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Efficacy of Melatonin Treatment on Sleep Quality Improvement in Inflammatory Bowel Disease Patients With Clinical Remission
Sponsor: Mahidol University
Summary
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 patients in clinical remission.
Official title: Efficacy of Melatonin Treatment on Sleep Quality Improvement in Inflammatory Bowel Disease Patients With Clinical Remission: A Randomized Double-Blind Placebo-Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2025-04-01
Completion Date
2027-04-30
Last Updated
2026-08-04
Healthy Volunteers
No
Conditions
Interventions
Melatonin ("Circadin")
2 mg of prolonged release melatonin was prescribed at a dose of one tablet daily, taken one hour before the participant's usual bedtime.
Placebo
placebo were manufactured to be identical in appearance
Locations (1)
Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University 2 Wang Lang Rd
Bangkok Noi, Bangkok, Thailand