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IRCT20191112045413N1 IRCT 2020-01-24 Tehran University of Medical Sciences Comparison the Effect of Cinnarizine and Amitriptyline in Pediatric Migraine Comparison the Effect of Cinnarizine and Amitriptyline in Pediatric Migraine Prophylaxis of Children Referring to Children Medical Center Hospital: a Randomized Clinical Trial 2019-12-06 anticipated 70 Complete https://irct.ir/trial/43606 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation: Patients will be randomly assigned to two groups of cinnarizine and amitriptyline. The random allocation method of these two groups is block randomization and block size is considered 6 persons and we are using Random allocation software for this process. This sequence will be kept secret with the clerk secretary. None of the participants in the study will be aware of the randomization list and for this purpose we will use color-numbered folders, which will be kept by the clerk secretary who is the only one that know about the allocation groups, Blinding description: This is a double blind study. Patients and practitioners and annalist will be unaware of the type of treatment assigned. In order to blind the executive staffs, those applying the treatment will be different from those responsible for examining and evaluating patients. Drug packages will also be labeled according to a specific code. Only the clinic secretary will be informed of the type of drug that patients receive. 3 میگرن. Intervention 1: First Intervention group: patients receiving Cinnarizine 25 mg, start with one half of tablet each night and after 10 days, increase to one complete tablet each night, for 3 consecutive months. Intervention 2: Second intervention group: patients receiving Amitriptyline 25 mg, start with one half of tablet each night and after 10 days, increase to one complete tablet each night, for 3 consecutive months. Yes - There is a plan to make this available What will be shared: All the information about outcomes will be published When: 6-12 months after publication To whom: Researcher of academic institute Conditions: The data of our study will be accessible by other researchers, for conducting Meta-analysis Where to obtain: No decision is made yet How to obtain: The researchers should explain the aims of their study. The request will be assessed by our team, and if we agree to the request, the requested data will be emailed. Comments: No further explanation
public Mehrnaz Olfat
No. 14, Banaei Street, Davoud Armaghani Ave., Damavand Blvd.
Tehran Iran (Islamic Republic of) 1643814551 +98 21 7703 7596 olfat.mehrnaz@gmail.com Tehran University of Medical Sciences scientific Mehrnaz Olfat
No. 14, Banaei Street, Davoud Armaghani Ave., Damavand Blvd.
Tehran Iran (Islamic Republic of) 1 +98 21 7703 7596 olfat.mehrnaz@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Having experienced one or more migraine attacks per month or severe dysfunction in daily and school activities 4 years 18 years Both Use of prophylactic migraine therapy in at least one previous month Focal Neurologic Deficit Known concomitant serious diseases (hepatic, renal, etc) G43 Migraine Treatment - Drugs Treatment - Drugs First Intervention group: patients receiving Cinnarizine 25 mg, start with one half of tablet each night and after 10 days, increase to one complete tablet each night, for 3 consecutive months. Second intervention group: patients receiving Amitriptyline 25 mg, start with one half of tablet each night and after 10 days, increase to one complete tablet each night, for 3 consecutive months. Percent of patients who the severity of their headache episodes decreased to less than 50% of baseline. Timepoint: One month before to 3 months after initiation of treatment. Method of measurement: Visual Analogue Scale and Visual Pain Scale. Percent of patients who the frequency of their headache episodes decreased to less than 50% of baseline. Timepoint: One month before to 3 months after initiation of treatment. Method of measurement: By charting all the headache episodes by detail in the special checklist. Percent of patients who the duration of their headache episodes decreased to less than 50% of baseline. Timepoint: One month before to 3 months after initiation of treatment. Method of measurement: By charting all the headache episodes by detail in the special checklist. Quality of life scoring. Timepoint: One month before to 3 months after initiation of treatment. Method of measurement: PedMIDAS questionnaire. Tehran University of Medical Sciences Approved 2019-07-09 Ethics committee of Tehran University of Medical Sciences District 6, Keshavarz Boulevard and Ghods St. crossing. Main Office of Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)