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IRCT20170807035551N2 IRCT 2021-01-16 Urology Research Center of Tehran University of Medical Sciences Efficacy of Tadalafil on improvement of erectile dysfunction Efficacy of Tadalafil on improvement of erectile dysfunction caused by Covid 19 2021-01-20 anticipated 60 Complete https://irct.ir/trial/53252 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals are divided into two groups of intervention and control by simple randomization by a table of random numbers. In order to hide random allocation, the method of sealed envelopes is used, in which the type of treatment for each patient is written as even or odd numbers on a piece of paper and is placed in a sealed envelope. After the visit, an envelope is randomly removed for each patient. Doctors and patients do not know the type of treatment, Blinding description: This is a double blind study. Physician take an envelope, respectively which is blind to the patient's assigned group. According to the assigned number (odd or even numbers), the relevant drug of its therapeutic line is given to the patient. The researcher records the delivered drug code. Patients are also unaware of their treatment group. After completion of the treatment and collecting the data, the analyzer analyzes the data based on their code (odd or even). Evaluators and analyzer will be unaware of the intervention and control groups. 3 Erectile dysfunction. Intervention 1: Intervention group: Prescribing Tadalafil 10 mg tablets from Rouzdarou company daily 1 tablet after lunch for 2 months.(A total of 60 capsules, each containing a 10 mg tablet of Tadalafil, are prescribed to the patient). Intervention 2: Control group: Prescribe placebo 1 tablet daily after lunch for 2 months.(A total of 60 capsules similar to the intervention group, each containing 10 mg of placebo, are prescribed to the patient). Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals. When: starting 6 months after publication To whom: only available for people working in academic institutions Conditions: Data will be available for re-analysis and also for use in meta-analysis Where to obtain: imanshamohammadi@yahoo.com Iman Shamohammadi 09365738466 How to obtain: Inform the responsible person via email and after coordination with Dr.Kazemeyni, the data will be available. Comments:
public Iman Shamohammadi
North Kargar St, Shariati Hospital, Urology Department
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 shariatihosp@tums.ac.ir Tehran University of Medical Sciences scientific Iman Shamohammadi
North Kargar St, Shariati Hospital, Urology Department
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 shariatihosp@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Erectile dysfunction after recovery from C0VID19 Men between the ages of 30 and 50 Obtaining patient consent 30 years 50 years Male History of erectile dysfunction before COVID19 History of trauma or anatomical problems in the penis A history of neurological disorders including spinal cord injury, stroke, and migraine History of heart disease History of taking mineral nitrate drugs N52 Male erectile dysfunction Treatment - Drugs Treatment - Drugs Intervention group: Prescribing Tadalafil 10 mg tablets from Rouzdarou company daily 1 tablet after lunch for 2 months.(A total of 60 capsules, each containing a 10 mg tablet of Tadalafil, are prescribed to the patient) Control group: Prescribe placebo 1 tablet daily after lunch for 2 months.(A total of 60 capsules similar to the intervention group, each containing 10 mg of placebo, are prescribed to the patient) Measuring the severity of erectile dysfunction. Timepoint: before intervention, two months after intervention. Method of measurement: International index of erectile function questionnaire. Sexual satisfaction of patient. Timepoint: before intervention, two months after intervention. Method of measurement: International index of erectile function questionnaire. Intensity of sexual desire. Timepoint: before intervention, two months after intervention. Method of measurement: International index of erectile function questionnaire. Complications of drug administration. Timepoint: During the intervention and two months after the start of the intervention. Method of measurement: Based on questions from the patient. Urology Research Center of Tehran University of Medical Sciences Approved 2020-12-20 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Pour Sina alley, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)