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

Evaluation of the effect of oral formulation prepared from extract of pomegranate for treatment of benign prostate hyperplasia: A triple blind randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200408046990N4
Enrollment
40
Registered
2020-07-29
Start date
2020-07-22
Completion date
Unknown
Last updated
2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

benign prostate hyperplasia. Enlarged prostate without lower urinary tract symptoms

Interventions

Intervention 1: Intervention group: 3 capsules contain 250 mg of pomegranate peel extract, prepared in pharmaceutics laboratory of pharmacy school, daily for 4 month. Intervention 2: Control group:3 p

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor
Rezvan Danesh Danial company
Collaborator

Eligibility

Sex/Gender
Male
Age
50 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyyed Hossein Hasheminezhad

Mashhad University of Medical Sciences

HashemiNH941@mums.ac.ir+98 51 3851 7357

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026