Comparison of the effect of Prostanen soft capsule with tamsulosin in the treatment of patients with benign prostatic hyperplasia ( Single blind randomised Clinical Trial)

Comparing the efficacy of prostanen and tamsulosin in the treatment of symptoms of benign prostatic hyperplasia (BPH).

In this randomized clinical trial with parallel control group, 128 patients older than 50 years suffering from benign prostate hyperplasia with sequential randomized allocation method by the help of sealed envelopes will be assigned to one of two groups (prostanen or tamsulosin) and will receive the related intervention for two months. Outcome processor 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 referring to Shahid Mofateh clinic of Yasuj suffering from benign prostatic hyperplasia who candidates for medical treatment will be assigned with sequential randomization method in one of two groups. In the first group, prostanen and in the second group, tamsulosin will be prescribed. Two months later, the patients will be re-examined, and the success of treatment measured and recorded according to symptoms and the International Prostatic Symptom Score of patients.

Inclusion criteria: Men older than 50 years old with benign prostatic hyperplasia with International Prostatic Symptom Score less than 20, signed an informed consent form Exclusion criteria: Men suffering from benign prostate hyperplasia with azotemia, active urinary tract infection, and patients with a history of herbal or medical allergy

Intervention group: In the first group, every night, one soft prostanen capsule was prescribed with a glass of water for two months. Control group: every night one 0.4 mg tamsulosin oral capsule prescribed with a glass of water for two months.

Change of symptoms of benign prostatic hyperplasia according to the International Prostatic Symptom Score criteria

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.

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.

There is no further information