Evaluation of Prostacare EF (Excipient free)In benign prostatic enlargment

Phase 2/3

Completed

• Conditions: Benign prostatic hypertrophy

• Registration Number: CTRI/2011/06/001797
• Lead Sponsor: The Himalaya Drug Company

Brief Summary

Male subjects aged between 40 to 60 years with Benign Prostatic Hypertrophy diagnosed on the basis of mildto moderate symptoms of urinary obstruction, decreased maximal urinary flowrates and an enlarged prostate gland on digital rectal examination will beselected for a double-blind-placebo controlled study.  The aim of this study is to evaluate theefficacy of Prostacare EF in BHP.

Allpatients satisfying inclusion criteria will be enrolled in this study.  Men will be randomly assigned to receive 2Capsule of Prostacare EF or placebo twice daily according to the randomisationchart.  All the patients will bemonitored at monthly interval for 3 months. They will be evaluated for symptoms and urinary flow rates every month.

The primary end point, the symptom score will bemeasured by American Urological Association (AUA) symptom score.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-06
• Last Update Posted: 2013-07-02

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

Males between 40-60 years of age suffering from benign prostatic hypertrophy.

Exclusion Criteria

Males less than 40 years old are excluded from the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in the symptoms of BPH as measured by American Urological Association (AUA) symptom score.	3 months

Secondary Outcome Measures

Name	Time	Method
Assessment of long term safety of the study drug.	3 months

Trial Locations

Locations (1)

Shubhdeep Ayurved Medical College; 🇮🇳 Indore, MADHYA PRADESH, India

Shubhdeep Ayurved Medical College

🇮🇳Indore, MADHYA PRADESH, India

Dr A K Singh

Principal investigator

08022169999

doctoraksingh@yahoo.com