]>
IRCT20230419057960N1 IRCT 2023-10-08 Hamedan University of Medical Sciences Comparison the efficacy of Attentalin and Atomoxetin in ADHD Comparison of Attentalin and Atomoxetin in treatment of the attention deficit and hyper activity disorder 2023-11-11 anticipated 46 Complete https://irct.ir/trial/70092 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization : we use simple randomization and devided patient to two group A and B, Blinding description: Patients are divided into two groups, A and B. In one group, Attentalin syrup and placebo capsules are given, and in the other group, placebo syrup and Atomoxetine capsules are given.The patients has no knowledge about the other group, the drugs used and the placebo in the research are given to the patients by one of the clinic personnel with a specific code , so the researchers and the patient do not know the type of drug used. The data obtained from the study of the patients are collected by the researcher and are provided to the analyst and statistician in a private manner. 3 Attention deficit and hyperactivity disorder. Intervention 1: Intervention group A: The patient's weight, blood pressure and pulse are measured, physical symptoms and complaints are asked from the patient and parents. In this group, patients are treated with atomoxetine capsules with a starting dose of 0.5 mg per kilogram of weight, then after a week, the dose reaches 1 mg per kilogram of weight and the treatment continues. ADHD RATING SCALE questionnaire will be completed by the psychiatric resident on day zero and in week 3 and 6. Intervention 2: Intervention group B : The patient's weight, blood pressure and pulse are measured, physical symptoms and complaints are asked from the patient and parents. In this group, 23 patients are treated with Attentalin syrup with a starting dose of 5 cc/day then 10 cc/day after a week, . ADHD RATING SCALE questionnaire will be completed by the psychiatric resident on day zero and in week 3 and 6. 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 Ethical issues
public Atiyeh Majidi
Honarestan
Hamedan Iran (Islamic Republic of) 6516848741 +98 81 3827 9345 meytalaat@gmail.com Hamedan University of Medical Sciences scientific Helen Behmanesh
Honarestan
Hamedan Iran (Islamic Republic of) 6516848741 +98 81 3827 9344 Behmanesh.helen@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Patients who recieved Attentin Deficite and Hyoeractivity Disorder due to DSM 5 criteria . Obtaining Informed consent from parents Age 6 to 12 years old 6 years 12 years Both Seizures Glaucoma History of hyperthyroidism Eating disorders (anorexia) Children with a history of liver , kidney , heart diseases or other chronic illnesses requiring care Children who have taken MAOI medication for the 15 days prior to entering the study. substance abuse disorder F90 Attention-deficit hyperactivity disorders Treatment - Drugs Treatment - Drugs Intervention group A: The patient's weight, blood pressure and pulse are measured, physical symptoms and complaints are asked from the patient and parents. In this group, patients are treated with atomoxetine capsules with a starting dose of 0.5 mg per kilogram of weight, then after a week, the dose reaches 1 mg per kilogram of weight and the treatment continues. ADHD RATING SCALE questionnaire will be completed by the psychiatric resident on day zero and in week 3 and 6. Intervention group B : The patient's weight, blood pressure and pulse are measured, physical symptoms and complaints are asked from the patient and parents. In this group, 23 patients are treated with Attentalin syrup with a starting dose of 5 cc/day then 10 cc/day after a week, . ADHD RATING SCALE questionnaire will be completed by the psychiatric resident on day zero and in week 3 and 6. Symptoms of hyperactivity/attention deficit. Timepoint: before the trial and 3 and 6 weeks later. Method of measurement: ADHD Rating Scale. Hamedan University of Medical Sciences Approved 2023-03-11 Ethics committee of Hamedan University of Medical Science Kasshani Hamedan Hamadan Iran (Islamic Republic of)