IRCT20081011001323N32 IRCT 2025-06-08 Yasouj University of Medical Sciences Comparison of the effect of Prostanen with tamsulosin in the treatment of benign prostatic hyperplasia Comparison of the effect of Prostanen soft capsule with tamsulosin in the treatment of patients with benign prostatic hyperplasia ( Single blind randomised Clinical Trial) 2025-04-05 anticipated 128 Complete https://irct.ir/trial/82114 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization: Patients are allocated to one of two treatment groups (Prostanan capsule or Tamsulosin) using simple randomization. This is done through sealed, opaque envelopes containing treatment codes (A = Prostanan, B = Tamsulosin). Each patient randomly selects one sealed envelope at the time of enrollment, ensuring allocation concealment. This method corresponds to the well-established approach known as "Simple Randomization using sealed opaque envelopes" Blinding: The medication is dispensed by an independent researcher who is not involved in patient assessment and follows the randomization list. The person assessing patient symptoms is blinded to the treatment allocation; they only have access to the codes (A or B) without knowing which drug corresponds to each code. Patients and the drug dispenser may not be blinded, but the outcome assessor is. Thus, this is a single-blind design with blinded outcome assessors assessing the patients' symptoms. The assessors are unaware of the patients' allocation and only have access to the codes, Blinding description: In this randomised, single blind clinical trial, outcome assessors will be blinded.The medication is dispensed by an independent researcher who is not involved in patient assessment and follows the randomization list. The person assessing patient symptoms is blinded to the treatment allocation; they only have access to the codes (A or B) without knowing which drug corresponds to each code. 2-3 Benign prostatic hyperplasia. Intervention 1: Intervention group: Every night, one soft prostanen capsule was prescribed with a glass of water for two months. Intervention 2: Control group: every night, one 0.4 mg oral capsule of tamsulosin was prescribed with one glass of water for two months. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information