The effect of melatonin treatment in patients with Irritable Bowel Syndrome

The effect of melatonin treatment in patients with Irritable Bowel Syndrome (IBS)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017012532186N1

Enrollment

Registered

2017-09-24

Start date

2017-02-19

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Irritabale Bowel Syndrome. Irritable bowel syndrome with diarrhoea, Irritable bowel syndrome without diarrhoea

Interventions

Intervention 1: In intervention group, melatonin would be given to patients in the form of 3 milligram tablets made by Nature Med for 8 weeks. Intervention 2: In control group, placebo would be given

Treatment - Drugs

Placebo

In intervention group, melatonin would be given to patients in the form of 3 milligram tablets made by Nature Med for 8 weeks.

In control group, placebo would be given to patients in the form of tablets similar to melatonin tablets for 8 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: Irritable Bowel Syndrome (IBS) based on Rome III criteria; Lack of comorbidity including anemia, blood in the stool, significant weight loss, nocturnal diarrhea, Inflammatory Bowel Disease (IBD); previous abdominal surgery; diabetes; thyroid disorders; do not use antibiotic in the last month; do not take drug for IBS treating in the last month. Exclusion criteria: lack of patient collaboration; drug addiction; any risk of heart disease; neurological and psychological disorder; gastrointestinal and liver disease; pregnancy; any kind of malignancy

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
The effect of melatonin on the abdominal pain in patients with irritable bowel syndrome. Timepoint: Before and 8 weeks after receiving a daily dose of 3 mg melatonin. Method of measurement: questionnare.;The effect of melatonin on the abdominal bloating in patients with irritable bowel syndrome. Timepoint: Before and 8 weeks after receiving a daily dose of 3 mg melatonin. Method of measurement: questionnare.;The effect of melatonin on the number of bowel movements and stool constipation in patients with irritable bowel syndrome. Timepoint: Before and 8 weeks after receiving a daily dose of 3 mg melatonin. Method of measurement: questionnare.	—

Measure

Time frame

The effect of melatonin on the abdominal pain in patients with irritable bowel syndrome. Timepoint: Before and 8 weeks after receiving a daily dose of 3 mg melatonin. Method of measurement: questionnare.;The effect of melatonin on the abdominal bloating in patients with irritable bowel syndrome. Timepoint: Before and 8 weeks after receiving a daily dose of 3 mg melatonin. Method of measurement: questionnare.;The effect of melatonin on the number of bowel movements and stool constipation in patients with irritable bowel syndrome. Timepoint: Before and 8 weeks after receiving a daily dose of 3 mg melatonin. Method of measurement: questionnare.

—

Secondary

Measure	Time frame
The effect of melatonin on the quality of life in patients with irritable bowel syndrome. Timepoint: Before and 8 weeks after taking 3 mg of melatonin tablets. Method of measurement: questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHossein Rashvand

Arak University Of Medical Sciences

h.rashvand@arakmu.ac.ir; horash64@yahoo.com+98 863417360110

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026