Efficacy of Melatonin Treatment on Sleep Quality Improvement in Inflammatory Bowel Disease Patients With Clinical Remission

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: IBD (Inflammatory Bowel Disease)

In brief

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.

Key facts

Study ID

NCT07737665

Run by

Mahidol University

People needed

90

Starts

2025-04-01

Expected to finish

2027-04-30

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Current alcohol or substance abuse
• High risk for OSA (STOP-BANG score > 5)
• Psychiatric problem: PHQ-9 score > 20 or GAD-7 score > 20
• Hypnotic drug use and unable to hold for 1week before trial
• Shift worker

Where it is running

• Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University 2 Wang Lang Rd — Bangkok Noi, Bangkok, Thailand (enrolling)

Full record on ClinicalTrials.gov

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