Evaluation of the effectiveness of etentalin, Ahura hyperactive and risperidone syrups in preschool children with attention deficit hyperactivity disorder (ADHD)
Efficacy of etentalin, Ahura hyperactive and risperidone syrups in preschool children with attention deficit / hyperactivity disorder
Design
Clinical trial, double-blind, randomized, phase 2 on 57 patients, block allocation method was used for randomization.
Settings and conduct
The study is carried out on children suffering from attention deficit hyperactivity disorder who refer to the Ba'ath Hospital clinic in Sanandaj.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 3 to 6 years of age, Attention Deficit Hyperactivity Disorder. Exclusion criteria: Existence of physical illness, Existence of comorbid psychiatric disorder, Mental retardation, Taking drugs for ADHD, History of drug allergy
Intervention groups
The intervention in this study is ethentalin, Ahura hyperactive and risperidone syrups. The first week 0.25 ml once a day, the second week 0.25 ml twice a day and then if tolerated 0.5 ml twice a day
More about this source text
Main outcome variables
The person's score is based on Parent's ADHD Rating scale and CGI (Clinical Global Impressions) questionnaires.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160530028182N9
Registration date:2022-12-01, 1401/09/10
Registration timing:registered_while_recruiting
Last update:2022-12-01, 1401/09/10
Update count:0
Registration date
2022-12-01, 1401/09/10
Registrant information
Name
Soleiman Mohammadzadeh
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3323 2168
Email address
dr.mohammadzadeh86@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-09, 1401/01/20
Expected recruitment end date
2023-01-10, 1401/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of etentalin, Ahura hyperactive and risperidone syrups in preschool children with attention deficit hyperactivity disorder (ADHD)
Public title
Effectiveness of etentalin, Ahura hyperactive and risperidone syrups in preschool children with attention deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age range of these children is 3 to 6 years
According to the DSM-5 diagnostic criterion, the child and adolescent psychiatrist should diagnose ADHD in children.
Exclusion criteria:
The presence of a serious physical illness, such as a seizure, based on parental history and clinical suspicion
Existence of comorbid psychiatric disorder other than confrontational disobedience disorder
Mental retardation based on clinical suspicion
Taking medications for Attention Deficit Hyperactivity Disorder in the last month
History of allergy to ethenalin and Ahura hyperactive
Age
From 3 years old to 6 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
57
Randomization (investigator's opinion)
Randomized
Randomization description
Block allocation method will be used for random allocation in this study. In this way, the patients who meet the criteria for entering the study are considered to be 3 and 4 years old or 5 and 6 years old, and based on the accident, the first person is 3 or 4 years old in one of the treatment groups and the second and third person is 3 or 4-year-old is placed in the second and third treatment groups, respectively, and also based on the accident, the first 5- or 6-year-old person is placed in one of the treatment groups, and the second and third 5- or 6-year-old person is placed in the second and third treatment groups, respectively. and this process will continue until the sample volume is completed.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patient does not know in which treatment group he has been placed, the patient's family also does not know in which treatment group he has been studied due to the fact that their patient receives standard treatment, and also the measurement subjects. The clinical outcome provider does not know how to categorize and how to group the studied subjects. Medicines are prepared and provided in coded packages that only the pharmacist is in the process of coding.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University of Medical Sciences
Street address
Pasdaran
City
Sanandaj
Province
Kurdistan
Postal code
6617913141
Approval date
2021-12-28, 1400/10/07
Ethics committee reference number
IR.MUK.REC.1400.250
Health conditions studied
1
Description of health condition studied
Attention Deficit Hyperactive Disorder(ADHD)
ICD-10 code
F90.1
ICD-10 code description
Attention-deficit hyperactivity disorder, predominantly hyperactive type
Primary outcomes
1
Description
Parent’s ADHD Rating scale Number
Timepoint
At the beginning of the study (baseline), 2 weeks, 4 weeks and 8 weeks after the study
Method of measurement
Parent’s ADHD Rating scale
2
Description
Clinical Global Impressions Number
Timepoint
At the beginning of the study (baseline), 2 weeks, 4 weeks and 8 weeks after the study
Method of measurement
Clinical Global Impressions
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patients included in the study during a period of 8 weeks are divided into three groups, the first group of Etentaline syrup (the first week 0.25 ml once a day, the second week 0.25 ml twice a day and after that If tolerated, 0.5 ml twice a day) is given. The patient will be visited at the beginning of the study (baseline), 2 weeks, 4 weeks, and 8 weeks later, and they will be checked for complications and reduction of symptoms, and the ADHD Rating Scale and CGI questionnaire will be completed.
Category
Treatment - Drugs
2
Description
Intervention group: Patients included in the study during a period of 8 weeks are divided into three groups, the second group is hyperactive syrup (first week 0.25 ml once a day, second week 0.25 ml twice a day and after that If tolerated, 0.5 ml twice a day) is given. The patient will be visited at the beginning of the study (baseline), 2 weeks, 4 weeks, and 8 weeks later, and they will be checked for complications and reduction of symptoms, and the ADHD Rating Scale and CGI questionnaire will be completed.
Category
Treatment - Drugs
3
Description
Intervention group: The patients included in the study during a period of 8 weeks are divided into three groups, the third group is Risperidone (0.25 ml once a day in the first week, 0.25 ml twice a day in the second week and then If tolerated, 0.5 ml twice a day) is given. The patient will be visited at the beginning of the study (baseline), 2 weeks, 4 weeks, and 8 weeks later, and they will be checked for complications and reduction of symptoms, and the ADHD Rating Scale and CGI questionnaire will be completed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Quds Hospital Sanandaj
Full name of responsible person
Soliman Mohammadzadeh
Street address
Entezam Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617113141
Phone
+98 87 3366 0025
Email
dr.mohammadzadeh86@muk.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Malaki
Street address
Pasdaran Blv.
City
sanandaj
Province
Kurdistan
Postal code
6617978743
Phone
+98 87 3366 4957
Email
dr.mohammadzadeh86@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Soliman Mohammadzadeh
Position
Associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
No. 1, Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
6617978743
Phone
0098874957
Email
Dr.mohammadzadeh86@muk.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Soliman Mohammadzadeh
Position
Associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
No. 1, Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
6617978743
Phone
+98 87 3366 4957
Email
Dr.mohammadzadeh86@muk.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Soliman Mohammadzadeh
Position
Associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617978743
Phone
+98 87 3366 4957
Email
dr.mohammadzadeh86@muk.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
participant individual data
When the data will become available and for how long
6 months after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
researcher working on academic institution
From where data/document is obtainable
dr.mohammadzadeh86@muk.ac.ir
What processes are involved for a request to access data/document