The effect of melatonin treatment in patients with Irritable Bowel Syndrome
Phase 2
- Conditions
- Irritabale Bowel Syndrome.Irritable bowel syndrome with diarrhoea, Irritable bowel syndrome without diarrhoeaK58.9, k58
- Registration Number
- IRCT2017012532186N1
- Lead Sponsor
- Vice chancellor for research, Arak University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 64
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
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.