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

Introduction 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. Methods 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. Results 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. Discussion These findings suggest that standardized ARE may serve as an effective and well-tolerated natural intervention to support male sexual health. Clinical Trial Registration https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NzY3ODE=&Enc=&userName= , identifier CTRI/2,022/11/047,501.