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IRCT20110628006907N16 IRCT 2022-01-07 Tehran University of Medical Sciences The effect of Cinnarizine on Autism Interventional comparison of the effect of cinnarizine with placebo on mood swings and self-harm and stereotyped behaviors of autistic patients 2022-01-20 anticipated 34 Complete https://irct.ir/trial/60891 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individual simple randomization 34 3-letter codes are generated using www.randomcodegenerator and then half of these codes is assigned to "intervention group" and the other half to "control group". Cinarrizine or placebo (pills are completely identical) are put into identical pockets based on the codes tagged on them. Then the pockets are mixed up. Each patient will recieve a pocket with a code on it which neither researcher or patient don't know whether it belongs to intervention or control group, Blinding description: first, 34 3-letter codes will be randomly generated. Each code will be randomly assigned to either control or intervention group. Cinnarizine or placebo pills are put into completely identical pockets and 3-letter codes are written on them. pockets will be mix up. patients or researcher won't know the whether the pocket contains cinnarizine or placebo. 3 autism spectrum disorder. Intervention 1: Intervention group (17 patients): Receiving Cinnarizine 10-15 mg/kg once daily for 3 months. Intervention 2: Control group (17 patients): Receiving placebo 10-15 mg/kg once daily for 3 months. Yes - There is a plan to make this available What will be shared: All collected data about primary and secondary outcomes When: After the publication of the paper To whom: people working in academic institutions Conditions: Data can be used if the authors’ names were mentioned Where to obtain: Email How to obtain: After receiving the request we will consult with all authors and the data can be shared in a week Comments:
public Mahmoudreza Ashrafi
Gharib Street, Children's Medical Center
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6612 9252 ashrafim@tums.ac.ir Tehran University of Medical Sciences scientific Mahmoudreza Ashrafi
Gharib Street, Children's Medical Center
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6612 9252 ashrafim@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age between 2-7 years old Diagnosed with Autism based on DSM5 criteria which is approved by a psychiatrist 2 years 7 years Both Conditions other than Autism justifying the symptoms of patient F84.0 Autistic disorder Treatment - Drugs Placebo Intervention group (17 patients): Receiving Cinnarizine 10-15 mg/kg once daily for 3 months Control group (17 patients): Receiving placebo 10-15 mg/kg once daily for 3 months Patient's score from the Behavioral problems questionnaire for people with intellectual disabilities. Timepoint: at the beginning of trial and 3 months later. Method of measurement: Behavioral problems questionnaire for people with intellectual disabilities. Tehran University of Medical Sciences Approved 2021-12-26 Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences Building no.1, Northern gate of the university, Poursina St. Qods St. Enqelab St. Tehran Tehran Iran (Islamic Republic of)