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IRCT20200408046990N8 IRCT 2021-09-23 Mashhad University of Medical Sciences comparison of pomegranate peel extract capsule effect with prostabarij soft capsule in patients with benign prostate hyperplasia Comparison of pomegranate peel extract oral formulation and soft capsule including Cucurbita pepo oil and vitamin E for treatment of benign prostate hyperplasia 2021-09-23 anticipated 40 Complete https://irct.ir/trial/58749 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocked randomization using website https://www.sealedenvelope.com With the explanation that each block has 4 members and the shape of the blocks can be as follows: [ABAB], [ABBA, [AABB],[BBAA],[BABA][BAAB] Code A belongs to the intervention group and code B belongs to the control group. the mentioned website selects 10 blocks from Quadruple blocks and finally 40 patients will enter the study. Allocation concealment method: Use of the central service, which consists of people who work in the center and have no knowledge of the researchers and will make a secret allocation for the research. In this method, based on the blocks created in the randomization method, a code is considered for each patient, which will be provided to the researcher at the time of patient admission by a person who has no knowledge of the process of studies and statistical analysis, Blinding description: Data will be inserted in SPSS software as A and B and after analyzing data by the analyzer the codes will be defined. 3 benign prostate hyperplasia. Intervention 1: Intervention group: 3 capsules contain 250 mg of pomegranate peel extract, prepared in pharmaceutics laboratory of Mashhad pharmacy school, daily for 4 month. Intervention 2: Control group: Prostabarij capsule including 390 mg vitamin E and Cucurbita pepo oil once daily for 4 months, standardized based on the presence of 230-200 mg of linoleic acid and 30 mg of alpha tocopherol in each soft capsule produced by barijessence company. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Sepideh Elyasi
Faculty of Pharmacy, Ferdosi University, Vakilabad Aven.
Mashhad Iran (Islamic Republic of) 17871 91886 +98 51 3851 7357 elyasis@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) Iran (Islamic Republic of) age between 50-80 years Mild to moderate clinical diagnosis 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, 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 N40.0 Enlarged prostate without lower urinary tract symptoms Treatment - Drugs Treatment - Drugs Intervention group: 3 capsules contain 250 mg of pomegranate peel extract, prepared in pharmaceutics laboratory of Mashhad pharmacy school, daily for 4 month Control group: Prostabarij capsule including 390 mg vitamin E and Cucurbita pepo oil once daily for 4 months, standardized based on the presence of 230-200 mg of linoleic acid and 30 mg of alpha tocopherol in each soft capsule produced by barijessence company. 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. 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. Mashhad University of Medical Sciences Approved 2021-09-01 Ethics committee of Mashhad University of Medical Science Qureshi Building, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)