Investigating the effect of Attentalin on the severity of symptoms of hyperactivity/impulsivity in children with hyperactivity attention deficit disorder

Determining the effect of atentalin on the severity of symptoms of hyperactivity-impulsivity in patients with attention deficit hyperactivity disorder

This clinical trial has a control group, on children 6 to 9 years old with ADHD disorder, with parallel groups, double-blind, randomized, phase 3 on 108 patients. Randomization was done by block randomization method.

This clinical trial of the control group will be conducted on children aged 6 to 9 years with ADHD at the Children's Psychiatry Clinic of Amirkabir arak Hospital.The study is double-blind and the researcher and the patient are blinded. In both groups, Methylphenidate 5 mg once or twice We start in the day, and in the intervention group, Attentalin syrup (10 cc twice a day) and in the control group, placebo syrup (at the rate of 10 cc twice a day) will be used for 8 weeks. Evaluation of the severity of ADHD symptoms using Connors questionnaire of parents is done. Connors questionnaire and checklist of demographic and confounding factors are completed by the patient's parents in the first session of the visit, also 8 weeks later Connors questionnaire and medication side effects checklist are completed by them.

Inclusion criteria:Patients with(ADHD),Informed consent of the patient's parents or legal guardian to participate in the study. Exclusion criteria:Failure to comply with the prescribed medication dosage

Group 1: Methylphenidate 5 mg once or twice a day and Attentalin syrup (10 cc twice a day). Group 2: Methylphenidate 5 mg once or twice a day and placebo syrup (in the amount of 10 cc)

Severity of symptoms of hyperactivity/impulsivity

All patients who meet the inclusion criteria are divided into two groups A (intervention) and B (control) using block randomization method using blocks of four. In order to use block randomization, blocks of four are used, which will have 6 blocks in the following order, and one of the blocks is numbered and will be used for 4 patients, that is, if block number 1 is selected in the lottery, the first patient Treatment A, the second patient will receive treatment B, the third patient will receive treatment A, and the fourth patient will receive treatment B. The fifth patient will be randomly selected from one of the blocks and the type of treatment will be assigned to the fifth to eighth patients according to the block. In the block randomization method, a block may be selected more than once in the lottery. In this way, two equal groups of 54 patients are placed in 27 blocks of 4. 1-ABAB 2-AABB 3- ABBA 4- BAAB 5-BBAA 6-BABA

This study will be double-blind, considering that both groups receive the drug in the form of oral syrup and the method of administration is the same for both groups, the patients will not know what treatment they are receiving. Also, in order to divide the patients. An envelope was used to group the patients based on the letters A (intervention group) and B (placebo group), and based on this, the patient and the doctor were blinded to the patient group. After obtaining the consent of the legal guardian, the patient entered the study. And the medicine is given to the patients by the neurologist. Based on this, the patients and the psychiatric assistant are blind to the type of medicine and the group of patients, but the neurologist who gives the medicine to the patients is aware of the type of medicine.

All data except the identification information of the studied subjects can be published.

since 2025

Medical students

Scientific and therapeutic use is unimpeded

You can contact Dr. Tayyaba Shuja located in Amirkabir Arak Hospital with mobile number 09102042372, email T.shuja@arakmu.ac.ir.

The applicant can make her request through the given email or phone call, after 3 months of the application, the result will be notified to the applicant and the approved items will be sent to the applicant.