NCT07737665 Efficacy of Melatonin Treatment on Sleep Quality Improvement in Inflammatory Bowel Disease Patients With Clinical Remission
| NCT ID | NCT07737665 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Mahidol University |
| Condition | IBD (Inflammatory Bowel Disease) |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 90 participants in total. It began in 2025-04-01 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Julajak Limsrivilai, MD
PRINCIPAL INVESTIGATOR
Faculty of Medicine Siriraj Hospital, Mahisol University
Frequently Asked Questions
Who can join the NCT07737665 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying IBD (Inflammatory Bowel Disease). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07737665 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07737665 currently recruiting?
Yes, NCT07737665 is actively recruiting participants. Contact the research team at alimsrivilai@gmail.com for enrollment information.
Where is the NCT07737665 trial being conducted?
This trial is being conducted at Bangkok Noi, Thailand.
Who is sponsoring the NCT07737665 clinical trial?
NCT07737665 is sponsored by Mahidol University. The principal investigator is Julajak Limsrivilai, MD at Faculty of Medicine Siriraj Hospital, Mahisol University. The trial plans to enroll 90 participants.