The effect of myrtle fruit syrup on children reflux disease

Phase 3

Conditions: gasteroesophageal reflux disease.
Gastro-oesophageal reflux disease

Registration Number: IRCT2016061828521N1

Lead Sponsor: Vice Chancellor for Research, Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 50

Inclusion Criteria

1.1 to 7 years old children attended to Bahrami’s children hospital gastro-enterology clinic;
2.Diagnosis of GERD on the basis of GSQ-YC questionnaire and pediatric gastroenterologist;
3.Absence of serious gastrointestinal diseases such as esophagitis, achalasia, gastrointestinal ulcers, IBD (Inflamatory Bowel disease),….;
4.Absence of GERD complications such as: esophagitis and ulcers;
5.Absence of every serious condition such as severe asthma;
6.Absence of gastrointestinal anomalies;
7.Absence of cognitive or mental disorders;
8.Absence of history of PPIs (Proton Pomp Inhibitors) or H2 Blockers consumption in 1 week before;
9.Absence of severe constipation;

Exclusion criteria:
1.Patient’s lack of tendency to continue the trial;
2.Significant conditions which can be considered as drug side effects;
3.Exacerbation of GERD symptoms throughout the trial;
4.Allergy history to myrtle;
5.Significant history of allergy to herbal compounds or food allergy;

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vomiting / Regurgitation. Timepoint: 0th, 2nd, 3rd month after treatment start. Method of measurement: GSQ-YC questionnaire.;Choking when eating. Timepoint: 0th, 2nd, 3rd month after treatment start. Method of measurement: GSQ-YC questionnaire.;Abdominal pain. Timepoint: 0th, 2nd, 3rd month after treatment start. Method of measurement: GSQ-YC questionnaire.;Burping / belching. Timepoint: 0th, 2nd, 3rd month after treatment start. Method of measurement: GSQ-YC questionnaire.;Difficulty swallowing. Timepoint: 0th, 2nd, 3rd month after treatment start. Method of measurement: GSQ-YC questionnaire.;Refusal to eat. Timepoint: 0th, 2nd, 3rd month after treatment start. Method of measurement: GSQ-YC questionnaire.

Secondary Outcome Measures

Name	Time	Method
Side effect. Timepoint: any time throughout the survey. Method of measurement: babysitter report.;Anti-acid use frequency. Timepoint: 0th, 2nd, 3rd month after treatment start. Method of measurement: babysitter report.;Drug's form satisfaction. Timepoint: 7th day after treatment start. Method of measurement: babysitter report.;Maximum efficacy. Timepoint: 7th day after treatment start. Method of measurement: babysitter report.