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IRCT20180724040576N1 IRCT 2018-11-08 Shiraz University of Medical Sciences Effect of cinnarizine in control of pediatric migraine Comparison of propranolol plus cinarizine and propranolol plus placebo in control of migraine headaches in children attending Imam Reza clinic in Shiraz. 2018-11-22 anticipated 106 Complete https://irct.ir/trial/33947 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients are assigned into two groups by simple random sampling procedure.A number or code is devoted to each patient. Codes are produced by statistician using digit random tables. Codes are not deciphered till the end of study. when a patient is found eligible by pediatric neurologist, he/she is referred to staff nurse, and after obtaining informed consent form, and a code from statistician, the drug package is given to the parents , Blinding description: Patients, physicians and staff nurses are unaware of the type of treatments received. Just the project statistician is aware of the codes. 3 Pediatric migraine. Intervention group: Cinnarizine(37.5 mg for children 4-11 years of age and 50 mg for children 12-16 years of age, once daily) and Propranolol (1 mg /kg body weight, once daily). Duration of treatment is 8 weeks.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Pegah Katibeh
Imam Reza clinic, Namazi square
Shiraz Iran (Islamic Republic of) 71348714737 +98 71 3212 7522 katibeh_p@sums.ac.ir Shiraz University of Medical Sciences scientific Pegah Katibeh
Imam Reza Clinic, Namazi square
Shiraz Iran (Islamic Republic of) 71348714737 +98 71 3212 7522 katibeh_p@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Every child with a diagnosis of migraine (according to international headache society) There must be at least 4 episodes of migraine attacks per month. The age range of 6 to 14 years. A migraine headache with or without aura. The patient has not used any drug for preventing migraine headaches during last month Parents agreement and sign informed written consent form. 6 years 14 years Both The patient affected by other forms of migraine headache (variant migraine). The patient has focal neurologic signs or radiologic findings in brain imaging. There is a serious comorbidity. There are other systemic diseases. Inability to participate in the study. Use of drugs for preventing attacks during last month A contraindication to use of cinnarizine or propranolol (such as asthma or heart block). G43 Migraine Treatment - Drugs Intervention group: Cinnarizine(37.5 mg for children 4-11 years of age and 50 mg for children 12-16 years of age, once daily) and Propranolol (1 mg /kg body weight, once daily). Duration of treatment is 8 weeks. Frequency of migraine headaches. Timepoint: Before intervention and 2,4,8 weeks after intervention. Method of measurement: Frequency of headaches will be recorded daily by the parents in a timetable. Severity of migraine headaches. Timepoint: Before intervention and 2,4,8 weeks after intervention. Method of measurement: Severity of headaches will be measured by Visual Analog Scale. Shiraz University of Medical Sciences Approved 2018-01-15 Ethics committee of Shiraz Medical School Setad square, Zand avenue Shiraz Fars Iran (Islamic Republic of)