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IRCT20090412001808N6 IRCT 2019-12-03 Mazandaran University of Medical Sciences Effect of melatonin on refractory seizure of children Clinical trial of the effect of melatonin on children with refractory seizure 2019-04-15 anticipated 50 Complete https://irct.ir/trial/43561 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned to two groups of intervention and control using block randomization with block sizes of 4. Randomization will be done using the software randomization option in Excel. The randomization process is performed by the study methodology consultant and clinical researchers are not aware of the randomization process, Blinding description: Since the placebo capsule has the same shape, color, and taste of the intervention drug, the patient is blind and unaware of the drug being used. 3 Refractory seizure. Intervention 1: Intervention group: The intervention group will be prescribed melatonin tablet at a dose of 10 mg/m2 body surface area in the form of a 3 mg tablet manufactured by Razak Pharmaceuticals. Patients will take the pills daily and one hour before bedtime (along with their anticonvulsants) for 4 weeks. Intervention 2: Control group: In the control group, placebo with combination of tricalcium phosphate, magnesium stenarate and starch adhesive made by Razak Pharmaceuticals is also given with a similar shape, color and taste. Patients will take the pills daily and one hour before bedtime (along with their anticonvulsants) for 4 weeks. Yes - There is a plan to make this available What will be shared: Part of the data is shareable after people are unrecognizable When: starting from April 2020 To whom: People working in academic institutions Conditions: Anyone Where to obtain: Call Dr. Ali Abbaskhanian, Email: snali45@yahoo.com How to obtain: Send email Comments:
public Dr. Ali Abbaskhanian
Bouali hospital, Pasdaran Blv, Sari, Iran
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 2334 snali45@yahoo.com Mazandaran University of Medical Sciences scientific Dr. Ali Abbaskhanian
Bouali Hospital, Pasdaran Boulevard, Sari, Iran
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 2334 snali45@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Age 1 to 21 years with a history of seizure Seizure is not controlled with at least 3 different anticonvulsants At least four or more seizure episodes in last month 1 year 21 years Both Treatable seizure History of cardiovascular syndromes Neurodegenerative syndromes Hepatic and renal dysfunction History of pseudo seizure Blindness Irregular drug use Unreliable parents History of vasculitis Severe and persistent progressive seizure G40 Epilepsy and recurrent seizures Treatment - Drugs Placebo Intervention group: The intervention group will be prescribed melatonin tablet at a dose of 10 mg/m2 body surface area in the form of a 3 mg tablet manufactured by Razak Pharmaceuticals. Patients will take the pills daily and one hour before bedtime (along with their anticonvulsants) for 4 weeks. Control group: In the control group, placebo with combination of tricalcium phosphate, magnesium stenarate and starch adhesive made by Razak Pharmaceuticals is also given with a similar shape, color and taste. Patients will take the pills daily and one hour before bedtime (along with their anticonvulsants) for 4 weeks. Frequency and duration of seizure. Timepoint: Baseline (before intervention), first, second, third and fourth weeks. Method of measurement: Frequency and duration of seizure in day. Sleep quality. Timepoint: Baseline (before intervention), first, second, third and fourth weeks. Method of measurement: The Pittsburgh Sleep Quality Index (PSQI). Mazandaran University of Medical Sciences Approved 2019-07-02 Ethics committee of Mazandaran University of Medical Sciences Vice chancellor for research, Mazandaran University of Medical Sciences, Moallem Square, Sari, Iran Sari Mazandaran Iran (Islamic Republic of)