Condition 1: Migraine with aura. Condition 2: Migraine without aura. Migraine with aura [classical migraine] Migraine without aura [common migraine]
Conditions
Interventions
Treatment - Drugs
Intervention 1: Intervention group 3: Sodium valporate tablet 200 mg once a day orally, for 12 weeks. Magnesium tablet 250 mg twice a day orally, for 12 weeks. Intervention 2: Intervention group 2: So
Intervention group 3: Sodium valporate tablet 200 mg once a day orally, for 12 weeks. Magnesium tablet 250 mg twice a day orally, for 12 weeks
Intervention group 2: Sodium valporate tablet 200 mg twice a day orally, for 12 weeks. Placebo tablet once a day orally, for 12 weeks.
Intervention group 1: Magnesium tablet 250 mg twice a day orally, for 12 weeks. Placebo tablet once a day orally, for 12 weeks.
Sponsors
Vice chancellor for research, Qom University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Samira Khani
School of Medicine , Qom University of Medical Sciences
Outcome results
None listed