Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS in Treating Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 85
- 试验地点
- 5
- 主要终点
- MCS-2: To compare changes in I-PSS points after 12 weeks of MCS or placebo supplementation.
研究概览
简要总结
Phase III, Randomized, double-blind, parallel placebo-controlled study. Two arms: MCS (30mg/day) vs. placebo.
Subproject MCS-2: alpha-blocker naïve subjects
Subproject MCS-3: subjects responding poorly to alpha-blocker
详细描述
For MCS-2 This is a double-blind, randomized, placebo-controlled, parallel study where eligible male subjects (age 40, N=188), after a two-week washout period, will be randomized at 1:1 ratio to receive either MCS 30 mg/day or placebo for 12 weeks.
Group A: MCS 30 mg/day for 12 weeks Group B: placebo for 12 weeks
Subjects are limited to those who are currently not being treated medically for BPH or LUTS with alpha-blockers, anti-cholinergics, 5-alpha reductase inhibitors, or hormonal therapeutic agents. For each treatment arm, about 85 subjects eligible for final per protocol analysis will be recruited. Concerning an expected dropout rate of 10%, 188 subjects in total will be recruited onto the study.
For MCS-3 This is a double-blind, randomized, placebo-controlled, add-on, parallel study where eligible male subjects (age 40, N=242), after a two-week washout period, will be randomized at 1:1 ratio to receive either MCS 30 mg/day plus alpha-blocker or placebo plus alpha-blocker for 12 weeks.
Group A: alpha-blocker plus MCS 30 mg/day Group B: alpha-blocker plus placebo
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MCS
Group A: MCS 30 mg/day for 12 weeks
干预措施: MCS (Drug)
Placebo
Placebo, 2 capsules per day
干预措施: Placebo (Drug)
结局指标
主要结局
MCS-2: To compare changes in I-PSS points after 12 weeks of MCS or placebo supplementation.
时间窗: 12 weeks
MCS-3: To compare the percentage of subjects who achieve an I-PSS reduction by 4 or more points from baseline at 12 weeks between the MCS and the placebo arms.
时间窗: 12 weeks
次要结局
- To evaluate the general safety and tolerability.(12 weeks)