CTRI/2009/091/000021已完成2 期
A multicentre, open label, clinical trial to study the efficacy and safety of URAL- BPH in the treatment of Benign Prostate Hyperplasia.
Pace ClinServe Pvt. Ltd,12 B, Nirmal, Nariman PointMumbai-400021India0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Age 40 and above.
- •2. PSA 4 -10 ( free PSA will be calculated, free/Total PSA ratio shall be > 0.01. In case Free/Total PSA ratio is < 0.01, then biopsy shall be done to rule cancer. If the biopsy is negative for cancer then the patient will be included in the study)
- •3. BPH diagnosed by digital rectal exam (DRE)
- •4. Prostate size diagnosed by DRE >25ml
- •5. International Prostate Symptom Score (IPSS) > 9 and < 15 (Moderate 8-19)
- •6. Urinary flow between 5-10ml/sec (with a urine Volume at least 150ml, and a post-voiding residue of <200ml)
- •7. Good mental and physical condition
排除标准
- •1. Excessively mild or severe symptoms of BPH including incontinence, Bladder distension,
- •2. Urine flow< 5mls/sec;
- •3. Bladder or prostate cancer
- •4. Previous prostate surgery
- •5. Previous radiotherapy
- •6. Serious medical co-morbidity
- •7. Urogenital infection prior treatment for BPH
- •8. Hematuria diabetes; any prior surgery which could induce dysuria
- •9. Use of any other herbal medications for treatment of BPH, associated symptoms and Erectile Dysfunction in past 1 month.
- •10. Diuretics or drugs with antiandrogenic or alpha-receptor properties in the preceding 3 months.
研究者
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