Efficacy and Safety of Ashwagandha (Withania Somnifera ) Root Powder on Male Sexual Health: A Double-Blind Randomized Placebo-Controlled Study
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Improvement in any of the following questionnaire score.
研究概览
简要总结
Sexual health is stated as " a state of physical , emotional, mental, and social well being concerning sexuality". With the rapid pace of human development, many factors such as stress, anxiety, depression, socio-economic burden, impaired lifestyle have reported a sharp uptick year on year, especially in young adults which leads an increase in the number of cases of male sexual dysfunction.in the past two years of COVID-19 pandemic, it has been observed that the number of cases of anxiety, fear, stress have multiplied which cause sexual inefficiency. Therefore, there is a need to validate the effect of interventional modalities which enhance male sexual wellness.
In this study two groups will be formed randomly. One group will be administered Ashwagandha root powder in dosage of 3 gms bid with milk after meal and other group will be administered Roasted wheat flour in dosage of 3gms bid. The effect of both will be compared with the help of subjective and objective parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male patient Aged ≥20 to ≤ 50 years.
- •Subject satisfying any one of the following criteria.
- •â€¢ Subject having Erectile dysfunction IIEF A Score in between 11-
- •â€¢ Premature Ejaculation IPE Score in between 18-
- •â€¢ Other Sexual dysfunction IIEF B Score in between 21-
- •Not suffering from any chronic disease.
- •Patients have common medical co-morbidities.
- •â€¢ Controlled hypertension (≤140/90 mm/hg) • Controlled diabetes (FBS≤126mg/dl/ PP≤200mg/dl or HbA1c between 6-6.9 %).
排除标准
- •History of hypothyroidism, cardiovascular disease, psychiatric disorders.
- •Participants addicted to smoking, tobacco and alcohol consumption.
- •Subject under treatment for the male infertility.
- •Anatomical deformity of the penis such as severe penile fibrosis or Peyronie’s disease or phimosis.
- •Subjects suffering from congenital anomalies.
- •Subjects who underwent major surgical procedures in last 6 months.
- •Subjects with any unstable heart disease or known case of MI, Unstable angina.
- •Subjects who have completed participation in any other clinical trial during the past six month.
结局指标
主要结局
Improvement in any of the following questionnaire score.
时间窗: 30 days
a) International Index of Erectile function subscale A
时间窗: 30 days
b) International Index of Erectile function subscale B
时间窗: 30 days
c) Index of Premature Ejaculation
时间窗: 30 days
次要结局
- The secondary outcome is the improvement in the semen parameters and serum(testosterone level from baseline (day 0) after 30 days of therapy.)