RPCEC00000138尚未招募3 期
Comparative study of medium-term effects of D-004 and Saw palmetto (320 mg / d) in patients with benign prostatic hyperplasia (BPH)
atural Products Center (CPN)0 个研究点目标入组 100 人开始时间: 2013年1月4日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial. Masking: Double Blind. Control group: Active. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 50 years 至 /A (No limit)（—）
- 性别
- Male
入选标准
- •1. Patients with 50 years old or older 2. Informed consent 3. IPSS score between 7 and 19 4. Enlarged prostate checked by rectal examination
排除标准
- •1. Prostate Cancer 2. Prior urological surgery 3. Urinary retention 4. Urinary tract infection 5. Criteria to be catheterized in next 3 months 6. PSA> 5 ng / mL 7. Acute myocardial infarction, stroke, transient ischemic attack or major surgery within 6 months previous 8. History of heart failure 9. History of hepatic failure 10. Blood Pressure > 180/110 mm Hg 11. Diagnosed neoplasias 12. Treatment with alpha 1 adrenergic antagonists, inhibitors of 5-alpha reductase, androgens,antiandrogens, cholinergics, anticholinergics,steroids and/or phytotherapy for BPH in 6 months prior study 13. Alcoholism 14. Other problems that limit its response to IPSS 15. Common history of drug allergy or any other condition that affects patient´s health and life during the study
研究者
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