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IRCT20200408046990N4 IRCT 2020-07-29 Mashhad University of Medical Sciences 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 2020-07-22 anticipated 40 Complete https://irct.ir/trial/47484 interventional Randomization: Not randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: capsules contain pomegranate peel extract and placebo capsules will be packaged in identical-looking bottle and delivered to the clinician. Patients who meet the inclusion criteria are selected by clinician to be included in the study, randomly assigned to a drug or placebo group and given a bottle with A or B mark. Patients will be evaluated in the course of treatment by the physician and the pharmacy student. Data collection and analysis are performed by the pharmacy student and the clinical pharmacist. All of them will be unaware that A or B is on medication or placebo until the end of the study and data analysis. 3 benign prostate hyperplasia. 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 placebo capsules with same appearance of capsules contain pomegranate peel extract, including lactose, daily for 4 month. Yes - There is a plan to make this available What will be shared: The findings will be published in an article. Study protocol and statistical analysis will be used for article publication. When: One year after the end of the study it will be published and available in databases. To whom: If the funding sponsor allowed, the findings will be available for researchers, clinicians, and scientific centers. Conditions: The other researchers can use our findings in their review articles and meta analysis. Where to obtain: For this purpose, you can contact with Sepideh Elyasi, at Clinical Pharmacy Department, School of Pharmacy, Vakil Abad Aven., Mashhad, Iran. Email: elyasis@mums.ac.ir How to obtain: After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with the sponsor within 2 weeks Comments:
public Seyyed Hossein Hasheminezhad
Faculty of Pharmacy, Ferdosi University, Vakilabad Aven.
Mashhad Iran (Islamic Republic of) 17871 91886 +98 51 3851 7357 HashemiNH941@mums.ac.ir Mashhad University of Medical Sciences scientific Sepideh Elyasi
Faculty of Pharmacy, Ferdosi University, Vakilabad Aven.
Mashhad Iran (Islamic Republic of) 17871 91886 +98 51 3180 1588 elyasis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) age between 50-80 years Mild to moderate clinical diagnisis of BPH (patient has lower urinary (based on international prostate symptom score (IPSS)<18) 50 years 80 years Male 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 N40.0 Enlarged prostate without lower urinary tract symptoms Treatment - Drugs Placebo Intervention group: 3 capsules contain 250 mg of pomegranate peel extract, prepared in pharmaceutics laboratory of pharmacy school, daily for 4 month Control group:3 placebo capsules with same appearance of capsules contain pomegranate peel extract, including lactose, daily for 4 month. 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. 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. Rezvan Danesh Danial company Mashhad University of Medical Sciences Rezvan Danesh Danial company Approved 2020-04-19 Ethics committee of Mashhad University of Medical Science Qureshi Building, Daneshgah street mashhad Razavi Khorasan Iran (Islamic Republic of)