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IRCT20211004052670N6 IRCT 2024-01-20 Esfahan University of Medical Sciences The Effectiveness of Probiotic Supplements in Attention Deficit-Hyperactivity Disorder The Effectiveness of Treatment with Probiotic Supplements Added to the Usual Treatment (Medical Treatment for Children with Parenting Training Sessions for Parents) in Children Suffering from Attention Deficit-Hyperactivity Disorder Referred to Specialized Treatment Centers for Child and Adolescent Psychiatry 2023-12-22 anticipated 80 Complete https://irct.ir/trial/71668 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 80 eligible patients are randomly selected. For this, the letter A written on 40 sheets, the letter B written on 40 sheets, and each of them is placed in an envelope. Each patients is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of two groups, Blinding description: In order to observe blindness, the drugs (medicine and placebo) are prepared in the same shape before the intervention and are coded and given to the physician. They prescribe them without knowing the type of each drug. Therefore, the patient,the person recording the clinical and baseline information of the patients as well as the statistical analyst will not be aware of the type of intervention. 3 Attention deficit-hyperactivity disorder. Intervention 1: Control groupThe control group was instructed to administer a capsule (contains placebo) once daily for a duration of 1.5 months concurrently with their routine medication. Drug utilization was communicated through a telephonic announcement, adhering to the guidelines provided by the pharmaceutical manufacturer (Amin Lab) and informed by extant research. Preceding the intervention, parent management training sessions were conducted for the participating parents. Intervention 2: Intervention group: The intervention group was instructed to administer a capsule (probiotics capsule 200 mg) once daily for a duration of 1.5 months concurrently with their routine medication. Drug utilization was communicated through a telephonic announcement, adhering to the guidelines provided by the pharmaceutical manufacturer (Amin Lab) and informed by extant research. Preceding the intervention, parent management training sessions were conducted for the participating parents. 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 Its Release Schedule Is Not Yet Known
public Afsaneh Karbasi Amel
No. 15, 2nd Floor, Kaj Blind Alley, Mehrdad Alley 3, 2nd Apadana Street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8166795471 +98 31 3641 1255 afsaneh_karbasi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Nazanin hoghoughi
No.37- Boustan 4, Emam Jafar Sadegh, Hezar Jerib Ave., Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174668671 +98 31 3673 4988 nazaninhoghoughi.94@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Children with Attention Deficit-Hyperactive Disorder with 6 to 12 years old. No change in treatment regimen during the last two months. Consent to participate in the study. 6 years 12 years Both Taking anti-depressant drugs, anti-psychotic drugs and mood stabilizers. Children with anxiety (based on Hamilton Rating Scale for Depression) and with depression (based on Children Depression Inventory). Children with Inflammatory Bowel Disease, Celiac disease and Irritable bowel syndrome. Children with Diabetes. F90.2 Attention-deficit hyperactivity disorder, combined type Placebo Treatment - Drugs Control groupThe control group was instructed to administer a capsule (contains placebo) once daily for a duration of 1.5 months concurrently with their routine medication. Drug utilization was communicated through a telephonic announcement, adhering to the guidelines provided by the pharmaceutical manufacturer (Amin Lab) and informed by extant research. Preceding the intervention, parent management training sessions were conducted for the participating parents. Intervention group: The intervention group was instructed to administer a capsule (probiotics capsule 200 mg) once daily for a duration of 1.5 months concurrently with their routine medication. Drug utilization was communicated through a telephonic announcement, adhering to the guidelines provided by the pharmaceutical manufacturer (Amin Lab) and informed by extant research. Preceding the intervention, parent management training sessions were conducted for the participating parents. Attention deficit-hyperactivity scale in attention deficit-hyperactivity rating scale. Timepoint: The questionnaire is filled in at the baseline visit and after 15 days of participating in parent training sessions (before the start of the intervention) and then 45 days later and after the end of taking the drug. Method of measurement: Attention deficit-hyperactivity rating scale. Attention deficit-hyperactivity scale in Connors questionnaire. Timepoint: The questionnaire is filled in at the baseline visit and after 15 days of participating in parent training sessions (before the start of the intervention) and then 45 days later and after the end of taking the drug. Method of measurement: Connors questionnaire. Quality of life score in Pediatric's Quality of Life Questionnaire. Timepoint: The questionnaire is filled in at the baseline visit and after 15 days of participating in parent training sessions (before the start of the intervention) and then 45 days later and after the end of taking the drug. Method of measurement: Pediatric's Quality of Life Questionnaire. Esfahan University of Medical Sciences Approved 2023-07-14 Ethical Committee of Isfahan University of Medical Sciences Ibn Sina Street, Amin Hospital, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)