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
Amit Shrenikraj Mutha , Sonali Amit Mutha , Anupama Hem Tejuja , Amit Shashikant Beldar , Alok Mahendra Mulay , Deepak Langade
{"title":"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","authors":"Amit Shrenikraj Mutha , Sonali Amit Mutha , Anupama Hem Tejuja , Amit Shashikant Beldar , Alok Mahendra Mulay , Deepak Langade","doi":"10.1016/j.jaim.2025.101155","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Ashwagandha, a traditional Indian Ayurvedic remedy, an adaptogen, may improve sexual dysfunction in men and women.</div></div><div><h3>Objective</h3><div>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.</div></div><div><h3>Method</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":15150,"journal":{"name":"Journal of Ayurveda and Integrative Medicine","volume":"16 4","pages":"Article 101155"},"PeriodicalIF":1.7000,"publicationDate":"2025-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Ayurveda and Integrative Medicine","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0975947625000312","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"INTEGRATIVE & COMPLEMENTARY MEDICINE","Score":null,"Total":0}
引用次数: 0
Abstract
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.