Evaluation of the effect of oral formulation prepared from extract of pomegranate for treatment of benign prostate hyperplasia

Phase 3

Recruiting

• Conditions: benign prostate hyperplasia.; Enlarged prostate without lower urinary tract symptoms; N40.0

• Registration Number: IRCT20200408046990N4
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 August 2020

Recruitment & Eligibility

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

Inclusion Criteria

age between 50-80 years
Mild to moderate clinical diagnisis of BPH (patient has lower urinary (based on international prostate symptom score (IPSS)<18)

Exclusion Criteria

simultaneous use of BPH medications except tamsulosin
use of supplements which existing in BPH such as saw palmetto , vitamin E and Quercetin vitamins
having prostate or bladder cancer
history of prostate surgery
PSA>4mg/ml
Post void residue (PVR)=200 ml
history of allergy to pomegranate and its derivatives
use of medications with considerable metabolism through Cytochrome 3A4

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PSA serum level. Timepoint: at the beginning of the study and after 4m. Method of measurement: laboratory measurement.;Prostate size and post void volume. Timepoint: at the beginning of the study and after 4m. Method of measurement: sonography.;Clinical assessment. Timepoint: at the beginning of the study and after 2 and 4m. Method of measurement: review and physical examination.

Secondary Outcome Measures

Name	Time	Method
Adverse drug reaction assessment e.g. low blood pressure. Timepoint: at the beginning of the study and monthly. Method of measurement: review and physical examination.