NCT00797394已完成2 期
Efficacy of Natural Extract 2007RD01 Combined With Saw Palmetto in Benign Prostatic Hyperplasia Patients Compared to Saw Palmetto
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 8
- 主要终点
- Absolute and relative (%) change in IPSS between baseline and end of study
研究概览
简要总结
The purpose of this study is to determine if the combination of 2007RD01, a natural extract, and saw palmetto lipidic extract, is more effective at treating lower urinary tract symptoms associated with benign prostatic hyperplasia than saw palmetto lipidic extract alone.
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
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient must be an adult man aged between 50 and 75
- •Patient must have Benign Prostatic Hyperplasia symptoms
排除标准
- •Patient has a malfunction of the urinary tract, is suffering from acute urinary retention, or is suffering from prostate cancer or urinary tract infection
- •Patient has been subjected to surgery of the prostate, bladder or urethra
- •Patient has taken a 5-alpha-reductase inhibitor in the 6-month period preceding screening
- •Patient has taken an alpha-blocker in the 2-week period preceding screening
结局指标
主要结局
Absolute and relative (%) change in IPSS between baseline and end of study
时间窗: 90 days ±7 days
次要结局
- Absolute and relative (%) change in IPSS between baseline and day 30 of follow-up(30 days ±7 days)
- Absolute and relative (%) change in peak urinary flow between baseline and after 30 or 90 days of follow-up(30 days ±7 days , 90 days ±7 days)
- Absolute and relative (%) change in post-void residual volume between baseline and after 30 or 90 days of follow-up(30 days ±7 days , 90 days ±7 days)
- Change in health related quality of life between baseline and after 30 or 90 days of follow-up(30 days ±7 days , 90 days ±7 days)
- Change in sexual function between baseline and after 30 or 90 days of follow-up(30 days ±7 days , 90 days ±7 days)
研究者
研究点 (8)
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