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IRCT20170501033750N2 IRCT 2018-04-20 Babol University of Medical Sciences The effect of Quince syrup in pediatric gastroesophageal reflux aged 12 to 48 months Comparison of the effect of ranitidine syrup with Quince syrup in pediatric gastroesophageal reflux aged 12 to 48 months 2017-06-10 anticipated 80 Complete https://irct.ir/trial/25955 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of randomization in this study is quadruple blocking method and the randomization unit is individual and tool is statistical software. The sequencing will be done by quadruple blocking. Concealing done by using similar form and size bottle for both groups, and neither the interventions nor the volunteers knows how to allocate the intervention, Blinding description: In this study, patients are completely unaware of which drugs they received. Also, the investigator is completely unaware that the two groups received which drug. 3 Gastro-oesophageal reflux. Intervention 1: The intervention group are given quince syrup twice daily with ranitidine syrup for 4 weeks. Intervention 2: The placebo control group are given sugar syrup twice daily with ranitidine syrup for 4 weeks. Yes - There is a plan to make this available What will be shared: On the basis of the reliable questionnaire When: After article publication To whom: All people Conditions: Published article according to Ph.D. thesis Where to obtain: Babol university of medical sciences،timbabol@yahoo.com، 00981132194730 How to obtain: Library of Babol university of medical science Comments:
public Maryam Naeimi
Babol University of Medical Sciences
Babol Iran (Islamic Republic of) 4774547176 +98 11 3219 2832 naeimima@yahoo.com Babol University of Medical Sciences scientific Narjes Gorji
Babol University of Medical Sciences
Babol Iran (Islamic Republic of) 9197613111 +98 11 3219 4730 n.gorji@mubabol.ac.ir دانشگاه علوم پزشکی بابل Iran (Islamic Republic of) Patients in the age group of 12 to 48 months. People with at least 2 times a week with common symptoms of reflux disease (heartburn, regurgitation, vomiting, epigastric pain and appropriate weight loss for at least a month Those who are newly diagnosed or who have been suffering from reflux, have not taken any medications for at least one month and will want to start their treatment again 1 year 4 years Both Patients with severe reflux disease (severe onset: symptoms of severe esophagitis, vomiting, life-threatening symptoms such as apnea, pneumonia, esophageal stricture and systemic diseases) due to the need for treatments Another intervention, including surgery or other medications, is withdrawn from the project because of ethical considerations (non-deprivation of the patient and non-risk for the volunteers) Children with a disease (neurological, cardiac, pulmonary, liver and kidney) or mental retardation People who have used other herbal remedies during this period People who need to use chemical drugs during the plan due to the specific disease People with a history of allergy to herbal medicines K21 Gastro-esophageal reflux disease Treatment - Drugs Placebo The intervention group are given quince syrup twice daily with ranitidine syrup for 4 weeks. The placebo control group are given sugar syrup twice daily with ranitidine syrup for 4 weeks. Severity of nausea. Timepoint: A week before treatment, the second, fourth and sixth weeks after treatment. Method of measurement: GSQ-YC standard questionnaire. Numbers of vomiting. Timepoint: A week before treatment, the second, fourth and sixth weeks of treatment. Method of measurement: GSQ-YC standard questionnaire. Severity of hiccups. Timepoint: The beginning of the week, the second week, the fourth, the sixth. Method of measurement: GSQ-YC standard questionnaire. Severity of abdominal pain. Timepoint: The beginning of the week, the second week, the fourth, the sixth. Method of measurement: GSQ-YC standard questionnaire. Freqency of abdominal pain. Timepoint: The beginning of the week, the second week, the fourth, the sixth. Method of measurement: GSQ-YC standard questionnaire. Severity of regurgitation. Timepoint: The beginning of the week, the second week, the fourth, the sixth. Method of measurement: GSQ-YC standard questionnaire. Frequency of hiccups. Timepoint: The beginning of the week, the second week, the fourth, the sixth. Method of measurement: GSQ-YC standard questionnaire. Refuse to eat. Timepoint: The last week of treatment, the second week of the fourth and sixth treatment. Method of measurement: GSQ-YC standard questionnaire. Inappropriate weighing. Timepoint: Before starting treatment and then finishing treatment for the sixth week. Method of measurement: Baby growth curve. Swallowing disorder. Timepoint: Before starting treatment and during treatment until the 6th week. Method of measurement: GSQ-YC standard questionnaire. Side effects. Timepoint: Any time during treatment. Method of measurement: Baby Nurse Report. Repeated use of anti-acid. Timepoint: First and second months of treatment. Method of measurement: Baby Nurse Report. Babol University of Medical Sciences Approved 2017-03-15 Babol University of Medical Sciences Ganj Afroz Street.babol Babo Mazandaran Iran (Islamic Republic of)