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IRCT20230409057857N1 IRCT 2023-05-02 Arak University of Medical Sciences Investigating the effect of evening primrose oil on reducing the severity of headache and disability due to menstrual migraine Investigating the effect of evening primrose oil on reducing the severity of headache and disability due to menstrual migraine 2023-05-31 anticipated 40 Complete https://irct.ir/trial/69485 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, randomization will be done using the block randomization method. A block size of 4 is considered. Therefore, we will have 6 blocks in the following order: AABB (1), ABAB (2), ABBA (3), BBAA (4), BABA (5), BAAB (6), each of which is numbered and addresses 4 patients. will be used; That is, if block number 2 is selected in the lottery, the first patient will receive treatment A (morangiola), the second patient will receive treatment B (placebo), the third patient will receive treatment A (morangiola) and the fourth patient will receive treatment B (placebo). The fifth patient will be randomly selected from one of the blocks and the type of treatment will be allocated to the fifth to eighth patients according to the block, and this process will be repeated until the end of sampling. The lottery is also done in such a way that the numbers of the blocks are written in folded papers and then another person (other than the researcher) takes one of the papers each time to determine the block number, Blinding description: In this study, the doctor, the patient, and the statistical analyst are not aware of the allocation of patients in the intervention and control groups. In this way, the specialist doctor only examines the patients according to the criteria of the International Headache Society (IHS) to meet the conditions for entering the study, but is not involved in the randomization of their allocation; This is done by an intern colleague. In order to avoid the knowledge of the patients, the drug and placebo (which look the same) are removed from their original packaging and placed in paper packages of the same shape so that they cannot be distinguished. Also, in order to avoid the knowledge of the statistical analyst, the control and intervention groups are marked with code one and two, so that only the intern (researcher) is aware of the control and intervention groups. N/A menstrual migraine. Intervention 1: Intervention group: intervention group receives common treatments (including sodium valproate 200 mg twice a day and nortriptyline 25 mg daily) along with 2 pearls 1000 mg evening primrose oil manufactured by Barij Essential Oil Company of Iran from 5 days before to 5 days after for 3 months. The headache severity visual scale questionnaire and the migraine disability severity questionnaire are completed before the intervention and by a researcher in the form of questions from the patients and after 90 days of drug administration. After data collection, statistical analysis will be done using SPSS version 22 software and related statistical tests. Intervention 2: Control group: The control group receives common treatments (including sodium valproate 200 mg twice a day and nortriptyline 25 mg daily) along with 2 pearl placebo daily from 5 days before to 5 days after menstruation for 3 months.The headache severity visual scale questionnaire and the migraine disability severity questionnaire are completed before the intervention and by a researcher in the form of questions to the patients and after 90 days of drug administration. After data collection, statistical analysis will be done using SPSS version 22 software and related statistical tests. 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 There is no further information
public Farzaneh Mohammadi
Masumeh dormitory, Medical science university of Arak, Sardasht Avenue, Arak town
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3036 farzane.mo.1998@gmail.com Arak University of Medical Sciences scientific Farzaneh Mohammadi
Masumeh dormitory, Medical science university of Arak, Sardasht Avenue, Arak town
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3036 farzane.mo.1998@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Age 18 to 55 years old Certain menstrual migraine diagnosed based on IHS classification and the neurologist opinion Not using other drugs (psychoactive and opiate ) Not suffering from another chronic illness except migraine Getting informed consent 18 years 55 years Female G43.82 Menstrual migraine, not intractable Treatment - Drugs Placebo Intervention group: intervention group receives common treatments (including sodium valproate 200 mg twice a day and nortriptyline 25 mg daily) along with 2 pearls 1000 mg evening primrose oil manufactured by Barij Essential Oil Company of Iran from 5 days before to 5 days after for 3 months. The headache severity visual scale questionnaire and the migraine disability severity questionnaire are completed before the intervention and by a researcher in the form of questions from the patients and after 90 days of drug administration. After data collection, statistical analysis will be done using SPSS version 22 software and related statistical tests. Control group: The control group receives common treatments (including sodium valproate 200 mg twice a day and nortriptyline 25 mg daily) along with 2 pearl placebo daily from 5 days before to 5 days after menstruation for 3 months.The headache severity visual scale questionnaire and the migraine disability severity questionnaire are completed before the intervention and by a researcher in the form of questions to the patients and after 90 days of drug administration. After data collection, statistical analysis will be done using SPSS version 22 software and related statistical tests. Severity of headache and degree of disability caused by menstrual migraine. Timepoint: Before the intervention, 3 months after the intervention. Method of measurement: Visual Analogue Scale, Migraine Disability Assessment. Arak University of Medical Sciences Approved 2023-03-19 Ethics Committee of Arak University of Medical Sciences Masumeh dormitory, Medical science university of Arak, Sardasht Avenue, Arak town Arak Markazi Iran (Islamic Republic of)