Clinical study on Prostate enlargement

Phase 2/3

Completed

Conditions: Benign prostatic hyperplasia withlower urinary tract symptoms,

Registration Number: CTRI/2019/09/021386

Lead Sponsor: Welex Laboratories Pvt Ltd

Brief Summary: It is an open label, singlearm, multi-center, prospective clinical study to evaluate efficacy and safetyof WEL/ARNP01 Capsule in patients suffering from Benign Prostate Hyperplasia(BPH). The study will be conducted at three sites in India. Subjects will beadvised to take 2 WEL/ARNP01 Capsules twice daily orally after meals with waterfor 90 days. The primary objective of the study will be to assess monthly change ininternational prostate symptom score (IPSS) over three months period. The secondary objectives ofthe study will be to assess change in prostate size and weight by USG (pre andpost treatment), global assessment for overall change by the subject andinvestigator at the end of study treatment, tolerability of study drug byassessing ADRs on study completion and to assess laboratory parameters, USG andECG on study completion.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Male

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 period	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)	2.Global assessment for overall change by the subject and investigator at the end of study treatment

Trial Locations

Locations (3): Govt. Ayurved College
🇮🇳
Nanded, MAHARASHTRA, India
MAMs SS Ayurveda Mahavidyalaya and Sane Guruji Arogya Kendra
🇮🇳
Pune, MAHARASHTRA, India
S.D.M. College of Ayurveda
🇮🇳
Udupi, KARNATAKA, India
Govt. Ayurved College
🇮🇳Nanded, MAHARASHTRA, India
Dr Vijay P Ukhalkar
Principal investigator
9422171987
ukhalkarvp@gmail.com