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IRCT20210614051574N12 IRCT 2022-06-22 Hamedan University of Medical Sciences Zinc supplementation and chronic pelvic pain syndrome Evaluation of the effect of zinc supplementation in treatment of patients with chronic pelvic pain syndrome 2022-07-22 anticipated 60 Complete https://irct.ir/trial/64157 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each participant's name and type of intervention (placebo or zinc sulfate) are written on a piece of paper and enclosed in an envelope. The envelopes containing the names of the participants will be placed in one box, and the envelopes containing the type of intervention will be placed in the other box. An uninformed person first picks up an envelope from the first box and then from the second box and gives it to the study coordinator. The coordinator writes down the participant's name and the selected intervention type. The process continues until all boxes are emptied, Blinding description: This study uses a placebo similar to zinc tablets that have similar appearance properties. Patients are not aware of the type of substances they receive and are unaware of their intervention type. Also, health care providers and evaluators of the results of interventions do not know the patient groups and the type of medication received. 2-3 Chronic pelvic pain syndrome. Intervention 1: Intervention group: Patients in this group, in addition to routine medications, treated with zinc supplements (made by Abian Company, containing 41.4 mg of zinc sulfate) will take daily intake for 1 month. Before the interventions, after 2 weeks and 1 month, the amount of pain and chronic pelvic pain will be measured and compared by a questionnaire. Intervention 2: Control group: Patients in this group will receive placebo tablets daily for one month in addition to routine medications. Before the interventions, after two weeks and one month, the patients' pain and their chronic pelvic pain will be measured and compared by a questionnaire. Yes - There is a plan to make this available What will be shared: All data can be shared after people have requested. When: Six months after publishing the results. To whom: Academic researchers Conditions: Scientific uses Where to obtain: Website of the Research Committee of Hamedan University of Medical Sciences How to obtain: Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data. Comments:
public Behruz Karkhanei
Eram Blvd.
Hamadan Iran (Islamic Republic of) 6517953371 +98 81 3838 0706 bk13472000@yahoo.com Hamedan University of Medical Sciences scientific Maedeh Mohseni
Eram Blvd.
Hamadan Iran (Islamic Republic of) 8174673461 +98 81 3838 0706 mao_mohseni@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age between 18-65 years Diagnosis of chronic pelvic pain syndrome by a urologist Absence of underlying disease Free and informed written consent 18 years 65 years Both Failure to take medication regularly Drug intolerance Taking zinc supplements during the last 3 months Tendency to leave during the study R10.2 Pelvic and perineal pain Treatment - Drugs Placebo Intervention group: Patients in this group, in addition to routine medications, treated with zinc supplements (made by Abian Company, containing 41.4 mg of zinc sulfate) will take daily intake for 1 month. Before the interventions, after 2 weeks and 1 month, the amount of pain and chronic pelvic pain will be measured and compared by a questionnaire. Control group: Patients in this group will receive placebo tablets daily for one month in addition to routine medications. Before the interventions, after two weeks and one month, the patients' pain and their chronic pelvic pain will be measured and compared by a questionnaire. Pain. Timepoint: Before and after two weeks and one month after interventions. Method of measurement: Visual analog scale. Chronic pelvic pain. Timepoint: Before and after two weeks and one month after interventions. Method of measurement: Chronic Prostatitis Symptom Index (NIH-CPSI). Hamedan University of Medical Sciences Approved 2022-05-06 Ethics committee of Hamadan University of Medical Sciences Shahid Fahmideh St. Hamadan Hamadan Iran (Islamic Republic of)