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IRCT20180223038830N1 IRCT 2019-07-20 Ahvaz University of Medical Sciences Effect Of IV Sodiom Valproate in Migraine , Effect of IV Dexametazon in Migraine Comparison of the Effectiveness of IV Sodiom Valproate in contrast to IV Dexametazon for treatment of patient with severe Migraine Headache 2019-03-21 anticipated 108 Complete https://irct.ir/trial/29817 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study , range of patients , body weight (50- 80 kg) is one of our parameters , so that , this has not been in any other same studies, Randomization description: Simple randomization , based on ETCETERA Version 3.26 ,Balanced randomization [module A3], Blinding description: The research pharmacist will prepare 108 uniform and unishape boxes , which 54 those medications are 1200 mg Na Valproate ,and the rest of 54 medications are 8 mg Dexametason that will be placed into sequentially numbered from 101 to 208 , in order determined by balanced allocation of 108 subjects to groups A and B . Patients that will be enrolled to the study , if they would have inclusion criteria and not have any exclusion criteria , who will be numberd from 101 to 208 respectively . 3 Condition 1: Migraine without aura(common migraine). Condition 2: Migraine with aura ( classic migraine ). Intervention 1: Intervention group: Sodiom Valproate (Depakine), manufactured by Sanofi S.P.A./Italy , 1200 mg in 250 cc Normal Salin , administerd intravenously over 15 minutes for the patients. Intervention 2: Control group: Dexamethasone ,manufactured by Iran Hormone Pharmaceuticals , 8 mg in 250 cc Normal Salin ,administerd intravenouslyover 15 minutes for the patients. 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 I do not have any plan to release detail yet.
public Mohammad Reza Dadkhah Tehrani
Farvradin
Ahwaz Iran (Islamic Republic of) 61357-33118 +98 61 3374 3001 dadkhahtehrani.m@ajums.ac.ir Ahvaz University of Medical Sciences scientific Fateme Tirandaz
Farvardin
Ahwaz Iran (Islamic Republic of) 61357-33118 +98 61 3374 3001 Fatemetirandaz@gmial.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) The chief complaint of patients is acute headache. Positive past history of Migraine headache Intensity of headache equal or more than four base on VAS score Age equal or more than 18 to less or equal than 58 years old. Body weight equal or more than 50 to less or equal than 80 kg. 18 years 58 years Both BP more than 160/100 mmHg SBP less than 100 mmHg PR less than 50 /Min Pregnancy or lactation Presens of systemic disease( Cardiovascular ,Pulmonary ,Metabolic ,Liver &Renal insufficiency ,Cancer ,Seizure ) Use of Anticoagolant & Anticonvulsant & Antimetobolit drugs. Use of any IV sedative drugs in 4 h. ago. Use of Ergot &Triptamin component recently to 24 h. Positive history of hypersensitivity to Dexamethazon & Sodiom Valproate G43.0 G43.1 Migraine without aura Migraine with aura Treatment - Drugs Treatment - Drugs Intervention group: Sodiom Valproate (Depakine), manufactured by Sanofi S.P.A./Italy , 1200 mg in 250 cc Normal Salin , administerd intravenously over 15 minutes for the patients. Control group: Dexamethasone ,manufactured by Iran Hormone Pharmaceuticals , 8 mg in 250 cc Normal Salin ,administerd intravenouslyover 15 minutes for the patients. Decrease of Migrainuos Headache severity and related symptoms,. Timepoint: 0.5 , 1 , 2 hour after use of medication,. Method of measurement: VAS score. Ahvaz University of Medical Sciences Approved 2017-12-19 Ethics committee of Ahwaz JondiShapour University of Medical Sciences Farvardin St. ŮŽAhwaz Khouzestan Iran (Islamic Republic of)