comparison of pomegranate peel extract capsule effect with prostabarij soft capsule in patients with benign prostate hyperplasia

Phase 3

Recruiting

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

Registration Number: IRCT20200408046990N8

Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Male

Target Recruitment: 40

Inclusion Criteria

age between 50-80 years
Mild to moderate clinical diagnosis 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, 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
concomitant use of warfarin in both group and statins except rosuvastatin, tacrolimus, and cyclosporine in pomegranate group
Patient dissatisfaction

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: Enzyme Immuno Assay.;Prostate size. Timepoint: at the beginning of the study and after 4m. Method of measurement: sonography.;Post void volume. Timepoint: at the beginning of the study and after 4m. Method of measurement: sonography.

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.