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IRCT2015102316844N2 IRCT 2016-02-27 Vice Chancellor for Research of Isfahan University of Medical Sciences Which one is more effective in cyclic vomiting syndrome treatment? Topitamate or Amitriptyline ? Comparison the effect of Topiramate and Amitriptyline Prophylactic therapy on cyclic vomiting syndrome in Pediatrics 2016-02-14 anticipated 60 Complete https://irct.ir/trial/15636 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization is performed using table of random numbers. 2-3 Cyclical vomiting syndrome. Intervention 1: Intervention group: In one group we will start topiramate for patients with the dosage of 1-2 mg/kg daily. Patients won't be aware of their drugs. The medication will be used for at list three months during the study. The medication is produced by Pars Daru company in Iran. Intervention 2: Control group: In the other group we will start Amitriptyline for patients with the dosage of 1 mg/kg daily. The medication will be used for at list three months during the study. The medication is produced by Pars Daru company in Iran.
public Zahra Bagherian
Hezar Jarib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3627 7831 shervin.badihian@gmail.com Isfahan University of Medical Sciences, Child Growth and Development Research Center scientific Omid Yaghini
Hezar Jarib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 8138 yaghini.med.mui.ac.ir Isfahan University of Medical Sciences, child Growth and Development Research Center Iran (Islamic Republic of) Inclusion criteria: Children 3-15 years old with diagnosis of cyclic vomiting syndrome (based on Rome III criteria: 1 Stereotypical episodes of vomiting regarding onset (acute) and duration (less than 1 week); 2) Three or more discrete episodes in the prior year; and 3) Absence of nausea and vomiting between episodes and absence of metabolic, gastrointestinal, central nervous system structural or biochemical disorders); Normal Neurological and Developmental examination Exclusion criteria: Known metabolic disease; Obstructive disease of gastrointestinal or urinary system; Patients who don't give consent to participate in the study or want to leave the study anytime. 3 years 15 years Both R11 Nausea and vomiting Treatment - Drugs Treatment - Drugs Intervention group: In one group we will start topiramate for patients with the dosage of 1-2 mg/kg daily. Patients won't be aware of their drugs. The medication will be used for at list three months during the study. The medication is produced by Pars Daru company in Iran. Control group: In the other group we will start Amitriptyline for patients with the dosage of 1 mg/kg daily. The medication will be used for at list three months during the study. The medication is produced by Pars Daru company in Iran. Severity of cyclic vomiting syndrome. Timepoint: for 3 months after starting the medication. Patients are followed every two weeks after starting the medication. Method of measurement: questionnaire (evaluating number of attacks and duration of attacks). Vice Chancellor for Research of Isfahan University of Medical Sciences Approved 2013-12-02 Ethics Committee of Isfahan University of Medical Sciences Hezar Jarib St. Isfahan Iran (Islamic Republic of)