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)
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Main outcome variables
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.
Reason for update
IRCT registration information
IRCT registration number:IRCT20220104053626N2
Registration date:2022-02-13, 1400/11/24
Last update:2022-02-13, 1400/11/24
Name of organization / entity
Iran (Islamic Republic of)
+98 41 3334 7054
Expected recruitment start date
Expected recruitment end date
Actual recruitment start date
Actual recruitment end date
Trial completion date
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 in irritable bowel syndrome patients
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
Previous history of diagnosed gastrointestinal diseases including IBD
Receive herbal medicines
No age limit
Groups that have been masked
Target sample size:
Randomization (investigator's opinion)
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 (investigator's opinion)
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.
Other design features
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Tabriz University of Medical Sciences, Daneshgah St, Golgasht St.
Ethics committee reference number
Health conditions studied
Description of health condition studied
Irritable Bowel Syndrome
ICD-10 code description
Irritable bowel syndrome
Abdominal pain severity based on a questionnaire on a percentage scale,From zero with an increase of 25 units