Study2025Open access

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

Mutha AS, Mutha SA, Tejuja AH, Beldar AS, Mulay AM, Langade D

Journal of Ayurveda and integrative medicine · 2 citations

How it was studied

Design
Randomized controlled trial (classified by our AI screen)
Studied in
People
Main outcome
Health markers and function

Who paid for it

Funding
Independent funding

Based on full-text disclosure statement.

Publication

Published
2025-07-01 · J Ayurveda Integr Med · vol. 16 · issue 4 · p. 101155
Publisher
Elsevier BV
Cited
7 citations · more than 97% of similar papers · 8.0× the field average
Impact
Top 10% most cited in its field
References
41 works
Access
Open access (journal) · CC-BY-NC-ND
Research areas
Phytochemicals and Medicinal Plants · Phytochemistry and Bioactive Compounds · Complementary and Alternative Medicine Studies
Keywords
Medicine, Placebo, Double blind, Randomized controlled trial, Physical therapy, Traditional medicine, Internal medicine, Alternative medicine

6 authors

From IN

  • Amit Shrenikraj Mutha · correspondingGrant Medical College and Sir Jamshedjee Jeejeebhoy Group of Hospitals
  • Sonali Amit Mutha
  • Anupama Hem Tejuja
  • Amit Shashikant BeldarDr. D. Y. Patil Medical College, Hospital and Research Centre
  • Alok Mahendra MulayGrant Medical College and Sir Jamshedjee Jeejeebhoy Group of Hospitals
  • Deepak LangadeD.Y. Patil University

Abstract

Background

Ashwagandha, a traditional Indian Ayurvedic remedy, an adaptogen, may improve sexual dysfunction in men and women.

Objective

This 8-week prospective, double-blind, randomized, placebo-controlled study evaluated the efficacy and safety of Ashwagandha Root Extract (ARE) on improving sexual health in healthy adult men.

Method

A total of 100 healthy men aged 30-50 years were randomly assigned to receive ARE 300 mg twice daily (n = 50), or identical placebo (n = 50) in a 1:1 ratio for 8 weeks. Study assessments such as Satisfying Sexual Events (SSEs), the Sexual Desire Inventory (SDI-2), the International Index of Erectile Function (IIEF) score, semen parameters and the Quality of Life (QOL) were done using the SF-12 tool at baseline, week 2, week 4, and week 8. Three participants from ARE and four participants from the placebo group were excluded due to follow-up loss. The efficacy analyses were done on Per-Protocol (PP) dataset of 93, whereas safety analyses were done on all 100 participants.

Results

Significant improvements were observed with ARE for semen volume (p = 0.005), sperm number (p = 0.006), sperm concentration (p = 0.007), and sperm morphology (p = 0.007). The improvement in scores was better with ARE for SDI-2 (p < 0.05), orgasm and sexual desire domains of IIEF (p < 0.05), and SF-12 (p < 0.0001). No adverse events were reported in the study.

Conclusion

Ashwagandha improved the orgasmic function, sexual desire and overall sexual satisfaction with the 8-week of oral administration. It was well tolerated as it showed no significant changes in hepatic and renal parameters in blood.

Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC-ND).

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