migraine. migraine
Conditions
Interventions
Intervention 1: Twenty mg/kg/day valproate sodium daily in 2 divided doses with one omega-3 capsule contain of 1 gr fish oil, Produced by Zahravi Pharmaceutical Company, for 3 months (intervention).
Treatment - Drugs
Placebo
Twenty mg/kg/day valproate sodium daily in 2 divided doses with one omega-3 capsule contain of 1 gr fish oil, Produced by Zahravi Pharmaceutical Company, for 3 months (intervention)
Twenty mg/kg/day valproate sodium daily in 2 divided doses with one placebo capsule (as the same color, package, and shape as omega-3 capsule without any active ingredient, Produced by Zahravi Pharmac
Sponsors
Vice Chancellor for Research and Technology, Hamedan University of Medical Science
Eligibility
Sex/Gender
All
Age
5 Years to 14 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1.children in 5-14 years old age 2.Having migraine headache based on International Headache Society Criteria 3.Having frequent or disabling headaches that prophylactic therapy indicated in them (one or more headache attack per week or, three or more headache attacks per month or, more than one school day lost per month) Exclusion Criteria: 1.Diagnosis changes each time during the study 2.Secondary headaches or other neurologic disorders 3.Not to use drugs correctly
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Monthly frequency of headache. Timepoint: Before and after three months of treatment. Method of measurement: Asking from patient.;Severity of headache. Timepoint: Before and after three months of treatment. Method of measurement: Asking from patient.;Pediatric Migraine Disability Grade (pedMIDAS). Timepoint: Before and after three months of treatment. Method of measurement: Asking from patient.;Clinical general impression. Timepoint: Before and after three months of treatment. Method of measurement: Asking from patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| Omega-3 side effects including gastrointestinal side effects and allergy. Timepoint: Monthly until three months of treatment. Method of measurement: Clinical exam and asking from patients. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAfshin Fayyazi
Hamedan University of Medical Science, School of Medicine
Outcome results
None listed