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IRCT20220104053626N2 IRCT 2022-02-13 Tabriz University of Medical Sciences comparison of the melatonin effect in irritable bowel syndrome patients IBS Determination of the melatonin effect on gastrointestinal symptoms and quality of life in patients with irritable bowel syndrome with and without sleep disorders 2022-01-20 anticipated 136 Complete https://irct.ir/trial/61174 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Among the patients who volunteered to participate in the study, 136 people will be selected by simple random sampling. Randomization method: block Randomization unit: individual Random layers: In each block, people will be matched based on age and gender. Random allocation tool: Random allocation software How to build a random sequence: Using Random allocation software Concealment: A random sequence created in a safe place and performed by an independent person not involved in the trial during the study. Random allocation of hidden individuals, patients and researchers will not be aware of it, Blinding description: This study is a double-blind study in which the researcher of this study and the patients participating in the study will be unaware of the type of supplement received. The supplements will be provided to patients by another person who has no role in completing the questionnaire. They will also be informed of the existence of two types of supplements (melatonin and placebo) when obtaining consent, but will be unaware of which study groups they will be in. Placebo tablets are similar in appearance, color, and size to melatonin tablets. 2-3 Irritable Bowel Syndrome. Intervention 1: Intervention group: Melatonin. Patients in the intervention group who will take two melatonin 3 mg tablets daily (manufactured by Zahravi Pharmaceutical Company) for two months during the study. Intervention 2: Control group: Control group: placebo. Patients in the placebo group who will take two placebo tablets daily (manufactured by Zahravi Pharmaceutical Company) during two months of study. 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 There is no more information.
public Masood Dinevari
Emam reza hospital, Gogash st, Tabriz
Tabriz Iran (Islamic Republic of) 5165665931 +98 41 3334 2500 masood.dinevari@gmail.com Tabriz University of Medical Sciences scientific Masood dinevari
Emamreza hospital, Golgasht st, Tabriz
Tabriz Iran (Islamic Republic of) 5165665931 +98 41 3334 2669 masood.dinevari@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) being satisfied to participate in the study Patients with definitive diagnosis of IBS based on ROME 4 questionnaire, with sleep disorders diagnosed based on PSQI questionnaire. Patients with definitive diagnosis of IBS based on ROME 4 questionnaire, without sleep disorders no limit no limit Both Previous history of diagnosed gastrointestinal diseases including IBD Intestinal surgery Depression Receive herbal medicines K58 Irritable bowel syndrome Treatment - Other Placebo Intervention group: Melatonin. Patients in the intervention group who will take two melatonin 3 mg tablets daily (manufactured by Zahravi Pharmaceutical Company) for two months during the study. Control group: Control group: placebo. Patients in the placebo group who will take two placebo tablets daily (manufactured by Zahravi Pharmaceutical Company) during two months of study. Abdominal pain severity based on a questionnaire on a percentage scale,From zero with an increase of 25 units. Timepoint: Before and after the intervention. Method of measurement: Irritable Bowel Syndrome Symptoms Severity Questionnaire. Quality of life based on the quality of life questionnaire for patients with irritable bowel syndrome. Timepoint: Before and after the intervention. Method of measurement: the quality of life questionnaire for patients with irritable bowel syndrome. Intensity of bloating based on a questionnaire as a percentage scale,From zero with an increase of 25 units. Timepoint: Before and after the intervention. Method of measurement: Irritable Bowel Syndrome Symptoms Severity Questionnaire. Stool form. Timepoint: Before and after the intervention. Method of measurement: Irritable Bowel Syndrome Symptoms Severity Questionnaire. Tabriz University of Medical Sciences Approved 2021-08-01 Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Daneshgah St, Golgasht St. Tabriz East Azarbaijan Iran (Islamic Republic of)