CTRI/2022/09/046086尚未招募Phase 3 4
Evaluation of efficacy and safety of Ashwagandha (Withania) on semen quality in infertile males. A Randomised Control Trial.
Dr Md Zabihullah1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2022年3月10日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Increase in sperm count
研究概览
简要总结
The present study is a randomized, double-blind,placebo-controlled trial that aims toinvestigate the efficacy and safety of 1g Ashwagandha twice daily for 3 months on semen quality ininfertile males. It is a single-center trial evaluating 118 participants. The primary outcome measures are the changes in sperm quality parameters, viz. sperm concentration,sperm motility, and sperm vitality in infertile males following threemonths of Ashwagandha treatment as compared to three months of placebotreatment. The secondary outcome
measures are the safety of therapy underinvestigation by comparing hepatic function and renal function testsbefore and after the intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Apparently healthy males coming for semen analysis in the andrology laboratory, Department of Physiology, AIIMS, Patna
- •Age between 18-45 years
- •Males with sperm count less than 40 million /ml and more than 0.5 million/ml.
排除标准
- •Any other major comorbidities (Diabetes mellitus, hypertension etc.)
- •Males with urological diseases
- •Males on any hormonal (steroids) treatment
- •Subject taking drug known to affect semen parameters
- •Males with sperm count less than 0.5 million/ml and more than 40 million /ml.
结局指标
主要结局
Increase in sperm count
时间窗: 12 weeks
次要结局
- Increase in(1.Aspartate aminotransferase (AST))
研究者
研究点 (1)
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