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.
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