Which one is more effective in cyclic vomiting syndrome treatment? Topitamate or Amitriptyline ?
Phase 2
- Conditions
- Cyclical vomiting syndrome.Nausea and vomiting
- Registration Number
- IRCT2015102316844N2
- Lead Sponsor
- Vice Chancellor for Research of Isfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method