CTRI/2009/091/000021
Completed
Phase 2
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 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Pace ClinServe Pvt. Ltd,12 B, Nirmal, Nariman PointMumbai-400021India
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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