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IRCT20190619043946N1 IRCT 2020-03-09 Hamedan University of Medical Sciences Comparison the effect of melatonin plus propranolol and propranolol on the improvement of symptoms of migraine headache with sleep disorders in children Comparison the effect of melatonin plus propranolol and propranolol on the improvement of symptoms of migraine headache with sleep disorders in children 2019-03-21 anticipated 10 Complete https://irct.ir/trial/41049 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The quadruple block method is used for randomization in this trial. How to randomize is AABB, ABAB, BABA, BBAA,. The randomization unit is individual. Codes are assigned to the samples for concealment. N/A Migraine and sleep disorders. Intervention 1: Intervention group: Consumption of propranolol with dosage 1 mg / kg divided into 2 doses Along One tablet of melatonin 3 mg daily for three months. Intervention 2: Control group: Consumption of propranolol alone with dosage 1 mg / kg divided into 2 doses for three months. 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 It is necessary to obtain the necessary permissions
public Abbas Ali Abdollahi
Hamedan Fatemi Boulevard
Hamadan Iran (Islamic Republic of) 6514845411 +98 81 3264 0064 abbasali.abdollahi@yahoo.com Hamedan University of Medical Sciences scientific Abbas Ali Abdollahi
Hamedan Fatemi Boulevard
Hamadan Iran (Islamic Republic of) 6514845411 +98 81 3264 0064 abbasali.abdollahi@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) 1- Children aged 5 to 15 years 2. A definitive diagnosis of migraine disease by a neurologist. 3- Rejection of other causes of headache 4. Family consent to attend the project 5. Suitable for the onset of migraine prophylaxis: more than one attack per week, more than a disabling attack (leading to school absenteeism or dysfunction, PEDMIDAS of more than 20 6. Sleep disturbance includes: late sleep, early waking, low sleep, frequent waking up during nighttime sleep. 5 years 15 years Both 1-For any reason, patients tend to continue to study or change the diagnosis. 2- Cases of other underlying illnesses that do not have the ability to use propranolol. G43 Migraine Treatment - Drugs Treatment - Drugs Intervention group: Consumption of propranolol with dosage 1 mg / kg divided into 2 doses Along One tablet of melatonin 3 mg daily for three months Control group: Consumption of propranolol alone with dosage 1 mg / kg divided into 2 doses for three months Migraine. Timepoint: Patients are evaluated 1 month after treatment and in those who continue to receive treatment at the end of the first three months the rate of recovery is assessed. Method of measurement: The severity of migraine headaches is assessed using the PEDMIDAS method. Sleep disorders. Timepoint: Patients are evaluated 1 month after treatment and in those who continue to receive treatment at the end of the first three months the rate of recovery is assessed. Method of measurement: Child Sleep Disorder will be assessed using the CSHQ Child Sleep Habits Questionnaire. Hamedan University of Medical Sciences Approved 2019-06-18 National Ethics Committee for Biomedical Research Tehran-Ghods Town (West) - Between South Falamak and Zarafshan, Iran's Sims Avenue-Headquarters of the Ministry of Health and Medical Education, block A, thirteenth floor Tehran Tehran Iran (Islamic Republic of)