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 were manufactured to be identical in appearance