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

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.