NCT00497939Unknown不适用
The Effectiveness of Saw Palmetto and Sanmiaoshan on International Prostate Symptom Score and Peak Urinary Flow Rate of Chinese Patients With Benign Prostatic Hyperplasia
Hospital Authority, Hong Kong1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2006年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Differences in IPSS between the study medication and placebo groups
研究概览
简要总结
The purpose of this study is to assess the effect of saw palmetto and sanmiaoshan, on top of alpha blocker, on urinary flow rate and BPH symptoms in patients with BPH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age between 50 and 80 years old
- •Clinically diagnosed to have BPH:
- •Suffered from lower urinary tract symptoms with IPSS>=8
- •Detectable prostatic enlargement determined by DRE
- •Urinary flow between 5 and 15ml/second in a total void volume >=150mL
- •Serum PSA level less than 4ng/ml or in between 4-10 ng/ml with percent free PSA >25% or>=4 with cancer excluded by biopsy
排除标准
- •Acute retention of urine
- •Congestive heart failure, unstable angina, arrhythmia, myocardial infraction
- •Prostatic surgery
- •Prostatic malignancy
- •Gastrointestinal disease
- •Renal impairment with serum creatinine >140 umol/l
- •Hepatic disorder
结局指标
主要结局
Differences in IPSS between the study medication and placebo groups
时间窗: At study enrolment, after six month of study medication or placebo administration, at the end of washout period and after six month of alternative drug treatment
Differences in Qmax between the study medication and placebo groups
时间窗: At study enrolment, after six month of study medication or placebo administration, at the end of washout period and after six month of alternative drug treatment
次要结局
- Differences in IPSS and Qmax at baseline and at the end of treatment drug / placebo treatment(From study enrolment/ after washout period to the end of study medication / placebo administration)
- Mean urinary flow rate, post-void residual volume, prostate volume, PSA and GHQ score between study medication group and placebo group(At study enrolment, after six month of study medication or placebo administration, at the end of washout period and after six month of alternative drug treatment)
- Mean urinary flow rate, post-void residual volume, prostate volume, PSA and GHQ score between study medication group and baseline, and placebo group and baseline(From study enrolment/ after washout period to the end of study medication / placebo administration)
研究者
研究点 (1)
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