To compare the efficacy and safety of tadalafil plus finasteride versus tadalafil plus dutasteride in treatment of symptomatic benign prostatic hyperplasia.
Phase 3
- Conditions
- Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
- Registration Number
- CTRI/2023/08/056028
- Lead Sponsor
- Pt B.D. Sharma UHS Rohtak
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients above 65 years of age.
2. History of lower urinary tract symptoms/benign prostatic hyperplasia for the last 6 months.
3. International Prostate Symptom Score = 13.
4. Prostate volume = 30 ml.
Exclusion Criteria
1. Patients having hypertension, coronary artery disease, cardiac arrhythmias.
2. Patients diagnosed as a case of carcinoma prostate.
3. Patients with hepatic function impairment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Decrease in total International Prostate Symptom ScoreTimepoint: At 0 week 4 weeks & 8 weeks
- Secondary Outcome Measures
Name Time Method -IPSS Quality of life index score <br/ ><br>-IPSS storage subscore <br/ ><br>-IPSS voiding subscore <br/ ><br>-Decrease in prostate volume <br/ ><br>-Decrease in post voidal residual volumeTimepoint: At 0 week 4 weeks & 8 weeks