Clinical study on Prostate enlargement

Phase 2

Completed

• Conditions: Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms

• Registration Number: CTRI/2019/09/021386
• Lead Sponsor: Welex Laboratories Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-03-04
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1.Subjects medically diagnosed BPH, having a minimum score of 8 on IPSS and Mild to Moderate Prostatomegaly (weight 25-70 gm) on USG study.

2.Subjects willing to follow the procedures as per the study protocol and voluntarily signing informed consent form

Exclusion Criteria

1.Subjects with clinically significant high PSA levels

2.Pharmaceutical or medical therapy for BPH or other urological symptoms, history of bladder biopsy and or cystoscopy and biopsy within the last 30 days

4.Subjects on bladder-training program, indwelling catheter or practiced self-catheterization

5.Subjects with history of urogenital surgery within the last 6 months;

6.Subjects with history of chronic persistent local pathology (i.e. interstitial cystitis, bladder stones) within the past 30 days

7.Subjects receiving/prescribed anticoagulation therapy;

8.Subjects with severe renal and/or hepatic insufficiency, known genital anatomical deformities, uncontrolled DM and uncontrolled HT, uncontrolled psychiatric disorder, abnormal secondary sexual characteristics and prostatic cancer

9.Subjects with a history of spinal cord injury, chronic alcohol and/or illicit drug abuse

10.Subjects participated in any other clinical trial during last 30 days

11.Any other condition, which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of monthly change in international prostate symptom score (IPSS) over three months periodTimepoint: Day -7, Day 0, Day 30, Day 60, Day 90

Secondary Outcome Measures

Name	Time	Method
1.Assessment of change in prostate size and weight by USG (pre and post treatment) <br/ ><br>2.Global assessment for overall change by the subject and investigator at the end of study treatment <br/ ><br>3.Tolerability of study drug by assessing ADRs on study completion <br/ ><br>4.Assessment of Laboratory parameters, USG and ECG on study completionTimepoint: Day -7, Day 0, Day 30, Day 60, Day 90