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IRCT20190717044247N1 IRCT 2019-08-13 Ardabil University of Medical Sciences Evaluation of Atomoxetine on stuttering of children Evaluation of Atomoxetine on stuttering of children in 4-12 years old refering to neurological clinic in Ardabil 2019-09-23 anticipated 100 Complete https://irct.ir/trial/40901 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this project intervention group and placebo group will change to eradicate influence of speech therapy on results, Blinding description: Patients referred to the neurology clinic will be arranged in the order of referral in the intervention group with the main drug and placebo group. The medication will be prescribed for a period of three months. At the end of the three months, the group who received the original drug will be given a placebo and the placebo group will receive the original drug (atomoxetine). 3 Stuttering. Intervention 1: Intervention group: Including 50 patients who will be referred to the Pediatric Neurology Clinic for 2 months and randomly assigned to the Atomoxetine treatment group. This group will take the drug for 3 months. At the beginning and end of this three-month period, the stuttering severity assessment form will be completed. During the intervention, standard treatment, which is speech therapy, will be provided for all of these patients. Intervention 2: Control group: Including 50 patients who will be referred to the pediatric neurology clinic within 2 months and will be randomly assigned to a placebo treatment group. This group will use placebo for 3 months. At the beginning and end of this three-month period, the stuttering severity assessment form will be completed. During the intervention, standard treatment, which is speech therapy, will be provided for all of these patients. Intervention 3: Intervention group: This group includes the same 50 patients in control group 1 who will receive atomoxetine for another 3-month period. Standard stuttering (speech therapy) will also continue for this group. Intervention 4: Control group: This group includes the same 50 patients in intrvention group 1 who will receive placebo for another 3-month period. Standard stuttering (speech therapy) will also continue for this group. Yes - There is a plan to make this available What will be shared: The results of the study will include the efficacy of Atomoxtein on the severity of stuttering. The main characteristics of the patients, including their first name, will not be published. Other general specifications, including age and sex, and the extent to which they are communicated and their effect on stuttering, will be provided. When: Since the beginning of 1399 To whom: Academic or non-academic researchers Conditions: Using the results of the study with its source is allowed Where to obtain: Ardabil University of Medical Sciences at www.arums.ac.ir How to obtain: By accessing the site of Ardabil University of Medical Sciences, you can access the information of this research by selecting the library's digital library option. Comments:
public Akram Motamedi
Boali Pediatrics hospital, Varzesh square
Ardabil Iran (Islamic Republic of) 5613643197 +98 45 3325 2251 amot314@yahoo.com Ardabil University of Medical Sciences scientific Akram Motamedi
Stair 2, No 159, Golchin2 Ave, Shahrak Naderi, Ardabil
Ardabil Iran (Islamic Republic of) 5613643197 +98 45 3325 2251 amot314@yahoo.com Ardabil University of Medical Sciences Iran (Islamic Republic of) All 4 to 12 year-old patients with stuttering. 4 years 12 years Both Patients aged 12 to 4 years with stuttering with brain or evolutionary problems. Patients aged 4 to 12 years with stuttering do not go on a three-month follow-up to continue treatment. Patients aged 4 to 12 years with stutter, who are treated with a drug other than atomextin. F98.5 stuttering Treatment - Drugs Placebo Treatment - Drugs Placebo Intervention group: Including 50 patients who will be referred to the Pediatric Neurology Clinic for 2 months and randomly assigned to the Atomoxetine treatment group. This group will take the drug for 3 months. At the beginning and end of this three-month period, the stuttering severity assessment form will be completed. During the intervention, standard treatment, which is speech therapy, will be provided for all of these patients. Control group: Including 50 patients who will be referred to the pediatric neurology clinic within 2 months and will be randomly assigned to a placebo treatment group. This group will use placebo for 3 months. At the beginning and end of this three-month period, the stuttering severity assessment form will be completed. During the intervention, standard treatment, which is speech therapy, will be provided for all of these patients. Intervention group: This group includes the same 50 patients in control group 1 who will receive atomoxetine for another 3-month period. Standard stuttering (speech therapy) will also continue for this group. Control group: This group includes the same 50 patients in intrvention group 1 who will receive placebo for another 3-month period. Standard stuttering (speech therapy) will also continue for this group. Stuttering severity. Timepoint: Beginning of intervention and end of the 3 month period. Method of measurement: Severity Measurement Tool SSI4. Ardabil University of Medical Sciences Approved 2019-06-12 National Ethics Committee of Ardabil Medical Science University,National Ethics Committee for Biomed Boali pediatrics hospital, Varzesh square, Ardabil. Ardabil Ardabil Iran (Islamic Republic of)