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IRCT2015081923685N1 IRCT 2015-10-11 Vice chancellor for research, Qom University of Medical Sciences Comparison of magnesium and sodium valporate in migraine prophylaxis Evaluation of the effectiveness of magnesium compared with sodium valporate in migraine headache prophylaxis 2015-11-22 anticipated 228 Complete https://irct.ir/trial/20200 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Block randomization sampling will be used in this study. N/A Condition 1: Migraine with aura. Condition 2: Migraine without aura. 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: Sodium valporate tablet 200 mg twice a day orally, for 12 weeks. Placebo tablet once a day orally, for 12 weeks. Intervention 3: Intervention group 1: Magnesium tablet 250 mg twice a day orally, for 12 weeks. Placebo tablet once a day orally, for 12 weeks.
public Dr. Samira Khani
East Street No. 2, Moallem Blvd., School of Medicine
Qom Iran (Islamic Republic of) +98 25 3783 2370 pharma_75@yahoo.com School of Medicine , Qom University of Medical Sciences scientific Dr. Seyed Shamsodin Hejazi
Shahid Beheshti hospital , Shahid Beheshti blvd, Qom,
Qom Iran (Islamic Republic of) +98 25 3612 2000 ssh_hejazi@yahoo.com Qom University of Medical Science Iran (Islamic Republic of) 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. 18 years 65 years Both G43.1 G43.0 Migraine with aura [classical migraine] Migraine without aura [common migraine] Treatment - Drugs Treatment - Drugs Treatment - Drugs 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. 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. 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. Vice chancellor for research, Qom University of Medical Sciences Approved 2015-09-07 Ethics committee of Qom University of Medical Sciences No. 83, alley 4 ,St. 1.1, Safashahr Ave., Qom Qom Iran (Islamic Republic of)