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

Ashwagandha, a traditional Indian Ayurvedic remedy, an adaptogen, may improve sexual dysfunction in men and women. 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 based on 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) using the SF-12 tool. A total of 100 healthy men aged 30 to 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 were done 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. 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.