Determination of the melatonin effect on gastrointestinal symptoms and quality of life in patients with irritable bowel syndrome with and without sleep disorders

Comparison of the melatonin effect on gastrointestinal symptoms and quality of life in irritable bowel syndrome patients with and without sleep disorders

Double blind randomised _ paralled clinical trial which participants randomly allocated to control (n=68) and melatonin supplementation groups(n=68)

In this study, patients referred to Imam Reza Hospital, after the definitive diagnosis of irritable bowel syndrome, using the ROME 4 diagnosis index, enter the study if they complete the informed consent form. According to the PSQI sleep questionnaire, patients were divided into two groups with and without sleep disorders. Each group are randomly divided into control and paralled groups, and the paralled group will receive 2 melatonin 3 mg tablets and the control group received two placebo.

Inclusion criteria: Patients diagnosed with irritable bowel syndrome based on ROME 4 diagnostic index. According to the PSQI sleep questionnaire, they are with and without sleep disorders. Exclusion criteria: depression, history of bowel surgery, dietary supplements and herbal remedies

Paralled group will receive 2 melatonin 3 mg tablets every 12 hours.The control group also will receive two placebo pills every 12 hours.

In this study, the effects of melatonin tablets on the severity of abdominal pain, bloating intensity, stool form, quality of life (Based on a valid quality of life questionnaire in patients with irritable bowel syndrome), sleep quality (Based on PSQI sleep quality questionnaire) in patients with irritable bowel syndrome will be evaluated in comparison with the control group.

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.

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.