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IRCT20190208042654N2 IRCT 2020-01-05 Esfahan University of Medical Sciences A comparative study on the efficacy of coenzyme Q10 and amitriptyline in the prophylactic treatment of migraine headaches in children A comparative study of the efficacy of coenzyme Q10 and amitriptyline in the prophylactic treatment of migraine headaches in children; An open-label randomized controlled trial 2019-08-06 anticipated 72 Complete https://irct.ir/trial/43802 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this clinical trial, which begins in summer 2019, 72 participants are selected from the patients referred to the neurology department of Imam Hossein Hospital in a non-randomized and simple method, if they met the inclusion criteria. Adequate explanations will be given to parents and informed consents will be obtained. Patients were randomly assigned using SPSS generated random numbers and binary blocks to either A or B groups (Coenzyme Q10 or Amitriptyline) at the time of administering treatment. In this study, participants will be divided into two groups after allocation of code to each patient and then randomly dividing the codes between two groups and the person in charge is blind to participants, Blinding description: In this study, physicians and patients will aware of study groups and only, statistical analyser will be blind for treatment groups. Each group will be assigned with A or B, making the analyser blind for the treatment groups. 3 Migraine headaches. Intervention 1: Intervention group: Intervention group 1: Coenzyme Q10 is available in the form of 100 mg coated tablets, 30 and 100 mg capsules and 100 mg soft gel. In this study, the dose used is Q10 for children less than 30 kg 30 mg and for children over 30 kg 60 mg and from Eurovital Pharmaceutical Company. Intervention 2: Intervention group: Intervention group 2: Amitriptyline 25 mg tablet of Daroupakhsh industry is available for children. if the dose is greater than 1 -2 mg/kg it will be divided at noon and bedtime. 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 Undecided - It is not yet known if there will be a plan to make this available
public Omid Yaghini
Imam Khomeini street
Isfahan Iran (Islamic Republic of) 81951-63381 +98 31 3234 6022 yaghini@med.mui.ac.ir Esfahan University of Medical Sciences scientific Omid Yaghini
Imam Khomeini street
Isfahan Iran (Islamic Republic of) 81951-63381 +98 31 3234 6022 yaghini@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Children with migraine with or without aura referred to a clinic of neurology and disease is diagnosed definitively on the basis of IHS. Migraine attacks occur at least twice a week or four times a month, forcing them to consume or disrupt their daily activities. Children 5 to 15 year old 5 years 15 years Both Patients' unwillingness to cooperate during the study. Severe and uncontrolled side effects of Q10 or Amitriptyline If a diagnosis other than migraine is made during the study, based on possible laboratory or imaging findings Complicated migraine or epilepsy Lack of ability to record data on the frequency, duration, and severity of headaches Taking prophylaxis other than Q10 and amitriptyline Children with migraines with severe psychiatric problems such as ADHD and depression Using painkillers more than 4 times a week to control migraine attacks (severe forms of migraines) A history of allergy to similar drugs G43 Migraine Prevention Prevention Intervention group: Intervention group 1: Coenzyme Q10 is available in the form of 100 mg coated tablets, 30 and 100 mg capsules and 100 mg soft gel. In this study, the dose used is Q10 for children less than 30 kg 30 mg and for children over 30 kg 60 mg and from Eurovital Pharmaceutical Company. Intervention group: Intervention group 2: Amitriptyline 25 mg tablet of Daroupakhsh industry is available for children. if the dose is greater than 1 -2 mg/kg it will be divided at noon and bedtime. Comparison of the effect of Q10 and amitriptyline on the prophylaxis of migraine headaches. Timepoint: Before intervention, 1,2 and 3 months after intervention. Method of measurement: PedMIDAS quality of life checklist. Esfahan University of Medical Sciences Approved 2019-08-05 Ethics committee of medical science Hezar jarib Ave Isfahan Isfehan Iran (Islamic Republic of)