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IRCT20220124053815N1 IRCT 2023-02-12 Shahre-kord University of Medical Sciences Investigating the effect of migrafar (Tanacetum parthenium) on migraine pain in children are treating with amitriptyline Investigating the effect of migrafar (Tanacetum parthenium) on migraine pain in children are treating with amitriptyline 2022-12-06 anticipated 50 Complete https://irct.ir/trial/62666 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization will be simple. The randomization unit is individual. First, number the size of the sample from 1 to 50 on the paper (the number of papers is equal to 50 and they will be numbered from 1 to 50) and We put these papers in a box. With random allocation software, the members of the sample are divided into two groups, equal to the sample size and randomly in groups. Also, the software randomly generates numbers that will represent the studied group of people. Software address: https://random-allocation-software.software.informer.com/2.0/ Each person who enters the study randomly draws a number from the box and will be studied in one of two groups according to the number he/she takes out of the box. (The numbers inside the box are divided into two groups by the software. And that means, for example, the software has determined that the number 6 should enter the second group, when the subject selects the number 6 from the box, it will enter the second group), Blinding description: Our study will be a one-sided blind study. In this study, the parents and children receiving the medicine will not know about the type of medicine received. The researcher and other people will have complete knowledge about the prescription drugs for each group. Also, the statistical analyst will also He will be aware of the groups and type of medicine received. 3 Headache, migraine. Intervention 1: Intervention group: The group receiving the standard drug Amirtriptyline along with Migrafar capsules (prepared and provided by Nutek Far Pharmaceutical Company), which receives one or two capsules daily based on age. Intervention 2: Control group: the group receiving the standard drug Amirtriptyline along with Migrofar placebo capsule (which is prepared and provided by Nutekfar pharmaceutical company), which receives one or two capsules daily based on age. Yes - There is a plan to make this available What will be shared: To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy will be published. When: The access period will start 6 months after the results are published. To whom: Our data will only be available to researchers working in academic and scientific institutions Conditions: If there are conditions, all our data will be shared except personal information of people. The use of our data will only be allowed for similar research and review of our data by other researchers. All those who work in universities and scientific centers and decide to conduct similar research or check the accuracy of our data can access our data. Where to obtain: In order to receive information, all eligible people can collect data by referring to the person in charge of the project. The contact methods are the email address mehdi.sadeghi.68@gmail.com or the contact number 009891103122195. How to obtain: To receive information after sending the request, the requests will be reviewed within 10 days. If the above conditions are met, the information will be sent to the provided email within 30 days at most. Comments:
public Mehdi Sadeghi
Kashani street
Shahre kord Iran (Islamic Republic of) ۸۸۱۳۸۳۳۴۳۵ -۳۳۳۳۵۶۵۲-۰۳۸ mehdi.sadeghi.68@gmail.com Shahre-kord University of Medical Sciences scientific Mehdi Sadeghi
Kashani street
Shahre kord Iran (Islamic Republic of) ۸۸۱۳۸۳۳۴۳۵ -۳۳۳۳۵۶۵۲-۰۳۸ mehdi.sadegi.68@gmail.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of primary headache Mild to moderate headache intensity Age range from 6 to 18 years Absence of secondary cause for headache Not taking any other medicine for headache 6 years 18 years Both Uncertain diagnosis of headache G43 Migraine Treatment - Drugs Placebo Intervention group: The group receiving the standard drug Amirtriptyline along with Migrafar capsules (prepared and provided by Nutek Far Pharmaceutical Company), which receives one or two capsules daily based on age. Control group: the group receiving the standard drug Amirtriptyline along with Migrofar placebo capsule (which is prepared and provided by Nutekfar pharmaceutical company), which receives one or two capsules daily based on age. The intensity of the headache will be measured by Visual Scale Questionnaire (VAS). Timepoint: At the beginning and three months after taking the medicine, we check the result. Method of measurement: Visual Analogue Scale. Number of headaches. Timepoint: At the beginning of the research and three months after receiving the drug. Method of measurement: Number of daily headaches. Type of headache. Timepoint: At the beginning of the research and three months after receiving the drug. Method of measurement: To be pulsatile or non-pulsatile. Location of headache. Timepoint: At the beginning of the research and three months after receiving the drug. Method of measurement: Unilateral or bilateral. Shahrekord Medical University Approved 2021-05-17 Ethics Committee of Shahrekord University of Medical Sciences Kashani street Shahre kord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)