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IRCT20200418047116N3 IRCT 2023-09-10 Gonabad University of Medical Sciences Investigating the effect of adding L-carnitine supplement to migraine prophylaxis treatment Investigating the effect of adding L-carnitine supplement to migraine prophylaxis treatment on the symptoms and signs of migraine headaches. 2023-09-23 anticipated 48 Complete https://irct.ir/trial/69278 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In the current study, patients with migraine referred to the neurology clinic of Allameh Bohloul Gonabadi Hospital were selected using available sampling technique. If they want to participate in the study and meet the entry criteria, written and informed consent will be obtained from them. Then, in order to assign the patients to two intervention and control groups, he used the method of quadruple permutation blocks in such a way that first six possible states of the blocks (BAAB, ABBA, BABA, BBAA, ABAB, AABB) were listed and to each block one number of One to six will be allocated and will be used for four patients. Then, a number between one and six is randomly selected using the random number table, and then people are assigned to the control group (A) and the intervention group (B) based on the block corresponding to the selected number. It will continue until the end of the sample size, Blinding description: In the intervention group, L-carnitine tablets of 500 mg once a day will be crushed and placed inside the capsule and will be added to the routine migraine prophylaxis treatment. . In the control group, routine prophylaxis treatment and identical placebo are used instead of L-carnitine. People in both the intervention and control groups will receive the necessary training from the researcher about the objectives of the study, the benefits of studying how and how much to consume L-carnitine, the exclusion criteria, and the duration of the intervention. did The control and intervention groups are marked with two codes A and B, and the outcome evaluation physician and the analyst will not be aware of the nature of these two groups for data analysis. 3 Migraine. Intervention 1: Intervention group: L-carnitine 500 mg tablets of Kharazmi Company are crushed and placed inside the capsule and taken once a day orally for one month to be added to the routine migraine prophylaxis treatment. Intervention 2: Control group: Capsules similar to the intervention group containing 10 mg of starch once a day orally for one month will be added to the routine migraine prophylaxis treatment. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published To whom: The researchers in university and other scientific institutes. Conditions: Applications can be submitted for any project that is useful for the treatment of patients. Where to obtain: Data can be accessible through sending an email to the corresponding author. negar.shafaei@mail.com How to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. Comments:
public Negar Shafaei Bajestani
Allameh Bohlool Gonabadi Hospital, Vahdat Blvd.,Saadi St.
Gonabad Iran (Islamic Republic of) 9691797852 +98 51 5723 6833 negar.shafaei89@gmail.com Gonabad University of Medical Sciences scientific Negar Shafaei bajestani
Saadi St., Vahdat Blvd., Allameh Bohlool Gonabadi Hospital
Gonabad Iran (Islamic Republic of) 9691797852 +98 51 5723 6833 negar.shafaei89@gmail.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Signed informed consent Migraine with or without aura according to the International Classification of Headache Disorders Having 2 or more migraine attacks per month during the past 3 months Migraine onset before age 50 BMI (kg/m2) between 18 and 35 18 years 65 years Both Absence of kidney disease or reduced kidney function and liver cirrhosis No previous use of L-carnitine No use of ≥ 3 prophylactic medications against migraine during the past 5 years No alcohol or illegal drug addiction Not having asthma or vascular disease, arterial lameness Pregnancy, breastfeeding G43.9 Migraine, unspecified Prevention Prevention Intervention group: L-carnitine 500 mg tablets of Kharazmi Company are crushed and placed inside the capsule and taken once a day orally for one month to be added to the routine migraine prophylaxis treatment. Control group: Capsules similar to the intervention group containing 10 mg of starch once a day orally for one month will be added to the routine migraine prophylaxis treatment. Number of days with moderate to severe headache lasting more than 4 hours or treated with usual treatments. Timepoint: Before the intervention and 4 and 8 weeks after the intervention. Method of measurement: check list. Number of days with migraine. Timepoint: Before the intervention and 4 and 8 weeks after the intervention. Method of measurement: check list. Severity of headache on days with headache. Timepoint: Before the intervention and 4 and 8 weeks after the intervention. Method of measurement: MIGSEV scale. Doses of analgesics and triptans. Timepoint: Before the intervention and 4 and 8 weeks after the intervention. Method of measurement: check list. Gonabad University of Medical Sciences Approved 2023-01-09 Ethics committee of Gonabad University of Medical Sciences Imam Khomeini Street, Gonabad University of Medical Sciences Gonabad Razavi Khorasan Iran (Islamic Republic of)