Comparison of the effect of citicoline on the cognitive and behavioral performance of autism spectrum patients referred to Imam Reza Clinic in Shiraz with standard treatments.
Design
The statistical population includes all child patients (less than 18 years old) suffering from autism spectrum disorders who refer to Imam Reza Clinic in Shiraz. The control group of children with autism who receive standard treatments including the neuroleptic drug Risperidone, Piracetam and Omega 3, and the second group receives citicoline drug in addition to the neuroleptic drug.considering, the number of 37 people for each group was determined as the sample size. became.Finally, considering a 10% drop, at least 41 people were considered for each group.Due to the fact that the population of autistic patients refer to Imam Reza clinic therefore, the census method is used to determine the sample size.
Settings and conduct
All patients will be examined by pediatric neurologists, and patient information including demographic information and findings related to the progress or treatment of autism spectrum disorder will be collected in special forms.
Participants/Inclusion and exclusion criteria
The statistical includes all child patients (less than 18 years old) suffering from autism spectrum disorders who refer to Imam Reza Clinic in shiraz
Inclusion criteria:
Primary diagnosis of autism using MCHAT test in children under 3 years old and CARS test in children over 3 years old.
Exclusion criteria:
Intractable seizures, high blood pressure, underlying diseases such as diabetes and asthma, and lack of parental consent to enter the study.
Intervention groups
Intramuscular injection of citicoline drug in the form of 10 mg/kg twice a week for one month and after one month of drug injection, initial tests are completed by the patient.
Main outcome variables
Finding a new drug to treat autism
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231030059898N1
Registration date:2023-11-08, 1402/08/17
Registration timing:prospective
Last update:2023-11-08, 1402/08/17
Update count:0
Registration date
2023-11-08, 1402/08/17
Registrant information
Name
Samaneh Zare
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4298
Email address
stud2500025152@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-11, 1402/08/20
Expected recruitment end date
2024-01-11, 1402/10/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Citicoline on the cognitive-behavioral performance of autism spectrum patients with standard treatments
Public title
Comparison of the effect of Citicoline on the cognitive-behavioral performance of autism spectrum patients with standard treatments
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primary diagnosis of autism using MCHAT test in children under 3 years old and CARS test in children over 3 years old
Exclusion criteria:
Intractable seizures, high blood pressure, underlying diseases such as diabetes and asthma, and lack of parental consent to enter the study
Age
To 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation method in this study will be the random permutation block method of 4 such that A represents a person who receives standard treatments and citicoline and B represents a person who receives only standard treatments. This method considering blocks of six so that the total number of possible permutations of six is equal to 6 includes: ABAB, BABA, AABB, BBAA and ABBA, BAAB. Then, by using the table of random numbers and assigning a code from 0 to 9 to each of the permutations, the desired random list of 80 items, which includes 20 blocks of 4 items (4 x 20 = 80 total number of samples) is generated and the order of allocation Each of the methods is specified for each of the samples participating in the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The specialized committee of ethics in biomedical research
Street address
central building of Shiraz University of Medical Sciences, in front of Palestine Street, Zand Street, Shiraz
City
shiraz
Province
Fars
Postal code
71348-14336
Approval date
2023-10-16, 1402/07/24
Ethics committee reference number
IR.SUMS.MED.REC.1402.325
Health conditions studied
1
Description of health condition studied
Autism spectrum disorder
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
MCHAT test score for under 3 years old and CARS test for over 3 years old
Timepoint
The beginning of the study and 2 months later
Method of measurement
MCHAT test for under 3 years old and CARS test for over 3 years old
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intramuscular injection of citicoline along with standard treatments to 40 people under the age of 18 with autism.
Category
Treatment - Drugs
2
Description
Control group: receiving standard treatments by 40 patients with autism
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza specialized and sub specialized clinic
Full name of responsible person
Razieh Taghizade Sarvestani
Street address
Namazi Sq, Shiraz
City
Shiraz
Province
Fars
Postal code
71348-14734
Phone
+98 71 3212 7000
Email
motahari@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempour
Street address
Shiraz, Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Razieh Taghizade Sarvestani
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
namazi sq-namazi hospital
City
shiraz
Province
Fars
Postal code
71936-13311
Phone
+98 71 3647 4332
Email
zare.samane68@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Razieh Taghizade Sarvestani
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Namazi Sq-Namazi hospital
City
Shiraz
Province
Fars
Postal code
۱۳۳۱۱ – ۷۱۹۳۶
Phone
+98 71 3647 4332
Email
zare.samane68@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Razieh Taghizade Sarvestani
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Namazi Sq, Namazi Hospital
City
Shiraz
Province
Fars
Postal code
۱۳۳۱۱ – ۷۱۹۳۶
Phone
+98 71 3647 4332
Email
zare.samane68@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available