comparison of the melatonin effect in irritable bowel syndrome patients

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220104053626N2

Enrollment

136

Registered

2022-02-13

Start date

2022-01-20

Completion date

Unknown

Last updated

2022-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome. Irritable bowel syndrome

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Previous history of diagnosed gastrointestinal diseases including IBD Intestinal surgery Depression Receive herbal medicines

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasood Dinevari

Tabriz University of Medical Sciences

masood.dinevari@gmail.com+98 41 3334 2500

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 11, 2026