Primary outcomes: Can melatonin reduce symptoms in patients with irritable bowel syndrome better than placebo, as assessed by at least a 30% reduction in the average score of the most severe pain within 24 hours over 7 days, together with improved bowel movements according to FDA criteria? Secondary outcomes: Can melatonin improve the quality of life in patients with irritable bowel syndrome, as assessed by changes in the SF-36 (The Short Form Health Survey-36) and HADS (Hospital Anxiety and Dep
Conditions
Interventions
The medication used in this study is prolonged release melatonin (Circadin PR), 2 mg, taken 1 to 2 hours before bedtime for 28 days
,The placebo used in this study was manufactured by the Pharmaceutic
Active Comparator Drug,Placebo Comparator Drug
Sponsors
Department of Gastroenterology and Hepatology, Faculty of Medicine, Chulalongkorn University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients with irritable bowel syndrome, aged between 18 and 65 years, diagnosed according to the Rome III criteria, with an IBS Severity Scoring System (IBS-SSS) score greater than 175
Exclusion criteria
Exclusion criteria: History of gastrointestinal surgery or neurological disorders or liver diseases or other comorbidities such as diabetes mellitus, Patients who are shift workers, Patients at risk of obstructive sleep apnea, assessed by the STOP-BANG questionnaire with a score greater than 5
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of IBS symptom 1 month IBS-SSS, FDA criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of sleep quality 1 month Pittsburgh Sleep Quality Index , actigraphy ,changes in rectal sensory threshold 1 month Barostat,Improvement of quality of life 1 month SF-36 (The Short Form Health Survey-36), HADS (Hospital Anxiety and Depression Scale) scores | — |
Countries
Thailand
Contacts
Public ContactChanaporn Tochaeng
Chulalongkorn University
Outcome results
None listed