A Clinical Study to Evaluate the Safety and Efficacy of Capsule Outflo in Patients with Benign Prostatic Hyperplasia
- Conditions
- Health Condition 1: null- Benign Prostatic Hyperplasia
- Registration Number
- CTRI/2012/10/003049
- Lead Sponsor
- Sahajanand Life Sciences Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 75
•Male patients with aged >=40
•New patients diagnosed with BPH, naïve to any other treatments for BPH
•Patients with International Prostate Symptom Score (IPSS) greater than 7 and less than 18
•Patients with Prostate volume less than 40 cc
•Patients with Qmax of 8-12 ml/sec
•Patients with PVUR less than 200 ml
•Patients willing to give written informed consent and willing to follow up
•Patients with prostatic cancer; neurogenic bladder; bladder cancer; bladder stones; urethral strictures; neurological conditions that might interfere with normal voiding
•Symptomatic coronary arterial disease, stroke, and cardiovascular events
•Current treatment with systemic corticosteroids or herbal (alternative) medicines
•Patients with abnormal renal and hepatic function
•Any significant disease or disorder that may jeopardize the safety of the subject
•Patients with drug and alcohol abuse
•Any psychiatric disorder
•Patients who have participated in any clinical trial in the past 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in International Prostate Symptom Score (IPSS) <br/ ><br> <br/ ><br>Change in Uroloflowmetry parametersTimepoint: Change in International Prostate Symptom Score (IPSS)(baseline - 1 month - 2 months - 3months) <br/ ><br> <br/ ><br>Change in Uroflowmetry parameters (baseline - 1 month - 2 months - 3months)
- Secondary Outcome Measures
Name Time Method Change in Prostate VolumeTimepoint: Baseline - End of Study