IBD study: Melatonin
Official title Efficacy of Melatonin Treatment on Sleep Quality Improvement in Inflammatory Bowel Disease Patients With Clinical Remission
ClinicalTrials.gov ID: NCT07737665
What this study is testing
What is Melatonin ("Circadin")?
Melatonin ("Circadin") is an investigational medicine, taken by mouth once daily, being studied as a potential treatment for ibd (inflammatory bowel disease).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 likely can't join 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
The study team makes the final eligibility decision.
Where it is enrolling
- Bangkok Noi, Bangkok, Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bangkok Noi, Bangkok, Thailand. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.