Erectile Function, Orgasmic Function, Sexual Desire, and Intercourse Satisfaction improved significantly by 12.11%, 19.03%, 31.53%, and 29% respectively. The total IIEF score improved by 18.23%.
- A 15.52% increase in Short Form-12 Questionnaire scores for quality of life.
Complete details of the studies can be found here:
- Efficacy and safety of eight-week therapy with Ashwagandha root extract in improvement of sexual health in healthy men: Findings of a prospective, randomized, double-blind, placebo-controlled study
- Safety of 12-Months Administration of Ashwagandha (Withania somnifera) Standardized Root Extract in Healthy Adults: A Prospective, Observational Study







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