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IRCT20230823059240N1 IRCT 2023-12-18 Qazvin University of Medical Sciences Efficacy of Riboflavin and Amitriptyline in Migraine Attack Efficacy of Riboflavin and Amitriptyline in Frequency and Intensity of migraine Attack in Patients with Migraine Headache 2023-09-11 anticipated 36 Complete https://irct.ir/trial/72348 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Based on random allocation, these patients are divided into two groups: amitriptyline and riboflavin (200 mg). Patients are divided in to two treatment groups A and B using the method of random blocks (Balance block randomization), the size of each block is 6 and the total number of blocks is 12. Blocking is usually used in order to balance the number of samples allocated to each of the studied groups. This feature helps researchers to ensure that the number of samples assigned to each of the study groups is equal in cases. Blocking is carried out in two ways. In the first method, the size of all the blocks is equal (for example, in a two-group experiment, blocks of 8 including 4 participants in the intervention group and 4 participants in the control group) and in the second method, the size of the blocks is randomly selected (for example, blocks 6, 8, 10 and 14 which are available in each block in equal numbers from each group). The method of allocation of balanced randomization for the participants in the randomized controlled clinical trial study is the effect of riboflavin with a dose of 200 mg (group A) and amitriptyline with a dose of 25 mg (group B) to evaluate the frequency and severity of attacks, Blinding description: This study was designed as a single blind. Participants have completely informed about the implementation of the study, the duration of follow-up, the drugs, and the side effects and advantages of the studied drugs, as well as the studies conducted in this field by someone from the health care services who is fully involved, and the main researcher does not know how to selected patients divided in each group. Data analysis and data collection are also conducted by the project researcher, who has not informed about the project and randomization. 2-3 Migraine Headche. Intervention 1: Intervention group: this study, riboflavin (from Flaviran brand) has administrated to patients at a dose of 200 mg divided into two doses of 100 mg (every 12 hours) up to 3 months (sample number: 36 patients). The side effects and advantages of riboflavin has investigated and the patients enrolled to this study voluntarily after filling out the consent form and initial questionnaire. Intervention 2: Control group: In this study, amitriptyline has administrated to patients at a single dose of 25 mg up to 3 months (sample number: 36 patients). The side effects and advantages of amitriptyline has investigated and the patients enrolled to this study voluntarily after filling out the consent form and initial questionnaire. 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 the data of participants are private and after permission of them and if there is urge reasons, we can provide the details.
public Reza Gorji
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin, Iran
Qazvin Iran (Islamic Republic of) 34197-59811 +98 28 3335265 r.gorji@qums.ac.ir Qazvin University of Medical Sciences scientific Forough Ebrahimtabar
Department of Neurology, Bu Ali Sina Hospital, Qazvin University of Medical Sciences, Qazvin, Iran
Qazvin Iran (Islamic Republic of) 34197-59811 0098283332930 forouq_ebr_95@yahoo.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Migraine with or without aura based on IHS criteria Migraine history since the last year Migraine with frequency of 2 to 8 times per month or at least 2 days of headache per month Patient's age should be between 18 to 65 years old The migraine headache must be completely distinguished from other types 18 years 65 years Both Tension headache or other types more than 15 times a month Daily recipient of painkillers more than 15 times a month Patients who received more than 3 complete prophylaxis trials and did not respond to prophylactical treatment Pregnancy or planning for pregnancy Taken another prophylaxis medicine for less than a month Drug abruptions (drug reaction) Patients who don't want to continue the treatment or stop the medication receipt Patients who referred not for further evaluation G43 Migraine Treatment - Drugs Placebo Intervention group: this study, riboflavin (from Flaviran brand) has administrated to patients at a dose of 200 mg divided into two doses of 100 mg (every 12 hours) up to 3 months (sample number: 36 patients). The side effects and advantages of riboflavin has investigated and the patients enrolled to this study voluntarily after filling out the consent form and initial questionnaire. Control group: In this study, amitriptyline has administrated to patients at a single dose of 25 mg up to 3 months (sample number: 36 patients). The side effects and advantages of amitriptyline has investigated and the patients enrolled to this study voluntarily after filling out the consent form and initial questionnaire. Comparison of effects on headache indices (duration, severity of clinical symptoms, and frequency of attacks) in riboflavin and amitriptyline groups and comparison of riboflavin and amitriptyline headache indices in the period of one, three months from the start of treatment and investigation of side effects caused by Taking study drugs. Timepoint: In this study, the headache indices in two groups of riboflavin and amitriptyline are investigated in the period of one and three month after starting the treatment. Method of measurement: In both groups, based on a checklist of patients' demographic information, as well as information related to occupation, duration of headache, type of previously used medication, headache intensity (PAIN SCALE), frequency of attacks per month, number of days of attack and co-morbidity of DM, HTN, VASCULAR DISORDER, PSYCHIATRIC DISORDER, GI DISORDER) are fulfilled by patients in both groups. Patients in the first group (A) has administrated riboflavin at a dose of 100 mg twice a day, and the other group (B) has administrated amitriptyline at a single dose of 25 mg. Then both groups are re-evaluated again after one and three months later in terms of headache indicators. Also, the drug side effects considered in the study including (diarrhea, nausea, vomiting and polyuria) are investigated. Qazvin University of Medical Sciences Approved 2023-07-16 Ethics Committee of Qazvin University of Medical Sciences Neurology Department, Bu ali Sina Hospital, South Naderi St., Qazvin, Iran Qazvin Qazvin Iran (Islamic Republic of)