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

IF 1.7 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE
Amit Shrenikraj Mutha , Sonali Amit Mutha , Anupama Hem Tejuja , Amit Shashikant Beldar , Alok Mahendra Mulay , Deepak Langade
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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.
Ashwagandha根提取物8周治疗改善健康男性性健康的疗效和安全性:一项前瞻性、随机、双盲、安慰剂对照研究的结果
阿什瓦甘达,一种传统的印度阿育吠陀疗法,一种适应原,可以改善男性和女性的性功能障碍。目的:这项为期8周的前瞻性、双盲、随机、安慰剂对照研究评估了Ashwagandha根提取物(ARE)改善健康成年男性性健康的有效性和安全性。方法100名30-50岁的健康男性随机分为两组,分别以1:1的比例接受are300 mg每日两次(n = 50)或相同的安慰剂(n = 50),持续8周。在基线、第2周、第4周和第8周使用SF-12工具进行研究评估,如满意性事件(sse)、性欲量表(SDI-2)、国际勃起功能指数(IIEF)评分、精液参数和生活质量(QOL)。由于随访缺失,ARE组的3名参与者和安慰剂组的4名参与者被排除在外。疗效分析是在93人的Per-Protocol (PP)数据集上进行的,而安全性分析是在所有100名参与者身上进行的。结果ARE组患者的精液体积(p = 0.005)、精子数量(p = 0.006)、精子浓度(p = 0.007)、精子形态(p = 0.007)均有显著改善。SDI-2的评分改善在ARE组更好(p <;0.05),性高潮和性欲域(p <;0.05), SF-12 (p <;0.0001)。本研究未报告不良事件。结论口服8周后,阿什瓦甘达能改善患者的性功能、性欲和总体性满意度。由于血液中肝脏和肾脏参数没有明显变化,因此耐受性良好。
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来源期刊
Journal of Ayurveda and Integrative Medicine
Journal of Ayurveda and Integrative Medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-
CiteScore
4.70
自引率
12.50%
发文量
136
审稿时长
30 weeks
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