NCT03258437已完成不适用
A 12-week, Multi-center, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Allium Cepa L. and Cuscuta Chinensis Lam. Extract Mixtures (DA-9401) on Improvement of Sperm Motility
Korean Society for Sexual Medicine and Andrology2 个研究点 分布在 2 个国家目标入组 27 人开始时间: 2016年4月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Changes of Sperm motility
研究概览
简要总结
This study was conducted to investigate the effects of daily supplementation of Allium cepa L. and Cuscuta chinensis Lam. Extract Mixtures (DA-9401) on improvement of sperm motility.
详细描述
This study was a 12 weeks, multi-center, randomized, double-blind, placebo-controlled human trial. Twenty subjects were randomly divided into Allium cepa L. and Cuscuta chinensis Lam. Extract Mixtures (DA-9401) or a placebo group. sperm motility profiles before and after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 20-55 years
- •sperm motility 40~69%
排除标准
- •History of alcohol or substance abuse
- •Participation in any other clinical trials within past 1 months
- •intense constipation
结局指标
主要结局
Changes of Sperm motility
时间窗: 12 weeks
Changes of sperm profile were assessed before and after the intervention
次要结局
- Changes of Sperm count(12 weeks)
- Changes of Ejaculated pH(12 weeks)
- Changes of Sperm morphology(12 weeks)
- Changes of MFS(Multidimensional Fatigue Scale)(12 weeks)
- Changes of Ejaculated volume(12 weeks)
- Changes of hormone(Total testosterone, FSH, LH)(12 weeks)
- Changes of IIEF(International Index of Erectile Function)(12 weeks)
研究者
Park Jong Kwan
Principal Investigator, Chonbuk National University Hospital, Urology
Korean Society for Sexual Medicine and Andrology
研究点 (2)
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