Efficacy of Melatonin Treatment on Sleep Quality Improvement in Inflammatory Bowel Disease Patients With Clinical Remission
Recruiting
Phase 4
Interventional Study
IBD (Inflammatory Bowel Disease)
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 90 (estimated)
- Sponsor
- Mahidol University · Other
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About This Trial
Sleep disturbances are common in patients with inflammatory bowel disease (IBD) and are associated with increased disease activity and reduced quality of life. Melatonin, a hormone regulating circadian rhythms, has shown potential anti-inflammatory and sleep-promoting effects in preliminary studies. This study aimed to evaluate the efficacy of melatonin supplementation on sleep quality in IBD pati…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* IBD patients with clinical remission Crohn's disease: HBI \< 5 Ulcerative colitis: Partial Mayo score 0-1 w/o bloody stool
* Age \> 18 years
* PSQI score \> 5
* No medical adjustment for 2 months and use corticosteroids not more than Prednisolone equivalent 5 mg/day
Exclusion…
Contacts