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IRCT20230415057911N1 IRCT 2023-05-21 Iran University of Medical Sciences Comparison of Pregabalin and Cinnarizine on treatment of children with migraine Comparison of Pregabalin and Cinnarizine on prophylactic treatment of children with migraine 2021-06-10 anticipated 74 Complete https://irct.ir/trial/70005 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the block randomization with block size of 4. we used www.sealedenvelope.com website to generate random sequences. The the random list were provided to a epidemiologist who had no involvement in the selection of the type of drug. Then subjects were randomly assigned to two groups of Pregabalin and Cinnarizine, Blinding description: Patient blinding method: Since pregabalin is a capsule and cinnarizine is a tablet, for the similarity of the shape, we put the cinnarizine tablets into powder and inside the pregabalin capsule cover so that both drugs look the same. Doctor's blinding method: The sealed medicine envelopes were given to a researcher who had no involvement in choosing the type of medicine. After the subjects entered the study and their baseline information was collected by the doctor, he sent them to the researcher to get the medicine, and the researcher gave one of the envelopes to the patients, and after that, it was determined in the sheet kept by the researcher that each What medicine did the patient take. 3 Migraine. Intervention 1: The first intervention group: In this group, a Pregabalin oral capsule 50 mg or 75 (manufactured by Actoverco, Iran)mg was prescribed for weight of less than 30 kg and more than 30kg respectively, one time a day for 3 month. Intervention 2: The second intervention group: In this group, a Pregabalin oral capsule 25 mg or 50 (manufactured by Amin pharmaceutical, Iran)mg was prescribed for weight of less than 30 kg and more than 30kg respectively, one time a day for 3 month. 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 There is no further information
public Mohammad Vafaeeshahi
Aliasghar Children's Hospital
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2304 6253 vafaeeshahi.m@iums.ac.ir Iran University of Medical Sciences scientific Mohammad Vafaeeshahi
Aliasghar Children's Hospital
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2304 6253 vafaeeshahi.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Consent of parents and children over 13 years to participate in the study Boys and girls aged 6 to 17 years with migraine prophylaxis Migraine diagnosis based on the criteria of the International Headache Society, which includes cases of migraine without aura (5 attacks), migraine with aura (2 attacks), and each attack lasts 1 to 72 hours, and it is pulsating and severe, and accompanied by symptoms With nausea or vomiting, photophobia, phonophobia Not taking pregabalin and cinnarizine in the past 6 years 17 years Both Drug Intolerance (symptoms such as diarrhea, nausea and vomiting) anaphylaxis severe dizziness excessive sleepiness G43 Migraine Treatment - Drugs Treatment - Drugs The first intervention group: In this group, a Pregabalin oral capsule 50 mg or 75 (manufactured by Actoverco, Iran)mg was prescribed for weight of less than 30 kg and more than 30kg respectively, one time a day for 3 month. The second intervention group: In this group, a Pregabalin oral capsule 25 mg or 50 (manufactured by Amin pharmaceutical, Iran)mg was prescribed for weight of less than 30 kg and more than 30kg respectively, one time a day for 3 month. Frequency of migraine headaches. Timepoint: The beginning of the study, 4, 8 and 12 weeks after the intervention. Method of measurement: Patient's history and notes. Severity of migraine headaches. Timepoint: The beginning of the study, 4, 8 and 12 weeks after the intervention. Method of measurement: Based on the Visual Analogue Scale (VAS). The rate of migraine attacks disability. Timepoint: The beginning of the study, 4, 8 and 12 weeks after the intervention. Method of measurement: Based on Pediatric Migraine Disability Assessment (PedMIDAS) tool. Iran University of Medical Sciences Approved 2021-05-18 Ethics committee of Iran University of Medical Sciences Next to the Milad Tower, Hemmat Highway, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)