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IRCT20230718058834N1 IRCT 2023-11-21 Shahre-kord University of Medical Sciences Effect of Neurosed syrup on ADHD ‏ Evaluation of therapeutic effects of Neurosed syrup on the clinical symptoms of children with ADHD -A randomized double blind trial 2023-12-01 anticipated 50 Complete https://irct.ir/trial/73372 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be gradually included in the study according to the available method and will be assigned to two intervention and control groups based on the random allocation method. For this purpose, we place 50 cards with the letter A on 25 of them and the letter B on the other 25 in an envelope and randomly take out one card for each patient. The word that comes out shows the group of the patient, Blinding description: In order to blind the patients, Norosed syrup and placebo are prepared from the same company and in the same packaging. The doctor conducting the trial and the patient do not know the content of the original syrups and placebo until the end of the study and extracting the results, so the study is double-blind. 3 Attention Deficit Hyperactivity Disorder (ADHD). Intervention 1: Intervention group: A number of 25 children aged 5-12 years with ADHD referred to Imam Ali Shahrekord clinic, who will use Neurosed syrup, which contains Melissa Officinalis extract and vitamins B and C, once a day for a month.This syrup is produced by Touba Faraz Pars company. Before and after the intervention, the symptoms related to ADHD disorder in these patients are examined using the Conners parents' questionnaire. Intervention 2: Control group: A number of 25 children aged 5-12 with ADHD referring to Imam Ali Shahrekord clinic who will use placebo syrup once a day for one month. This syrup is produced by Touba Faraz Pars Company and it is not different from the original syrup in terms of appearance but it does not contain the active ingredient. Before and after the intervention, the symptoms related to ADHD disorder in these patients are examined using the Conners parents' questionnaire. Yes - There is a plan to make this available What will be shared: To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy will be published. When: The access period will start 6 months after the results are published. To whom: Our data will only be available to researchers working in academic and scientific institutions. Conditions: Except for personal information about people, all of our data will be shared if certain requirements are met. Our data will only be used for comparable study and peer review by other researchers. Anyone working in universities or scientific institutions who wants to do similar study or confirm the accuracy of our data can access our data. Where to obtain: All qualified individuals can collect data by referring to the project manager in order to acquire information. Contact information is available via email at torabimaryam75@gmail.com or the contact number 00989138653570. How to obtain: To receive information after sending the request, the requests will be reviewed within 10 days. If the above conditions are met, the information will be sent to the provided email within 30 days at most. Comments:
public Maryam Torabi
Kashani Street, Shahrekord, Chaharmahal va Bakhtiary, Iran
Shahre-Kord Iran (Islamic Republic of) 8816754633 038322220016 torabimaryam75@gmail.com Shahre-kord University of Medical Sciences scientific Elham Zarean
Kashani Street, Shahrekord, Chaharmahal va Bakhtiary, Iran
Shahre-Kord Iran (Islamic Republic of) 8816754633 +98 38 3222 0016 e.zarean@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Children with ADHD The age of people should be 5-12 years 5 years 12 years Both Use of Barbiturates, drugs that suppress the central nervous system, and blood sugar-lowering drugs Presence of other concurrent diseases F90.0 Attention-deficit hyperactivity disorder, predominantly inattentive type Treatment - Drugs Placebo Intervention group: A number of 25 children aged 5-12 years with ADHD referred to Imam Ali Shahrekord clinic, who will use Neurosed syrup, which contains Melissa Officinalis extract and vitamins B and C, once a day for a month.This syrup is produced by Touba Faraz Pars company. Before and after the intervention, the symptoms related to ADHD disorder in these patients are examined using the Conners parents' questionnaire. Control group: A number of 25 children aged 5-12 with ADHD referring to Imam Ali Shahrekord clinic who will use placebo syrup once a day for one month. This syrup is produced by Touba Faraz Pars Company and it is not different from the original syrup in terms of appearance but it does not contain the active ingredient. Before and after the intervention, the symptoms related to ADHD disorder in these patients are examined using the Conners parents' questionnaire. ADHD score according to Conners parent questionnaire. Timepoint: Before the start of the intervention and one month after consuming Neurosed syrup. Method of measurement: Conners parent questionnaire. Shahre-kord University of Medical Sciences Approved 2023-06-10 Ethics Committee of the School of Medicine, Shahrekord University of Medical Sciences Headquarters of Shahrekord University of Medical Sciences,Kashani Street, Shahrekord, Chaharmahal va Bakhtiary, Iran Shahr-e Kord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)