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

A multicentre, open label, clinical trial to study the efficacy and safety of URAL- BPH in the treatment of Benign Prostate Hyperplasia.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2009/091/000021
Enrollment
Unknown
Registered
2009-01-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: URAL-BPH: Oral, one capsule, Twice a day 15 minutes before meals, 3 months Control Intervention1: NIL: NIL

Sponsors

Pace ClinServe Pvt. Ltd, 12 B, Nirmal, Nariman Point Mumbai-400021 India
Lead Sponsor

Eligibility

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
1. IPSS (International Prostate Symptom Score)Timepoint: 12 months—

Secondary

MeasureTime frame
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) Timepoint: 12 months—

Countries

India

Contacts

Public ContactMr. Bharat Shukla
amaurya@paceclinserve.com91 022 22821095

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026