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IRCT20090117001556N136 IRCT 2021-05-03 Tehran University of Medical Sciences L-Carnitine for the treatment of autism L-Carnitine as an adjuvant therapy in the treatment of autism in children: randomized double blind and placebo controlled clinical trial 2021-05-22 anticipated 50 Complete https://irct.ir/trial/55985 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization: using A and B blocks with n=4; AABB, ABAB, ABBA, BABA, BAAB, BBAA. We randomly use the blocks to achieve total sample size. ("A" and "B" are the study groups), Blinding description: The participants, care providers and outcome assessors will be blind regarding grouping. All the participants believe that they are taking the main medication (the participants who are taking placebo are not aware of it). Care providers and outcome assessors do not know which participants have received the main medication and which participants have received placebo. Thus, there is no orientation in their work process. 2-3 Autistic disorder. Intervention 1: Intervention group: Patients treated with risperidone 1-3mg per day and L-Carnitine 150mg/kg per day. Intervention 2: Control group: Patients treated with risperidone 1-3mg per day and placebo. Yes - There is a plan to make this available What will be shared: The data will be distributed through final report When: 5 years from 2022 to 2027 To whom: Academic researchers Conditions: Users should cite the resource of data Where to obtain: Prof Shahin Akhondzadeh How to obtain: by E mail Comments:
public Shahin Akhondzadeh
Roozbeh Hospital, South Kargar Street, Tehran
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 2222 s.akhond@sina.tums.ac.ir Tehran University of Medical Sciences scientific Prof. Shahin Akhondzadeh
Roozbeh Hospital, South Kargar Street, Tehran
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 2222 s.akhond@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) DSM-5 clinical diagnosis of autistic disorder Children between the ages of 5 and 11 years Having a minimum score of 12 in irritability 5 years 11 years Both Presence of any psychiatric disorder History of allergy to medications used in this research Presence of any active medical problem such as heart disease History of uncontrolled seizure Receiving any psychotropic medications except risperidone during past two weeks prior to the trial F84.0 Autistic disorder Treatment - Drugs Placebo Intervention group: Patients treated with risperidone 1-3mg per day and L-Carnitine 150mg/kg per day. Control group: Patients treated with risperidone 1-3mg per day and placebo. Severity of autism. Timepoint: Baseline and weeks 5, and 10. Method of measurement: By Aberrant Behavior Checklist-Community (ABC-C) and Childhood autism rating scale (CARS). Tehran University of Medical Sciences Approved 2020-11-30 Ethics Committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)