The effect of melatonin in the improvement of the symptoms in irritable bowel syndrome patients with sleep disturbance
Phase 1
- Conditions
- symptoms of irritable bowel syndromeIBSsymptomirritablebowelsyndromemelatonin
- Registration Number
- TCTR20210218002
- Lead Sponsor
- Ratchadapiseksompotch Research Fund
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
1. Patients age 18 years or more
2. The patients who have symptoms of irritable bowel syndrome at least 3 months before registry
3. The symptoms of IBS disturb activity daily life
4. Have sleep disturbance (Pittsburgh sleep quality index at least 5)
5. give the inform consent
Exclusion Criteria
1. Pregnancy or lactation
2. History surgery of gastrointestinal tract
3. History of neurological disorder
4. History of organic disease of gastrointestinal tract, liver disease, diabetes
5. shift worker
6. Taking sleeping pill within 2 weeks before registry
7. poor compliance
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Irritable bowel syndrome symptoms after end of the intervention IBS severity score system
- Secondary Outcome Measures
Name Time Method sleep quality after end of the intervention Pittsburgh sleep quality index , Epworth sleepiness scale, Actigraphy,quality of life after end of the intervention SF-36 (The short form health survey-36), HADS (Hospital Anxiety and Depression Scale),rectal sensation after end of the intervention Anorectal manometry and rectal sensory testing