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IRCT20200126046272N3 IRCT 2020-09-27 Booali Daroo pharmaceutical company Comparison of the Sodium valproate and Sodae herbal capsule effects on migraine pain A comparative survey of the Sodium valproate and Sodae herbal capsule effects on migraine pain 2020-07-22 anticipated 90 Complete https://irct.ir/trial/49469 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block randomization method will be performed with 4 blocks. A colleague will be done a randomization plan and write the code for people, and it remains with the project colleague until the end of the study. First, a list of blocks will be prepared and one number will be assigned to each block, then random numbers will be generated from 1 to 6, and according to these random numbers, the corresponding block will be used, and the list of random allocation of intervention and control will be determined, Blinding description: The researcher and the participants in this study were kept blind. They have no information about the assignment of individuals to groups. 3 migraine. Intervention 1: Intervention group: The intervention group will take one 720 mg sodae capsule made by Boo Ali Daroo Company, with warm water every night before going to bed for three months. Intervention 2: Control group: The control group will take one 720 mg Sodium Valproate with warm water every night before going to bed for three months. Yes - There is a plan to make this available What will be shared: The main implications will be shared after the study is completed. When: 4 month To whom: Upon request, the study results will be made available to other academic researchers. Conditions: People who have the same study and come up with contradictory results that are not rational. Where to obtain: Send email updates for documentation. How to obtain: Documentation will be emailed within a 10-day timeframe. Comments:
public Negin Fakhri
Student Research Committee , School of Public Health, Shahid Bahonar Boulevard
Kermanshah Iran (Islamic Republic of) 6719851351 +98 83 3826 4447 n.fakhri94@yahoo.com Kermanshah University of Medical Sciences scientific Mansour Rezaei
School of Public Health, Dolatabad Boulevard, Isar Square
Kermanshah Iran (Islamic Republic of) 6719851351 +98 83 3826 4447 mrezaei@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Having more than 3 attacks per month in the last three months Having more than 3 attacks at the base time Start migraines at least one year before entering the project Start migraines before age 50 18 years 65 years Both Chronic tension headaches or other headaches for more than 15 days a month Pregnancy, lactation Patients should not be addicted to alcohol or other illegal substances G43 Migraine Treatment - Drugs Treatment - Drugs Intervention group: The intervention group will take one 720 mg sodae capsule made by Boo Ali Daroo Company, with warm water every night before going to bed for three months Control group: The control group will take one 720 mg Sodium Valproate with warm water every night before going to bed for three months. Severity of migraine. Timepoint: Baseline, Three months after the Baseline. Method of measurement: Based on Headache Disability Scale (MIDAS) and Headache Severity Test (HIT6). Kermanshah University of Medical Sciences Booali Daroo pharmaceutical company Booali Daroo pharmaceutical company Approved 2020-09-12 Ethics committee of Kermanshah University of Medical Sciences Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Blvd Kermanshah Kermanshah Iran (Islamic Republic of)