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

Phase 2

• Conditions: Benign Prostate Hyperplasia a nonmalignant enlargement of the prostate.

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

Brief Summary

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).

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• 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

• 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-morbidity7.
• Urogenital infection prior treatment for BPH8.
• Hematuria diabetes; any prior surgery which could induce dysuria9.
• 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: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.IPSS (International Prostate Symptom Score)	12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Nair Hospital; 🇮🇳 India, India

Sion Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Nair Hospital

🇮🇳India, India

Dr.Harish

Principal investigator

9323342361

drharishkaswan@gmail.com