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Investigating the effectiveness of melatonin on gastrointestinal symptoms of functional abdominal pain

Investigating the efficacy of melatonin on gastrointestinal symptoms among pediatric patients with functional abdominal pain

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250805066773N1
Enrollment
44
Registered
2025-08-25
Start date
2025-09-23
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Gastrointestinal symptoms in children with functional abdominal pain. Other and unspecified abdominal pain

Interventions

Intervention 1: Intervention group: People who entered the study and were diagnosed with unspecified functional abdominal pain will receive Razak Company melatonin supplements for 4 weeks from the beg

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 18 Years

Inclusion criteria

Inclusion criteria: Age 3 to 18 years negative tissue transglutaminase antibodies and ruling out celiac disease Definitive diagnosis of functional abdominal pain based on the Rome IV criteria, which includes functional abdominal pain with other causes (FAP-NOS).

Exclusion criteria

Exclusion criteria: Incomplete information Immunocompromised patients Uncontrolled co-morbidities (e.g. type 1 diabetes, hypothyroidism) Taking medications that affect bowel movements (laxatives, probiotics, etc.)

Design outcomes

Primary

MeasureTime frame
Pain relief. Timepoint: Before the start of the intervention and at the end of the intervention after 4 weeks of treatment. Method of measurement: Wong-Baker FACES Pain Rating Scale.;Gastrointestinal symptoms (diarrhea, nausea and vomiting, constipation, etc.). Timepoint: Before the start of the intervention and at the end of the intervention after 4 weeks of treatment. Method of measurement: Reported clinical symptoms.

Secondary

MeasureTime frame
Severity of disease symptoms. Timepoint: Before the intervention and the end of the intervention after 4 weeks of treatment. Method of measurement: Clinical Global Impression-Severity.;Rate of improvement in symptoms. Timepoint: Before the intervention and the end of the intervention after 4 weeks of treatment. Method of measurement: Clinical Global Impression-Improvement.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElham Rahnemoun

Tehran University of Medical Sciences

mosafer2512@gmail.com+98 21 7301 3000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026