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IRCT20160530028182N9 IRCT 2022-12-01 Sanandaj University of Medical Sciences Effectiveness of etentalin, Ahura hyperactive and risperidone syrups in preschool children with attention deficit hyperactivity disorder Evaluation of the effectiveness of etentalin, Ahura hyperactive and risperidone syrups in preschool children with attention deficit hyperactivity disorder (ADHD) 2022-04-09 anticipated 57 Complete https://irct.ir/trial/62074 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block allocation method will be used for random allocation in this study. In this way, the patients who meet the criteria for entering the study are considered to be 3 and 4 years old or 5 and 6 years old, and based on the accident, the first person is 3 or 4 years old in one of the treatment groups and the second and third person is 3 or 4-year-old is placed in the second and third treatment groups, respectively, and also based on the accident, the first 5- or 6-year-old person is placed in one of the treatment groups, and the second and third 5- or 6-year-old person is placed in the second and third treatment groups, respectively. and this process will continue until the sample volume is completed, Blinding description: In this study, the patient does not know in which treatment group he has been placed, the patient's family also does not know in which treatment group he has been studied due to the fact that their patient receives standard treatment, and also the measurement subjects. The clinical outcome provider does not know how to categorize and how to group the studied subjects. Medicines are prepared and provided in coded packages that only the pharmacist is in the process of coding. 2 Attention Deficit Hyperactive Disorder(ADHD). Intervention 1: Intervention group: The patients included in the study during a period of 8 weeks are divided into three groups, the first group of Etentaline syrup (the first week 0.25 ml once a day, the second week 0.25 ml twice a day and after that If tolerated, 0.5 ml twice a day) is given. The patient will be visited at the beginning of the study (baseline), 2 weeks, 4 weeks, and 8 weeks later, and they will be checked for complications and reduction of symptoms, and the ADHD Rating Scale and CGI questionnaire will be completed. Intervention 2: Intervention group: Patients included in the study during a period of 8 weeks are divided into three groups, the second group is hyperactive syrup (first week 0.25 ml once a day, second week 0.25 ml twice a day and after that If tolerated, 0.5 ml twice a day) is given. The patient will be visited at the beginning of the study (baseline), 2 weeks, 4 weeks, and 8 weeks later, and they will be checked for complications and reduction of symptoms, and the ADHD Rating Scale and CGI questionnaire will be completed. Intervention 3: Intervention group: The patients included in the study during a period of 8 weeks are divided into three groups, the third group is Risperidone (0.25 ml once a day in the first week, 0.25 ml twice a day in the second week and then If tolerated, 0.5 ml twice a day) is given. The patient will be visited at the beginning of the study (baseline), 2 weeks, 4 weeks, and 8 weeks later, and they will be checked for complications and reduction of symptoms, and the ADHD Rating Scale and CGI questionnaire will be completed. Yes - There is a plan to make this available What will be shared: participant individual data When: 6 months after publication To whom: people working in academic institutions Conditions: researcher working on academic institution Where to obtain: dr.mohammadzadeh86@muk.ac.ir How to obtain: 2 month Comments:
public Soliman Mohammadzadeh
No. 1, Pasdaran Blvd.
Sanandaj Iran (Islamic Republic of) 6617978743 0098874957 Dr.mohammadzadeh86@muk.ac.ir Sanandaj University of Medical Sciences scientific Soliman Mohammadzadeh
No. 1, Pasdaran Blvd.
Sanandaj Iran (Islamic Republic of) 6617978743 +98 87 3366 4957 Dr.mohammadzadeh86@muk.ac.ir Sanandaj University of Medical Sciences Iran (Islamic Republic of) The age range of these children is 3 to 6 years According to the DSM-5 diagnostic criterion, the child and adolescent psychiatrist should diagnose ADHD in children. 3 years 6 years Both The presence of a serious physical illness, such as a seizure, based on parental history and clinical suspicion Existence of comorbid psychiatric disorder other than confrontational disobedience disorder Mental retardation based on clinical suspicion Taking medications for Attention Deficit Hyperactivity Disorder in the last month History of allergy to ethenalin and Ahura hyperactive F90.1 Attention-deficit hyperactivity disorder, predominantly hyperactive type Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: The patients included in the study during a period of 8 weeks are divided into three groups, the first group of Etentaline syrup (the first week 0.25 ml once a day, the second week 0.25 ml twice a day and after that If tolerated, 0.5 ml twice a day) is given. The patient will be visited at the beginning of the study (baseline), 2 weeks, 4 weeks, and 8 weeks later, and they will be checked for complications and reduction of symptoms, and the ADHD Rating Scale and CGI questionnaire will be completed. Intervention group: Patients included in the study during a period of 8 weeks are divided into three groups, the second group is hyperactive syrup (first week 0.25 ml once a day, second week 0.25 ml twice a day and after that If tolerated, 0.5 ml twice a day) is given. The patient will be visited at the beginning of the study (baseline), 2 weeks, 4 weeks, and 8 weeks later, and they will be checked for complications and reduction of symptoms, and the ADHD Rating Scale and CGI questionnaire will be completed. Intervention group: The patients included in the study during a period of 8 weeks are divided into three groups, the third group is Risperidone (0.25 ml once a day in the first week, 0.25 ml twice a day in the second week and then If tolerated, 0.5 ml twice a day) is given. The patient will be visited at the beginning of the study (baseline), 2 weeks, 4 weeks, and 8 weeks later, and they will be checked for complications and reduction of symptoms, and the ADHD Rating Scale and CGI questionnaire will be completed. Parent’s ADHD Rating scale Number. Timepoint: At the beginning of the study (baseline), 2 weeks, 4 weeks and 8 weeks after the study. Method of measurement: Parent’s ADHD Rating scale. Clinical Global Impressions Number. Timepoint: At the beginning of the study (baseline), 2 weeks, 4 weeks and 8 weeks after the study. Method of measurement: Clinical Global Impressions. Sanandaj University of Medical Sciences Approved 2021-12-28 Ethics Committee of Kurdistan University of Medical Sciences Pasdaran Sanandaj Kurdistan Iran (Islamic Republic of)