CTRI/2009/091/000021未知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-400021India2 个研究点 分布在 1 个国家目标入组 0 人开始时间: 待定
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 2
- 主要终点
- 1.IPSS (International Prostate Symptom Score)
研究概览
简要总结
1.This study is A multicentre, open label, clinical trial to study the efficacy and safety of herbal medicine URAL-BPH for 12 months in 30 patients with Benign Prostate Hyperplasia that will be conducted in two center in India. The primary outcome measures will be lower IPSS (International Prostate Symptom Score) and the secondary outcome will be DRE ( Digital Rectal Examination0, Prostate Volume (by DRE), Urine flow, Bladder residual volume, IIEF, QOL, Voiding dairy and Serum Creatinine and other safety Assessment ( AE/SAE/Lab investigation).
研究设计
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
入选标准
- •Age 40 and above.
- •PSA 4 -10 ( free PSA will be calculated, free/Total PSA ratio shall be > 0.
- •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)
- •BPH diagnosed by digital rectal exam (DRE)
- •Prostate size diagnosed by DRE >25ml
- •International Prostate Symptom Score (IPSS) > 9 and < 15 (Moderate 8-19)
- •Urinary flow between 5-10ml/sec (with a urine Volume at least 150ml, and a post-voiding residue of <200ml)
- •Good mental and physical condition.
排除标准
- •Excessively mild or severe symptoms of BPH including incontinence, Bladder distension,
- •Urine flow< 5mls/sec;
- •Bladder or prostate cancer
- •Previous prostate surgery
- •Previous radiotherapy
- •Serious medical co-morbidity
- •Urogenital infection prior treatment for BPH
- •Hematuria diabetes; any prior surgery which could induce dysuria
- •Use of any other herbal medications for treatment of BPH, associated symptoms and Erectile Dysfunction in past 1 month.
- •Diuretics or drugs with antiandrogenic or alpha-receptor properties in the preceding 3 months.
结局指标
主要结局
1.IPSS (International Prostate Symptom Score)
时间窗: 12 months
次要结局
- 1. DRE (Digital Rectal Examination).2. Prostate volume (by DRE).3. Urine flow.4. Bladder residual volume.5. IIEF (International Index of Erectile Function)6. QOL ( Quality of Life).7. Voiding Dairy.8. Serum Creatinine and other safety assessment (AE/SAE/Lab investigation)(12 months)
研究者
研究点 (2)
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