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IRCT20191027045256N1 IRCT 2020-03-09 Kashan University of Medical Sciences effect of omeprazole and es-omeprazole in reflux disease Comparison of the effect of treatment with omeprazole and es-omeprazole in reflux disease (GERD) infants Lesser than one year old 2019-10-07 anticipated 80 Complete https://irct.ir/trial/43320 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Patients will be randomly assigned to receive an oral dose of these two drugs at random for four weeks, in which participants, parents, caregivers, researchers, and pharmacists will be blinded to treatment. 3 GERD. Intervention 1: Intervention group 1: Esomeprazole Abidi company,. Intervention 2: Intervention group 1: eprazole Abidi company. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Mohamadali Sabahi
Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan
Kashan Iran (Islamic Republic of) 87159-81151 +98 31 5557 8010 alisabahi1369@gmail.com Kashan University of Medical Sciences scientific Seyed Ramin Madani
Kashan University of Medical Sciences, Qotbe Ravandi Blvd, Kashan
Kashan Iran (Islamic Republic of) 87159-81151 +98 31 5557 8010 drraminmadani@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Infants 1 to 11 months of age with clinical diagnosis of reflux based on symptoms or endoscopic evidence 1 month 11 months Both Using a PPI in the last 7 days Treatment for reflux symptoms, including histamine 2 receptor antagonists, procinetics, and bismuth-containing antacids within 24 hours before intervention Patients with active gastrointestinal bleeding, apnea, allergic gastroenteritis, eosinophilic gastroenteritis, bleeding disorders, pyloric stenosis, active seizure disorder, acute pancreatitis or meningitis K21.9 Gastro-esophageal reflux disease without esophagitis Treatment - Drugs Treatment - Drugs Intervention group 1: Esomeprazole Abidi company, Intervention group 1: eprazole Abidi company Effect of Omeprazole and S-Omeprazole in Children. Timepoint: Symptoms evaluated included vomiting, contractility, irritability, hyper-esophageal and respiratory disorders (eg cough, wheezing / steroids) and nutritional problems (eg, dizziness / choking). 1 hour will be defined. Vomiting / regurgitation volume will be classified as small (5-15 ml), medium (15-30 ml), large (more than 30 ml) at any time of 4 weeks. Method of measurement: Recovery involves reducing the severity of symptoms to more than half of the initial symptom score (before the intervention). Kashan University of Medical Sciences Approved 2019-10-06 Ethics committee of Kashan University of Medical Sciences Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan Kashan Isfehan Iran (Islamic Republic of)