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IRCT2016061828521N1 IRCT 2016-09-04 Vice Chancellor for Research, Tehran University of Medical Sciences The effect of myrtle fruit syrup on children reflux disease Double blind randomized clinical trial in treatment of gastroesophageal reflux disease in children with Myrtus Communis L. (Myrtle) fruit. 2016-08-05 anticipated 50 Complete https://irct.ir/trial/23125 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 3 gasteroesophageal reflux disease. 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.
public Maryam al-sadat Paknejad
Khark Traditional Iranian Medicine Clinic, Khark st, Enghelab st, Tehran, Iran
Tehran Iran (Islamic Republic of) +98 26 3446 2488 m-paknejad@razi.tums.ac.ir; neurointmed@gmail.com; neurointmed@yahoo.com faculty of traditional medicine of Tehran University of Medical Sciences scientific Dr. Mehrdad Karimi
Ahmadieh Iranian Traditional Medicine Clinic, Sarparast st, Taleghani st, Tehran, Iran.
Tehran Iran (Islamic Republic of) +98 21 6675 4166 mehrdadkarimi@yahoo.com faculty of traditional medicine of Tehran University of Medical Sciences Iran (Islamic Republic of) 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; 1 year 7 years Both K21 Gastro-oesophageal reflux disease 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 will be prescribed 0.21 mg/kg/day in 3 divided Dose, after child feeding. Treatment course will be 2 months. 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. 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. 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. Vice Chancellor for Research, Tehran University of Medical Sciences Approved 2016-06-18 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Poursina St, 16 Azar St, Tehran, Iran. Tehran Iran (Islamic Republic of)