A clinical trial to study the safety and efficacy of herbal medicine URAL- BPH in the treatment of Benign Prostate Hyperplasia.

Phase 2

Completed

• Registration Number: CTRI/2009/091/000021
• Lead Sponsor: Pace ClinServe Pvt. Ltd,12 B, Nirmal, Nariman PointMumbai-400021India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified