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IRCT20090117001556N146 IRCT 2022-09-13 Tehran University of Medical Sciences Sulforaphane for the treatment of ADHD Sulforaphane as an adjuvant therapy in children with attention-deficit/hyperactivity disorder (ADHD): A randomized, double-blind, placebo-controlled clinical trial 2022-10-23 anticipated 50 Complete https://irct.ir/trial/65871 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 ADHD. Intervention 1: Control group: According to the patient's condition, the dose of Ritalin is 0.1 to 3.5 mg per kilogram of body weight + placebo daily for 8 weeks. Intervention 2: Intervention group: According to the patient's condition, the dose of Ritalin is 0.1 to 3.5 mg per kilogram of body weight + sulforaphane 30 mg/kg daily for 8 weeks. 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 2023 to 2028 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 Dr. 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 Dr. 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) Age between 6-11 years Diagnosis of ADHD based on DSM5 6 years 11 years Both Age range outside 6-11 years Diagnosis of a serious disease, or disease requiring surgery, or neurological diseases Diagnosis of a psychiatric disorder and taking neuropsychiatric drugs, except for ADD History of treatment with sulforaphane in the last three months History of treatment with neuroleptic medication in the last six months Weight less than 13.5 kg Mental retardation Seizure A systolic blood pressure greater than 125 or a resting heart rate less than 60 or greater than 115 History of allergy to sulforaphane or methylphenidate F90.2 Attention-deficit hyperactivity disorder, combined type Placebo Treatment - Drugs Control group: According to the patient's condition, the dose of Ritalin is 0.1 to 3.5 mg per kilogram of body weight + placebo daily for 8 weeks. Intervention group: According to the patient's condition, the dose of Ritalin is 0.1 to 3.5 mg per kilogram of body weight + sulforaphane 30 mg/kg daily for 8 weeks. Severity of ADHD. Timepoint: Weeks: 0 , 4 , 8. Method of measurement: By ADHD Rating Scale (by parents or teacher). Tehran University of Medical Sciences Approved 2022-06-20 Ethics Committee of School of Medicine, Tehran University of Medical Sciences Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)