Comparison of magnesium and sodium valporate in migraine prophylaxis
- Conditions
- Condition 1: Migraine with aura. Condition 2: Migraine without aura.Migraine with aura [classical migraine]Migraine without aura [common migraine]
- Registration Number
- IRCT2015081923685N1
- Lead Sponsor
- Vice chancellor for research, Qom University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 228
All patients diagnosed with migraine according to the latest International Headache Society criteria; history of migraine with or without aura for at least 6 months; patient’s age between 18-65 years; at least 2 attacks monthly.
Exclusion criteria: non-migraine headaches (total number of headache days per month more than 15); overuse of analgesics in migraine attacks (consumption of ergots, NSAIDs and triptans more than 8 days a month); substance and alcohol dependence; illiteracy of patients and their family (unable to fill diaries); pregnancy and breast feeding; any previous history of magnesium or sodium valporate intolerance; history of renal, liver and chronic disease; elevated liver enzymes in the first sampling more than 2 times the normal; neurologic disorders other than migraine; use of supplements that contain magnesium, calcium and riboflavin; use of herbal anti-migraine; use of anti-depressant and anti-psychotic medications.
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of hedache. Timepoint: In each migraine attack. Method of measurement: The patient will record the severity of headache in each attack based on Wong-Baker Faces Pain Rating Scale using diary and these notes will be registered every 4 weeks by physician.;Duration of headache. Timepoint: In each migraine attack. Method of measurement: patient will record the hours of headache in each attack , physician will register them every 4 weeks.;Frequency of headaches. Timepoint: every 4 weeks. Method of measurement: According to patients daily notes.;Analgesic use. Timepoint: every 4 weeks. Method of measurement: According to patients daily notes.
- Secondary Outcome Measures
Name Time Method Clinical side effects. Timepoint: every 4 weeks. Method of measurement: According to patient daily notes.;Laboratory side effects (Blood cell count & liver function test changes). Timepoint: before the treatment course and at the end of 12 weeks. Method of measurement: lab tests.