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IRCT20230607058407N1 IRCT 2023-10-30 Shahid Beheshti University of Medical Sciences Evaliuation of the effect of Melatonin and Agomelatin on sleep problem in children and adolescent with Autism spactrum disorder ملاتونین بر خواب اوتیسم Evaliuation of the effect of Melatonin and Agomelatin on sleep problem in children and adolescent with Autism spactrum disorder 2023-07-11 anticipated 80 Complete https://irct.ir/trial/70547 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: ASD severity will assessed and depression ,anxiety and ADHD will R/O, Randomization description: Randomization: All eligible subjects will be randomly assigned to one of the two groups receiving melathionine and agomelatine with a ratio of 1:1. The randomization method will be permuted block randomization, which blocks will be done based on the sample size in sizes 2, 4, 6, 8 until the sample size is exhausted using the website https://icostatistics.shinyapps.io/randlist/. Patients will be included in each group based on the determined sample size and based on the list of randomized individuals (along with a specific research code for each individual), Blinding description: In compliance with health principles,the melatonin and agomelatonin tablets will be removed from the original drug envelope by the clinic secretary and will be given to the parents in the nameless envelope according to the randomization table. With this method, the patient, parent, researcher and statistician do not know the type of medicine used by each patient. 3 Condition 1: Autism spectrum disorder. Condition 2: sleep disorder. Intervention 1: Control group: slow-release melatonin tab: half a tablet of 3 mg for the age of 3-5 years, one tablet of 3 mg for the age of 6-12, and melatonin 5mg for the age of 12-18, half an hour before bedtime. Intervention 2: Intervention group: Agumelatine tab imediate release 25 mg ,one tablet at night ,half an hour before sleep. Yes - There is a plan to make this available What will be shared: The results of the data analysis will be published in the form of an article When: After publication in domestic or foreign magazines To whom: no body Conditions: --- Where to obtain: -- How to obtain: -- Comments:
public Nezhla Mostafeenezhad
Madani st, Imam Hosein Hospital
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7755 1023 Dr.nejla.mostafeenezhad@gmail.com Shahid Beheshti University of Medical Sciences scientific Dr Nezhla Mostafeenezhad
Madani st, Imamhosein Hospital, Child and Adolescents Psychiatry Ward
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7755 1023 Dr.nejla.mostafeenezhad@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) children and adolescents with autism spectrum disorder and with sleep disorders 3 years 18 years Both doubt to sleep apnea resistant patiants F84.0 G47.0 Autistic disorder Insomnia Treatment - Drugs Treatment - Drugs Control group: slow-release melatonin tab: half a tablet of 3 mg for the age of 3-5 years, one tablet of 3 mg for the age of 6-12, and melatonin 5mg for the age of 12-18, half an hour before bedtime Intervention group: Agumelatine tab imediate release 25 mg ,one tablet at night ,half an hour before sleep Change the score of children sleep habits questannaire. Timepoint: at the beggining and 1 month later. Method of measurement: children sleep habits questannaire. Shahid Beheshti University of Medical Sciences Approved 2023-06-03 Ethicscimmittee of Shahid Beheshti University of Medical Sciences Shahid Beheshti university of medical science,Medical school, velenjak, Koodakyar Avn, DaneshjooAvn,Tehran Tehran Tehran Iran (Islamic Republic of)