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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMahidol University

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 patients in clinical remission.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Melatonin ("Circadin")
  • Placebo

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators