The effect of myrtle fruit syrup on children reflux disease

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2016
INTERVENTION: 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 prescribed 0.21 mg/kg/day in 3 divided Dose, after child feeding. Treatment course will be 2 months. 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 Myrtle fruit syrup will be prescribed 0.21 mg/kg/day in 3 divided Dose, after child feeding. Treatment course will be 2 months. Intervention 2: 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 prescribed 0.21 mg/kg/day in 3 divided Dose, after child feeding. Treatment course will be 2 months. 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 will be prescribed 0.21 mg/kg/day in 3 divided Dose, after child feeding. Treatment course will be 2 months. Placebo Treatment ‐ Drugs CONDITION: gasteroesophageal reflux disease. ; Gastro‐oesophageal reflux disease Gastro‐oesophageal reflux disease PRIMARY OUTCOME: 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. Choking when eating. 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. Vomiting / Regurgitation. Timepoint: 0th, 2nd, 3rd month after treatment start. Method of measurement: GSQ‐YC questionnaire. SECONDARY OUTCOME: 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. Side effect. Timepoint: any time throughout the survey. Method of measurement: babysitter report. 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.
Epistemonikos ID: b44ddc88ce2f77b75bac335dc4b619ef1327054f
First added on: Mar 23, 2022