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IRCT20210308050634N1 IRCT 2021-06-12 Islamic Azad University Comparison of the effect of baclofen and proton pump inhibitors in patients with gastroesophageal reflux disease Comparison of the effectiveness of proton pump inhibitor (PPI) alone and with the method of adding baclofen to proton pump inhibitor (PPI) in the treatment of patients with gastroesophageal reflux disease (GERD) aged 7 to 12 years 2021-05-24 anticipated 60 Complete https://irct.ir/trial/56438 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: After fully explaining the process of studying to patients and obtaining informed consent from patients, patients enter one of the treatment groups selected by the physician. 3 gastroesophageal reflux disease. Intervention 1: Intervention group: Intervention group: An omeprazole group with a dose of 1 mg per kg body weight and baclofen 0.15 mg per kg body weight when patients are monitored. Received therapeutic intervention and were evaluated before the intervention and two weeks after the end of the intervention in terms of standardized indicators based on age. Intervention 2: Control group: In this study, omeprazole was administered to the control group at a dose of 1 mg per kg body weight and patients were monitored.The relevant reflux standard questionnaire is completed before starting treatment and two weeks after starting treatment.Patients received treatment for 2 weeks and were evaluated for standardized criteria based on age before the intervention and two weeks after the intervention. Yes - There is a plan to make this available What will be shared: The data obtained from the study will be published in the form of an article. When: 6 to 12 months To whom: Everyone in medicine Conditions: To people who study gastroesophageal reflux disease Where to obtain: Email to the person performing the project How to obtain: ایمیل به فرد مجری - تقاضا از معاونت پژوهشی دانشگاه- در صورت مثبت بودن ارایه اطلاعات به فرد متقاضی Comments:
public Dr. vajih Modarresi
Alem Square,Safaieh,Yazd
Yazd Iran (Islamic Republic of) 8915813135 +98 35 3725 1830 drmodarressi@gmail.com Islamic Azad University scientific Dr. vajih Modarresi
Alem Square , Safaieh,Yazd
Yazd Iran (Islamic Republic of) 8915813135 +98 35 3833 0756 drmodarressi@gmail.com Islamic Azad University Iran (Islamic Republic of) Children 7-12 years with gastroesophageal reflux disease 7 years 12 years Both Cases of specific diseases (cerebral palsy, treated with anticonvulsant drugs, patients with gastrointestinal ulcers and IBD) K21 Gastro-esophageal reflux disease Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: An omeprazole group with a dose of 1 mg per kg body weight and baclofen 0.15 mg per kg body weight when patients are monitored. Received therapeutic intervention and were evaluated before the intervention and two weeks after the end of the intervention in terms of standardized indicators based on age. Control group: In this study, omeprazole was administered to the control group at a dose of 1 mg per kg body weight and patients were monitored.The relevant reflux standard questionnaire is completed before starting treatment and two weeks after starting treatment.Patients received treatment for 2 weeks and were evaluated for standardized criteria based on age before the intervention and two weeks after the intervention. Voice violence or difficulty speaking. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire. Heartburn or chest pain or sourness. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire. Clear the throat. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire. Coughing after eating or lying down. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire. Night cough. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire. Shortness of breath or suffocation. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire. Feeling of a lump in the throat that is not relieved by eating. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire. Sputum in the throat. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire. Hard swallowing of liquids and solids. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire. Islamic Azad University Approved 2020-06-24 Ethics Committee of Azad University of Medical Sciences, Yazd Branch Alem Square,Safaieh,Yazd Yazd Yazd Iran (Islamic Republic of)