gasteroesophageal reflux disease. Gastro-oesophageal reflux disease
Conditions
Interventions
Intervention 1: Intervention group is received omeprazole capsules and Myrtle fruit syrup. Omeprazole (Abidi®) will be prescribed 1 mg/kg/day in 2 divided Dose, 15 min before child feeding while Myrtl
Treatment - Drugs
Placebo
Intervention group is received omeprazole capsules and Myrtle fruit syrup. Omeprazole (Abidi®) will be prescribed 1 mg/kg/day in 2 divided Dose, 15 min before child feeding while Myrtle fruit syrup w
Control group is received omeprazole capsules and placebo syrup. Omeprazole (Abidi®) will be prescribed 1 mg/kg/day in 2 divided Dose, 15 min before child feeding while placebo syrup will be prescrib
Sponsors
Vice Chancellor for Research, Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
1 Years to 7 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam al-sadat Paknejad
faculty of traditional medicine of Tehran University of Medical Sciences
Outcome results
None listed