Efficacy of Melatonin Treatment on Sleep Quality Improvement in Inflammatory Bowel Disease Patients With Clinical Remission: A Randomized Double-Blind Placebo-Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Thailand
Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University 2 Wang Lang Rd
RECRUITING
Bangkok Noi
Contact Information
Primary
Julajak Limsrivilai, MD
alimsrivilai@gmail.com
+66814968895
Backup
Ekawat Manomaiwong, MD
e_manomaiwong@hotmail.com
+66876818221
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 90
Treatments
Experimental: Melatonin
Participants were randomized into two groups to receive either 2 mg of prolonged release melatonin or placebo, which were manufactured to be identical in appearance. The study medication was prescribed at a dose of one tablet daily, taken one hour before the participant's usual bedtime. Participants were scheduled for follow-up at 6 and 12 weeks after initiation of the study medication, either at the IBD clinic or via telephone contact. At the 6-week follow-up, sleep quality was assessed using PSQI. If the PSQI score decreased from baseline, participants continued the study medication at the same dose until the end of the study. If the PSQI score remained unchanged or increased, the dose of the study medication was escalated to two tablets per day and continued at that dose until study completion.
Placebo_comparator: Placebo
placebo were manufactured to be identical in appearance
Related Therapeutic Areas
Sponsors
Leads: Mahidol University