ISRCTN18705154已完成未知
Double-blind, randomized, parallel-group, monocentric, placebo-blind study of the effect of an extract of Epilobium angustifolium L. with high oenothein B content on benign prostatic hypertrophy (BPH)
EPO Srl0 个研究点目标入组 128 人开始时间: 2020年6月19日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 128
研究概览
简要总结
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33765581/ (added 13/08/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Aged over 45
- •2. No clinically significant deviation in laboratory tests
- •3. History of mild BPH for at least 1 year
- •4. Pharmacologically treated but not controlled BPH
- •5. IPSS score = 8 and = 19 (moderate symptoms)
- •6. Prostate volume = 25cc and = 70cc
- •7. PVR between 30 ml and 200 ml
- •8. PSA = 4 ng/ml
排除标准
- •1. Acute or chronic disease that could interfere with the study or dangerous for the participant
- •2. Use of any of the following concomitant drugs: immunosuppressants, anticoagulants, a-blockers, 5a-reductase inhibitors, antipsychotics, chemotherapy drugs, drugs for dementia, male hormone replacement therapy and drugs for overactive bladder, atonic and/or neurogenic bladder
- •3. Bladder neck contracture
- •4. Acute prostatitis; bladder calculosis: urinary tract infection more than once in the last 12 months
- •5. Prostate or bladder cancer; history of pelvic trauma or surgery; clinically significant kidney or hepatic insufficiency
- •6. Microscopic hematuria that was not evaluated by a urologist and not attributed to BPH
- •7. Any condition that might interfere with the subject's ability to give informed consent, to comply with study instructions, to provide an objective evaluation of his or her symptoms, or that might confuse the interpretation of study results
- •8. Those considered unsuitable for the participation by the physician
研究者
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