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IRCT20251020067696N1 IRCT 2025-11-26 Shahre-kord University of Medical Sciences Comparing the effectiveness of magnesium oxide and riboflavin on the prevention of migraine attacks in children Comparing the effectiveness of magnesium oxide and riboflavin on the prevention of migraine attacks in children : A single-blind clinical trial study 2025-11-06 anticipated 70 Complete https://irct.ir/trial/87166 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For this purpose, 70 identical cards, 35 of which have the letter A and 35 of which have the letter B, are placed in a jumbled envelope and one card is randomly drawn for each patient. The letter on the card will indicate the patient's treatment group, Blinding description: For this purpose, 70 identical cards, 35 of which have the letter A and 35 of which have the letter B, are placed in a jumbled envelope and one card is randomly drawn for each patient. The letter on the card will indicate the patient's treatment group. 3 Migraine. Intervention group: Treatment with Magnesium Oxide tablet (9 mg/kg once daily)(39) + Riboflavin tablet (100 mg once daily)(30) for 8 weeks.. 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 No further information is available.
public mehran ansarian
Nurse Street, Hajar Hospital
shahrekord Iran (Islamic Republic of) 8817913645 +98 913 882 5092 ansarian.m157@gmail.com Shahre-kord University of Medical Sciences scientific Mehran Ansarian
No. 10, Amin 12 Alley, Iman Street, West Mirabd District, Shahrekord
Shahrekord Iran (Islamic Republic of) 8817913645 +98 38 3110 7207 ansarian.m157@gmai.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Children aged 6 to 12 years with moderate to mild migraine headaches with or without aura Written informed consent to participate in the study Avoid taking medications that interact with magnesium oxide or riboflavin. No severe neurological disorders or epilepsy No hepatic, renal, gastrointestinal, cardiovascular, or metabolic disorders No tension headaches No history of sensitivity to magnesium oxide or riboflavin No renal failure 6 years 12 years Both Treatment - Drugs Intervention group: Treatment with Magnesium Oxide tablet (9 mg/kg once daily)(39) + Riboflavin tablet (100 mg once daily)(30) for 8 weeks. Average duration of migraine attacks. Timepoint: At the beginning of the study (before starting the intervention) and two months after treatment (end of the study). Method of measurement: Study data will be recorded using a researcher-made checklist that includes: age, sex, body mass index, migraine with and without aura, months since migraine onset, family history of migraine, and the average severity, frequency, and duration of headaches, dizziness, migraine disability criteria, along with the Pediatric Migraine Disability Assessment (PedMIDAS) questionnaire. Time of migraine headache onsetFamily history of migraineFrequency of migraine headache attacksDuration of each episodeHeadache severityNauseaVomitingDizzinessMigraine Disability Assessment Questionnaire (PedMIDAS)Drug side effects. Timepoint: در ابتدای مطالعه (قبل از شروع مداخله) و دو ماه پس از درمان (انتهای مطالعه). Method of measurement: Study data will be recorded using a researcher-made checklist that includes: age, sex, body mass index, migraine with and without aura, months since migraine onset, family history of migraine, and the average severity, frequency, and duration of headaches, dizziness, migraine disability criteria, along with the Pediatric Migraine Disability Assessment (PedMIDAS) questionnaire. Shahre-kord University of Medical Sciences Approved 2025-01-19 The Ethics Committee of Shahrekord University of Medical Sciences, Hajar Hospital Clinical Research parastar st, Hajar Hospital shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)