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IRCT20221127056632N1 IRCT 2023-02-05 Shahid Beheshti University of Medical Sciences Zinc supplemnt in premenstruation syndrome Investigating the effect of zinc use on medical students living in the dormitories of Shahid Beheshti University of Medical Sciences with premenstrual syndrome in the Faculty of Medicine 2023-02-20 anticipated 200 Complete https://irct.ir/trial/67703 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization, individual In this way, after collecting the initial questionnaires, by a person outside the study, the owner of each questionnaire is assigned a 4-digit code that starts from 1000 consecutively. Then people with an even code enter the control group with placebo and people with an odd code enter the group supplemented with zinc, Blinding description: The study is double-blind and the participants and the researcher who dispenses the drug do not know who belongs to the control or intervention group. In this study, with the coordination of the pharmaceutical company, the placebo and the drug have been tried to be completely similar. 2-3 Premenstrual tension syndrome. Intervention 1: Intervention group: Zinc supplement users-These people are 100 people who were randomly selected and will be treated with oral zinc supplements (produced by RouaDaru pharmaceutical company and with a dose of 30 mg) for 12 weeks. Intervention 2: Control group: placebo users-According to our order to Roz Daru Company, similar to supplement pills. Yes - There is a plan to make this available What will be shared: Information related to the main outcome, including the PSST test score, can be shared. When: The access period starts 6 months after the results are published To whom: All researchers working in academic, scientific and industrial institutions can apply to receive information. Conditions: The data of this study can be used for systematic review studies and meta-analysis after the publication of the article. Where to obtain: Applicants need to send an email to the main organizer of the project at samira.z1399@gmail.com in English. How to obtain: After sending an email in English to the above address, the applicant can access the data after two working weeks. Comments:
public Samira Zallaghi
Valiasr street, before Tajrish square, Sarshar avenue, No12
Tehran Iran (Islamic Republic of) 1985717443 +98 21 5506 5547 samira.z1399@gmail.com Shahid Beheshti University of Medical Sciences scientific Samira Zallaghi
Valiasr street, before Tajrish square, Sarshar avenue, No12
Tehran Iran (Islamic Republic of) 1985717443 +98 21 5506 5547 samira.z1399@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age between 20-35 years History of regular menses at least in the last 6 months (each cycle lasts 21-35 days and the amount of bleeding is not severe and has less than 7 days of bleeding) Body mass index between 19.8 and 26 Diagnosis of premenstrual syndrome based on PSST questionnaire 18 years no limit Female Any chronic illness or psychiatric illness caused by severe PMS Receiving hormonal psychiatric drugs, supplements at the time of the study or 6 months before Smokers and vegetarians Suspected pregnancy, desire to become pregnant, current breastfeeding N94.3 Premenstrual tension syndrome Treatment - Drugs Treatment - Drugs Intervention group: Zinc supplement users-These people are 100 people who were randomly selected and will be treated with oral zinc supplements (produced by RouaDaru pharmaceutical company and with a dose of 30 mg) for 12 weeks. Control group: placebo users-According to our order to Roz Daru Company, similar to supplement pills Physical and psychological symptoms of premenstrual syndrome. Timepoint: At the beginning of the study (when sampling and before the start of the intervention) and 3 months after the start of the intervention. Method of measurement: Premenstrual Symptoms Screening Tool questionaire. Shahid Beheshti University of Medical Sciences Approved 2022-11-29 Research Ethics committee of School of Medicine - Shahid Beheshti University of Medical Sciences shahid beheshti medical university, koodakiar Ave., Arabi street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)