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IRCT20140926019295N4 IRCT 2024-04-09 Shiraz University of Medical Sciences Evaluation of the effects of Tamarind seed extract product (Tamarindus indica L.) with Sertraline in treatment of premature ejaculation Comparison of the effects of Tamarind seed extract product (Tamarindus indica L.) with Sertraline in treatment of premature ejaculation 2024-04-20 anticipated 40 Complete https://irct.ir/trial/76268 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is simple randomization. The randomization unit is individual and the patient randomization tool is a table of random numbers using with computer. The starting point was completely random (choosing a number on the table with eyes closed) and choosing the direction of movement in the table in the downward direction. Patients are randomly placed in one of the study groups with the help of a random number table and receive the relevant intervention, Blinding description: The outcome evaluator and the statistical analyst of the results will be blinded. The capsules of the drug and the standard drug have the same shape, and after being filled, they are packed in packages of 30 pieces that are completely similar in terms of shape. Only the researcher can decipher the contents of each capsule package based on the initial form stored of the randomization results. The person responsible for delivering the medicine, the patient, the doctor, the person responsible for evaluating the results will not know about the coding. The results of group therapy and intervention will be delivered to the statistical analyst under the titles of groups A and B. 3 Premature ejaculation. Intervention 1: Tamarind seed capsule is standardized to contain at least 80 mg of active ingredient, it will be consumed once a day for one month, this drug is made by Dayan Teb Elixir Company. Intervention 2: Sertraline 50 mg will be taken once a day for one month, manufactured by Octorco pharmaceutical company. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is A decision will be made according to the cooperation of relevant sources.
public Payam Sadeghi
Chamran Blv. Hafez hospital- psychiatry department
Shiraz Iran (Islamic Republic of) 7144734189 +98 71 3647 9531 payamsadeghi68@gmail.com Shiraz University of Medical Sciences scientific Ali Sahraian
Department of Psychiatry, Hafez Hospital ,Shiraz University of Medical Sciences
Shiraz Iran (Islamic Republic of) 7144734189 +98 71 3647 9531 sahraian@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Being monogamous and married for at least 6 months ago age between 50-20 years old PEDT questionnaire score greater than 8 Written and informed consent to participate in the study 20 years 50 years Male Use of treatments outside the study protocol ulcerative colitis; Chronic constipation, digestive discomfort, kidney cleansing, high blood pressure Not being able to accurately measure the IELT score Chronic and permanent use of any type of psychoactive drug or any type of narcotic drug F52.4 Premature ejaculation Treatment - Drugs Treatment - Drugs Tamarind seed capsule is standardized to contain at least 80 mg of active ingredient, it will be consumed once a day for one month, this drug is made by Dayan Teb Elixir Company. Sertraline 50 mg will be taken once a day for one month, manufactured by Octorco pharmaceutical company. Time of Ejaculation ( From Vaginal Entrance to Ejaculation ). Timepoint: The Time of Ejaculation at the Beginning of the Study ( Before the Intervention) and 4 weeks after the start of Drug. Method of measurement: Measure the time in seconds by the stopwatch by the patient's wife. Shiraz University of Medical Sciences Approved 2024-03-02 Ethics committee of Shiraz University of Medical Sciences Karim Khan Zand St. Faculty of Medicine Shiraz Fars Iran (Islamic Republic of)