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IRCT20180106038242N1 IRCT 2018-02-07 Ahvaz University of Medical Sciences Research ŮŽAssistance Effect of Atorvastatin in Prophylaxis of Migraine Attacks in Patients with Classic Migraine Compared to Standard Treatment Sodium Valproate Effect of Atorvastatin in Prophylaxis of Migraine Attacks in Patients with Classic Migraine 2017-12-22 anticipated 68 Complete https://irct.ir/trial/28730 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The entry of individuals into these groups is done in a completely randomized way. Patients were randomly assigned to a 1: 1 ratio,are blocking with using a randomized technique and with use foursome blocks divided into 2 groups of 34 patients and placebo, Blinding description: Drug and Placebo are Completely Similar in Appearance and Packaging, and Patients Receiving Drug and Placebo , as well as Researchers and People who Collect and Analyze Data are Unaware of Their Nature. 3 Migraine. Intervention 1: Intervention group: Intervention group received daily 200 mg of sodium valproate (a 200 mg tablet of Iran Najo Pharmaceutical Company[Iran]) and 20 mg of Atorvastatin (a 20 mg tablet of Shafa pharmaceutical company [Iran]) for four weeks. Intervention 2: Control group: Received 200 mg of Sodium Valproate (200 mg per day) and placebo tablets similar to Atorvastatin. 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 No more information
public Reza Ganji
Faculty of Pharmacy, Ahvaz University of Medical Sciences, Golestan Blvd
Ahvaz Iran (Islamic Republic of) 6135733184 +98 61 3373 8380 Ganji-r@ajums.ac.ir Ahvaz University of Medical Sciences scientific Reza Ganji
Faculty of Pharmacy, Ahvaz University of Medical Sciences, Golestan Blvd
Ahvaz Iran (Islamic Republic of) 6135733184 +98 61 3373 8380 Ganji-r@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age 18 to 65 years Having at least 3 migraine attacks per month Patients who have fewer than three attacks per month, provided that they affect high-intensity attacks and the patient's life Have a normal serum level of vitamin D3 Patients with classical migraine 18 years 65 years Both Patients who do not sign a form of moral consent. Patients with chronic headaches (more than 15 attacks per month) Patients receiving Statin for other diseases Severe renal failure (GFR <30 ml / min) Creatine Kinase more than 3 times normal Liver enzymes more than twice the normal range The increase in liver enzymes during treatment is more than 3 times the normal Other patients who use drugs other than sodium valproate to treat their migraines and have their disease controlled or sodium valproate, and the disease is under control Pregnant women G43 Migraine Prevention Prevention Intervention group: Intervention group received daily 200 mg of sodium valproate (a 200 mg tablet of Iran Najo Pharmaceutical Company[Iran]) and 20 mg of Atorvastatin (a 20 mg tablet of Shafa pharmaceutical company [Iran]) for four weeks. Control group: Received 200 mg of Sodium Valproate (200 mg per day) and placebo tablets similar to Atorvastatin. Severity of migraine pain according to the Visual Analogue Scale (VAS). Timepoint: The measurement of pain intensity based on the Visual Analogue Scale (VAS) at the beginning of the study (before the intervention) and And one day after the intervention(4 weeks after the onset of Atorvastatin). Method of measurement: Visual Analogue Scale (VAS). The Rate of Migraine Attacks. Timepoint: The question of the history of migraine attacks in a 8-week interval. Method of measurement: Ask The Patient. Ahvaz University of Medical Sciences Research ŮŽAssistance Approved 2017-10-28 Ethics committee of Ahvaz University of Medical Sciences Ahvaz University of Medical Sciences, Golestan Blvd, Golestan Ahvaz Khouzestan Iran (Islamic Republic of)