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IRCT20181022041407N1 IRCT 2018-11-02 Mashhad University of Medical Sciences evaluation the effect of probiotic on treatment of ADHD children Evaluation of the effectiveness of probiotic on the treatment of ADHD children 2020-03-20 anticipated 60 Complete https://irct.ir/trial/34659 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple Randomization Randomization Method: excel software or other randomization websites Allocation Concealment: opaque envelope, Blinding description: After the description about the method and aim of the study and informed consents of parents, randomization will be done. The type of treatment is written with odds and even number in separate papers and placed in an opaque envelope. After the psychiatrist visits the patients, if the patients have the inclusion criteria, the method of the study will describe to the parents. If they agree to participate in this study, the informed consent form must be completed. Then the psychiatrist will take an envelope and write the patients characteristic with the special number(odds or even) in the list. So, patients and psychiatrist only know the number (not the intervention or control group). After the special time, the assessor evaluates the children with the specific questionnaire. He does not know which group the patient is (blind). Then the complete data will b presented to the analyzer for data analysis. In the datasheet the group will type as odd/even numbers(not the group names), so the analyzer is blind too. N/A ADHD. Intervention 1: Intervention group: ADHD treatment + probiotic. Intervention 2: Control group: ADHD treatment + placebo. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Because of long duration of industrial phase of the study, I have not decided yet.
public Maryam Emadzadeh
Department of Community Medicine, Faculty of Medicine, University Campus, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3882 9262 maryamemadzadeh@yahoo.com Mashhad University of Medical Sciences scientific Maryam Emadzadeh
Department of Community Medicine, Faculty of Medicine, University Campus, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3882 9262 maryamemadzadeh@yahoo.com Mashhad University of Medical Sciences Iran (Islamic Republic of) 4-16 year old children New case of ADHD diagnosed by psychiatrist 4 years 16 years Both History of treatment because of ADHD in the last 2 months Other psychological problems Mental Retardation F90.9 Attention-deficit hyperactivity disorder, unspecified type Treatment - Drugs Placebo Intervention group: ADHD treatment + probiotic Control group: ADHD treatment + placebo Evaluation of ADHD scale with Conner’s parent rating scale. Timepoint: Baseline, 4 and 8 weeks after the first visit. Method of measurement: Conner’s parent rating scale. Integrated Visual and Auditory Continues Performance Test (IVA/CPT). Timepoint: Baseline and after 8 weeks. Method of measurement: A computerized standardized test consists of both auditory and visual parts. Research Institute of Food Science and Technology Mashhad University of Medical Sciences Research Institute of Food Science and Technology Approved 2018-09-05 Institutional Research Ethics Committee, School of Medicine- Mashhad University of Medical Sciences Azadi Square, University Campus, Faculty of Medicine Mashhad Razavi Khorasan Iran (Islamic Republic of)