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IRCT20150420021869N6 IRCT 2023-05-14 Esfahan University of Medical Sciences Effect of Prostatan on symptoms of patients with benign prostatic hyperplasia Effect of the herbal medicine Prostatan® on lower urinary tract symptoms severity of patients with benign prostatic hyperplasia: A randomized controlled trial 2023-05-22 anticipated 80 Complete https://irct.ir/trial/69567 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients are randomly assigned to 2 control and intervention groups by random allocation software in individual units. Block randomization will be used with a block size of 6. Sealed envelopes containing a number attributed to each intervention group will be used. The patient and the practitioner are blinded to the intervention received, Blinding description: This study is a triple blind study in which the participants and the clinical caregiver and the analyzer are blind and patient group are selected by random allocation software. Randomly assigned to the case or control group (Prostatan and placebo). Then, if he is in any group, he will receive a drug that is appropriate for the group, and both pills are similar in shape. But patients and caregivers do not know which medication or placebo they received, and outcome assessors do not know the participants and record their findings based on patient numbers. 3 Benign prostatic hyperplasia. Intervention 1: Intervention group: Prostatan drug (GOLDAROU company Isfahan_Iran) will be prescribed in this group. dosage will be 1 pill every 12 hours for 3 months. Intervention 2: Control group: In this group placebo will be prescribed every 12 hours for 3 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is The data will be used in future studies.
public Farshad Gholipour
Mardavij
Isfahan Iran (Islamic Republic of) 8168814193 +98 31 3669 7898 farshad.gholipoor@gmail.com Esfahan University of Medical Sciences scientific Farshad Gholipour
Mardavij
Isfahan Iran (Islamic Republic of) 8168814193 +98 31 3669 7898 farshad.gholipoor@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Diagnosed with benign prostatic hyperplasia based on clinical diagnosis Moderate lower urinary tract symptoms due to IPSS score Age more than 40 years old 40 years no limit Male Not having consent to enter the study Patients having lower urinary tract symptoms due to other causes including ureteral stricture, prostate cancer, bladder neck cancer, bladder or ureteral stone, neurogenic bladder, or urinary tract infection Patients with liver or kidney failure D29.1 Benign neoplasm of prostate Treatment - Drugs Placebo Intervention group: Prostatan drug (GOLDAROU company Isfahan_Iran) will be prescribed in this group. dosage will be 1 pill every 12 hours for 3 months. Control group: In this group placebo will be prescribed every 12 hours for 3 months. IPSS score. Timepoint: At baseline and 3 months after intervention. Method of measurement: IPSS questionnaire. Serum PSA level. Timepoint: At baseline and 3 months after intervention. Method of measurement: Blood sampling. Esfahan University of Medical Sciences Approved 2023-04-03 Ethics committee of isfahan University of Medical Sciences Hezar-Jarib Blvd. Isfahan Isfehan Iran (Islamic Republic of)