# Efficacy and safety of ashwagandha root extract on sexual health in healthy Men: a prospective, randomized, double-blind, placebo-controlled study

**Authors:** Aman Khanna, Mallika Khanna, Parth Panchal

PMC · DOI: 10.3389/frph.2026.1774098 · Frontiers in Reproductive Health · 2026-02-12

## TL;DR

A clinical trial found that ashwagandha root extract significantly improved sexual function and semen quality in healthy men without safety issues.

## Contribution

This is the first placebo-controlled clinical trial to demonstrate ashwagandha's efficacy in improving male sexual health and semen parameters.

## Key findings

- ARE supplementation significantly improved sexual desire, erectile function, and sexual events compared to placebo.
- ARE increased ejaculate volume, sperm count, and sperm motility by 36%, 38%, and 87%, respectively.
- No adverse events were reported, indicating good safety and tolerability of ARE.

## Abstract

Ashwagandha (Withania somnifera) is widely recognized in Ayurvedic medicine as a potent Rasayana and aphrodisiac herb, with preclinical studies demonstrating androgen-modulating, anxiolytic, and antioxidant properties that may enhance male reproductive physiology. The present study aimed to rigorously evaluate the efficacy and safety of a standardized Ashwagandha Root Extract (ARE) in improving sexual function in healthy adult men.

A prospective, randomized, double-blind, placebo-controlled, parallel-group clinical trial was conducted over 8 weeks in 76 healthy males aged 30–50 years. Participants were randomized (1:1) to receive either 300 mg ARE twice daily or a matched placebo. Sexual functioning was evaluated using validated instruments, including the Sexual Desire Inventory-2 (SDI-2), number of Satisfying Sexual Events (SSEs), and the International Index of Erectile Function (IIEF). Semen parameters were analyzed using WHO-standardized procedures, and quality of life was assessed with the Short Form-12 Health Survey. Both intention-to-treat and safety analyses were performed with a significance threshold of α = 0.05.

ARE supplementation resulted in statistically significant improvements across multiple domains of sexual function compared with placebo, including SDI-2 scores, SSEs, sexual desire, and overall IIEF outcomes (p ≤ 0.001). Semen analysis demonstrated a 36% increase in ejaculate volume, 38% improvement in total sperm count, and an 87% increase in total sperm motility after 8 weeks, with moderate to large effect sizes indicating clinically meaningful benefits. No adverse events or safety concerns were reported.

These findings suggest that standardized ARE may serve as an effective and well-tolerated natural intervention to support male sexual health.

https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NzY3ODE=&Enc=&userName=, identifier CTRI/2,022/11/047,501.

## Full-text entities

- **Genes:** ALPP (alkaline phosphatase, placental) [NCBI Gene 250] {aka ALP, PALP, PLAP, PLAP-1}, SLC17A5 (solute carrier family 17 member 5) [NCBI Gene 26503] {aka AST, ISSD, NSD, SD, SIALIN, SIASD}, ALB (albumin) [NCBI Gene 213] {aka FDAHT, HSA, PRO0883, PRO0903, PRO1341}
- **Diseases:** inflammatory (MESH:D007249), headache (MESH:D006261), visual disturbances (MESH:D014786), Alcohol addiction (MESH:D000437), psychiatric disorders (MESH:D001523), substance abuse (MESH:D019966), malignancy (MESH:D009369), sexual dysfunction (MESH:D012735), limitation of daily activities (MESH:D020773), anxiety (MESH:D001007), Peyronie's disease (MESH:D010411), fatigue (MESH:D005221), reproductive impairments (MESH:D060737), neurological abnormalities (MESH:D009461), hypotension (MESH:D007022), spinal cord injury (MESH:D013119), flushing (MESH:D005483), Hypoactive Sexual Desire Disorder (MESH:D020018), infertility (MESH:D007246), nasal congestion (MESH:D009668), ED (MESH:D007172), M (MESH:C566367), oligospermia (MESH:D009845), penile deformities (MESH:D010409), sexual disorders (MESH:D012734), hypersensitivity (MESH:D004342), dyspepsia (MESH:D004415)
- **Chemicals:** withanolides (MESH:D054358), Bilirubin (MESH:D001663), lactate (MESH:D019344), EDTA (MESH:D004492), cortisol (MESH:D006854), bromocresol green (MESH:D001961), water (MESH:D014867), Testosterone (MESH:D013739), Ashwagandha Root Extract (-), amino acids (MESH:D000596), pNPP (MESH:C068798), starch (MESH:D013213), citrate (MESH:D019343), alcohol (MESH:D000438), creatinine (MESH:D003404)
- **Species:** Withania somnifera (ashwagandha, species) [taxon 126910], Homo sapiens (human, species) [taxon 9606]

## Full text

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## Figures

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## References

26 references — full list in the complete paper: https://tomesphere.com/paper/PMC12935928/full.md

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Source: https://tomesphere.com/paper/PMC12935928