Efficacy of Melatonin Treatment on Sleep Quality Improvement in Inflammatory Bowel Disease Patients With Clinical Remission
Phase 4 · Testing Melatonin ("Circadin") · 1 site · Mahidol University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Melatonin ("Circadin") (a drug) as a possible treatment. Condition(s) listed: IBD (Inflammatory Bowel Disease).
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 1 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 90 participants are expected to take part.
- Start date: 2025-04-01.
- Main results expected around 2027-04-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Thailand.
Main thing being measured
- PSQI (Pittsburgh Sleep Quality Index) score at 12th week of study (12 weeks)
In the researchers’ words
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 is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | IBD (Inflammatory Bowel Disease) |
| Lead sponsor | Mahidol University |
| Enrollment | 90 (estimated) |
| Start date | 2025-04-01 |
| Primary completion (est.) | 2027-04-01 |
| First posted | 2026-07-30 |
| Last updated | 2026-08-04 |
| 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 |
| ClinicalTrials.gov ID | NCT07737665 |
Interventions
- Melatonin ("Circadin") (Drug)
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 (Drug)
placebo were manufactured to be identical in appearance
Full eligibility criteria (from the record)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University 2 Wang Lang Rd | Bangkok Noi, Bangkok | Thailand | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.