Pediatric gastro-oesophageal reflux disease. Gastro-oesophageal reflux disease without oesophagitis
Conditions
Interventions
Intervention 1: Omeprazole syrup, 1.5 mg\kg\day, oral, twice a day, 4 weeks. Intervention 2: Cydonia oblonga syrup, 1.5 g\kg\day, oral, twice a day, 4 weeks.
Treatment - Drugs
Omeprazole syrup, 1.5 mg\kg\day, oral, twice a day, 4 weeks
Cydonia oblonga syrup, 1.5 g\kg\day, oral, twice a day, 4 weeks
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
1 Months to 18 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: children more than one month and less than 18 years old; signed an informed consent form by parents; Vomiting immediately after eating; restlessness for one to three hours after feeding; respiratory distress after feeding; the lack of weight gain; refusing to eat; endoscopically proven gasteroeshophageal reflux disease. Exclusion criteria: Children younger than 1 month and older than 18 years old; those who need to use other oral or intravenous drugs; unwillingness to continue to participate in the study; sensitivity to study drugs; patients with other gasteroeshophageal disorders such as esophagitis and peptic ulcer; patients with active renal, liver and neurological diseases; mental retardation; pregnancy; lactation and disability of parents/guardian to cooperate in filling the forms (cognitive or language disorder).
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vomiting/regurgitation episodes. Timepoint: Weekly. Method of measurement: Age specific gastroesophageal reflux disease questionnaire.;Severity of Vomiting/regurgitation. Timepoint: Weekly. Method of measurement: Age specific gastroesophageal reflux disease questionnaire.;Refusal of feed episodes. Timepoint: Weekly. Method of measurement: Age specific gastroesophageal reflux disease questionnaire.;Severity of feed refusal. Timepoint: Weekly. Method of measurement: Age specific gastroesophageal reflux disease questionnaire.;Irritability/Fussiness episodes. Timepoint: Weekly. Method of measurement: Age specific gastroesophageal reflux disease questionnaire.;Severity of Irritability/Fussiness. Timepoint: Weekly. Method of measurement: Age specific gastroesophageal reflux disease questionnaire.;Hiccup/Belching episodes. Timepoint: Weekly. Method of measurement: Age specific gastroesophageal reflux disease questionnaire.;Severity of hiccup/belching. Timepoint: Weekly. Method of measurement: Age specific gastroesophageal reflux disease questionnaire.;Choking when eating episodes. Timepoint: Weekly. Method of measurement: Age specific gastroesophageal reflux disease questionnaire.;Severity of Choking when eating. Timepoint: Weekly. Method of measurement: Age specific gastroesophageal reflux disease questionnaire.;Arching back episodes. Timepoint: Weekly. Method of measurement: Age specific gastroesophageal reflux disease questionnaire.;Severity of arching back. Timepoint: Weekly. Method of measurement: Age specific gastroesophageal reflux disease questionnaire.;Abdominal pain episodes. Timepoint: Weekly. Method of measurement: Age specific gastroesophageal reflux disease questionnaire.;Severity of abdominal pain. Timepoint: Weekly. Method of measurement: Age specific gastroesophageal reflux disease questionnaire.;Nausea episodes. Timepoint: Weekly. Method of measurement: Age specific gastroesophageal reflux disease questionnaire.;Severity of nausea. Timepoint: Weekly. Meth | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactZohalinezhad
Shiraz University of Medical Sciences
Outcome results
None listed