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The effect of melatonin in the improvement of the symptoms in irritable bowel syndrome patients with sleep disturbance

The effect of melatonin in the improvement of the symptoms in irritable bowel syndrome patients with sleep disturbance

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210218002
Enrollment
28
Registered
2021-02-18
Start date
2021-04-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

symptoms of irritable bowel syndrome IBS symptom irritable bowel syndrome melatonin

Interventions

Melatonin SR (2 mg) 1 tab before bedtime,Placebo taking 1 tab before bedtime
Placebo Comparator Drug,No Intervention No treatment

Sponsors

Ratchadapiseksompotch Research Fund
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients age 18 years or more 2. The patients who have symptoms of irritable bowel syndrome at least 3 months before registry 3. The symptoms of IBS disturb activity daily life 4. Have sleep disturbance (Pittsburgh sleep quality index at least 5) 5. give the inform consent

Exclusion criteria

Exclusion criteria: 1. Pregnancy or lactation 2. History surgery of gastrointestinal tract 3. History of neurological disorder 4. History of organic disease of gastrointestinal tract, liver disease, diabetes 5. shift worker 6. Taking sleeping pill within 2 weeks before registry 7. poor compliance

Design outcomes

Primary

MeasureTime frame
Irritable bowel syndrome symptoms after end of the intervention IBS severity score system

Secondary

MeasureTime frame
sleep quality after end of the intervention Pittsburgh sleep quality index , Epworth sleepiness scale, Actigraphy,quality of life after end of the intervention SF-36 (The short form health survey-36), HADS (Hospital Anxiety and Depression Scale),rectal sensation after end of the intervention Anorectal manometry and rectal sensory testing

Countries

Thailand

Contacts

Public ContactNatsida Rathanaviriyachai

Faculty of medicine, Chulalongkorn university

natsida_99@docchula.com0863715996

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026