]>
IRCT20221115056506N1 IRCT 2023-02-06 Shiraz University of Medical Sciences Evaluation of magnesium effect in treatment of migraine Evaluation of the prophylactic effect of magnesium versus placebo in reduction of frequency, severity and duration of migraine headaches in children aging 6-18 years old 2023-02-09 anticipated 140 Complete https://irct.ir/trial/66871 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is performed via block randomization method comprising 35 blocks of 4 individuals using statistical software and, the random sequence of the study is made beforehand. allocation concealment is ensured by putting unique patient-numbers on medication packets and, delivered to the patient upon entering to the study according to the random sequence while, researcher is unaware of the allocation, Blinding description: Initially, informed consent, demographic and baseline information are obtained. Patient and physician are blind to the intervention groups. Patients' allocated groups are written down in a notebook by physician assistant and will be revealed at the end of the study. Randomization is performed by the assistant and medication delivery is done in the clinic by another assistant. Magnesium oxide pills and placebo are given in identical small packets with identical labeling. Propranolol tablets are given in its standard factory-made packages. 3 Migraine. Intervention 1: Intervention group: Magnesium oxide 10 mg/kg in 1 or 2 divided dose for 3 months should be used. Generic Magnesium Oxide 250 mg tablets from Jalinus pharmaceutical company are used. patients are also provided with Propranolol 0.5 mg/kg/day. Intervention 2: Control group: Placebo with complete resemblance to magnesium oxide pills with similar usage order produced by the pharmaceutical laboratory of Shiraz school of pharmacy. patients are also provided with Propranolol 0.5 mg/kg/day. Yes - There is a plan to make this available What will be shared: All patients' data would be available after anonymization. When: Data would be available to public after publication of the article. To whom: Data is only provided for scientific purposes to researchers. Conditions: Data will be available for research purposes. Where to obtain: Please contact Dr. Pegah Katibeh or Dr. Mohammad Akrami via Email. How to obtain: After evaluation of request, data will be provided in fastest time possible and no specific legal pathway is in consideration. Comments:
public Pegah Katibeh
Zand Blvd.
Shiraz Iran (Islamic Republic of) 7193711351 +98 71 3612 5849 Pegah_katibeh@yahoo.com Shiraz University of Medical Sciences scientific Pegah Katibeh
Zand Blvd.
Shiraz Iran (Islamic Republic of) 7193711351 +98 71 3612 5849 Pegah_katibeh@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Age from 6 to 18 years old Weight less than 90 Kg Diagnosed as migraine according to IHSC-3 criteria At least 4 migraine attacks in month or 8 days-of-headache during at least 1 month ago 6 years 18 years Both Coexistence of another type of headache Migrainous headache in at least 15 days per month Using analgesic medications in at least 15 days per month Pregnancy or intention of pregnancy History of epilepsy or other neurological comorbidities Mental retardation defined as IQ<70 Dependency or addiction to pharmaceutical or illicit drugs Magnesium administration contraindications Renal failure History of renal stone Propranolol administration contraindications Cardiac conduction block Bradycardia History of asthma History of hypersensitivity reaction to propranolol Diabetes mellitus Liver insufficiency Myasthenia gravis Psoriasis History of using migraine prophylaxis medications in the past month History of using magnesium supplements in the past month History of psychiatric disorders including depression, mood disorders, anxiety disorders or psychotic disorders History of using anti-depressants, anti-psychotics, mood stabilizers or sedatives Anticipation of patient's poor medication compliance Illiteracy of the patient and family and, inability of filling the diary G43 Migraine Treatment - Drugs Placebo Intervention group: Magnesium oxide 10 mg/kg in 1 or 2 divided dose for 3 months should be used. Generic Magnesium Oxide 250 mg tablets from Jalinus pharmaceutical company are used. patients are also provided with Propranolol 0.5 mg/kg/day. Control group: Placebo with complete resemblance to magnesium oxide pills with similar usage order produced by the pharmaceutical laboratory of Shiraz school of pharmacy. patients are also provided with Propranolol 0.5 mg/kg/day. Frequency of migraine attacks per month. Timepoint: At the beginning; then, 4 weeks later; then, 12 weeks after the initiation. Method of measurement: Direct asking of the patient in the first visit; then, using migraine diary in the following visits. Severity of pain during migraine attacks. Timepoint: First visit; 4 weeks later; 12 weeks later. Method of measurement: Wong-baker scale. Average duration of migraine attacks per month. Timepoint: First visit; 4 weeks later; 12 weeks later. Method of measurement: direct asking and migraine diary. Amount of analgesic medications used. Timepoint: First visit; 4 weeks later; 12 weeks later. Method of measurement: direct asking and migraine diary. Shiraz University of Medical Sciences Approved 2022-07-04 Ethics committee of Shiraz University of Medical Sciences Zand Blvd. Shiraz Fars Iran (Islamic Republic of)