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IRCT20160530028182N10 IRCT 2023-09-20 Sanandaj University of Medical Sciences Effectiveness of Ritalin, Stimedit and Practisa in primary school children with attention deficit hyperactivity disorder Comparison of the effectiveness of Ritalin, Stimdate and Practisa in primary school children with Attention Deficit Hyperactivity Disorder 2023-06-22 anticipated 60 Complete https://irct.ir/trial/67422 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, according to age, patients are categorized into two age groups: 6-8 years old and 9-11 years old. Then the patients have criteria for entering the study based on whether they are in the group of 6-8 years old or the group of 9-11 years old and based on coincidence, the first person aged 6-8 years old is in one of the treatment groups and the second and third person aged 6-8 years old respectively in The second and third groups of treatment are placed, and also based on the coincidence, the first person aged 9-11 is placed in one of the treatment groups, and the second and third person, 9-11 years old, are placed in the second and third treatment groups, respectively, and this process continues until completion. The sample size will continue. How to group, allocate and blind: In order for the study to be double-blind, the researcher randomly divides the subjects into groups 1, 2, and 3, and they are referred to the person responsible for the treatment (pharmacy) with such a code. Ritalin, Stimedit and Practisa are placed in the same capsules and are given to patients by the pharmacy in pre-prepared envelopes according to codes 1, 2 and 3. The therapeutic dose of methylphenidate tablets 10 mg manufactured by Novartis company for the first week (daily, one quarter in the morning and one quarter in the evening), the second week (daily, one half in the morning and one half in the evening) and the third week onwards based on the patient's tolerance (daily , one in the morning and one in the evening) is recommended. It should be noted that it will be done in the same way in each age group, 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 Hyperactivity Disorder. Intervention 1: Intervention group: The patients included in the study during a period of 8 weeks are divided into three groups. The first group is Iranian methylphenidate (stimulant) 10 mg manufactured by Mehr Daru company for the first week (daily, one quarter in the morning and one quarter in the evening), the second week ( daily, one half in the morning and one half in the evening) and the third week onwards based on the patient's tolerance (daily, one in the morning and one in the evening) is prescribed. 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: The patients included in the study during a period of 8 weeks are divided into three groups. The second group is Iranian methylphenidate (Practisa) 10 mg manufactured by Vana Daru Gostar company for the first week (daily, one quarter in the morning and one quarter in the evening), the second week ( daily, one half in the morning and one half in the evening) and the third week onwards based on the patient's tolerance (daily, one in the morning and one in the evening) is prescribed. 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 Ritalin 10 mg manufactured by Novartis for the first week (daily, a quarter in the morning and a quarter in the evening), the second week (daily, a quarter in the morning and a quarter in the evening). one second in the evening) and the third week onwards based on the patient's tolerance (daily, one in the morning and one in the evening) is prescribed. It will be 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: Individual data of participants When: 6 months after the results are published To whom: People working in academic institutions Conditions: Researchers in this field 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 +98 87 3366 4957 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 of these children is 6 to 12. Based on the diagnostic criteria of DSM-5, the child and adolescent psychiatry specialist should diagnose attention deficit hyperactivity disorder in children. 6 years 12 years Both Existence of serious physical disease such as seizure disease, heart disease based on parents' history and clinical suspicion Presence of accompanying psychiatric disorder Mental retardation based on clinical suspicion Taking drugs for attention deficit hyperactivity disorder in the last month F90.0 Attention-deficit hyperactivity disorder, predominantly inattentive 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 is Iranian methylphenidate (stimulant) 10 mg manufactured by Mehr Daru company for the first week (daily, one quarter in the morning and one quarter in the evening), the second week ( daily, one half in the morning and one half in the evening) and the third week onwards based on the patient's tolerance (daily, one in the morning and one in the evening) is prescribed. 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 second group is Iranian methylphenidate (Practisa) 10 mg manufactured by Vana Daru Gostar company for the first week (daily, one quarter in the morning and one quarter in the evening), the second week ( daily, one half in the morning and one half in the evening) and the third week onwards based on the patient's tolerance (daily, one in the morning and one in the evening) is prescribed. 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 Ritalin 10 mg manufactured by Novartis for the first week (daily, a quarter in the morning and a quarter in the evening), the second week (daily, a quarter in the morning and a quarter in the evening). one second in the evening) and the third week onwards based on the patient's tolerance (daily, one in the morning and one in the evening) is prescribed. It will be 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. Clinical Global Impressions Number. Timepoint: The beginning of the study (basic), 2 weeks, 4 weeks and 8 weeks after the study. Method of measurement: Clinical Global Impressions. Sanandaj University of Medical Sciences Approved 2022-11-08 Ethics Committee of Kurdistan University of Medical Sciences No. 1, Pasdaran Blvd. Sanandaj Town Sanandaj Kurdistan Iran (Islamic Republic of)