The Therapeutic Effect of Melatonin in Pediatric Patients With Functional Dyspepsia
Abstract
There are two specific aims in this study.
Specific Aim 1: Determine if melatonin results in a higher grade of clinical response than does placebo in children with functional dyspepsia (FD).
Hypothesis: treatment of FD with melatonin will result in a higher grade of clinical response than will treatment with a placebo.
Specific Aim 2: Evaluate the relationship between changes in sleep and improvement in pain in pediatric patients with functional dyspepsia receiving melatonin.
Hypothesis: There will be no association between improvement in pain and improvement in sleep in children with functional dyspepsia receiving melatonin.
Conditions: Dyspepsia.
Primary outcome: Grade of clinical response to Melatonin in children with functional dyspepsia.
Enrollment: 14 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 14 participants or records.
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