Objective :
Determination of Cerebrolysin effects on cognitive and verbal aspects of children suffering from autism spectrum disorder
Design:
Thirty six children ranging in age from 3 to 10 year-old children suffering from Autism spectrum disorder referred to pediatric neurologic clinic in pediatric center of excellence from August 2014 to February 2015 are included in this study. No blinding and randomization were done.
Setting and Conduct:
Childhood Autistic Rating Scale (CARS) questionnaire includes 15 sections. It evaluates cognitive and verbal aspects of Autistic children. Patients receive a grade from 1 to 4 in each of 15 sections. Patients are evaluated again by CARS questionnaire one month after completing the treatment. At the end, according to changes in grades in second evaluation, the efficacy of medication will be evaluated in four aspects of so called questionnaire.
Participants including major eligible criteria:
selected children are required not to receive any kinds of new medications during the recent three months ago and having neither past history of seizure nor intra-cerebral hemorrhage.
Intervention:
Cerebrolysin is prescribed by a supervisor, injected intramuscularly, 1cc in 3 days a week in first month of study, followed by gradual decrease in dose during the second month ( two injections in first week, two injection in second week, one injection in third week and, finally one injection in forth week).
Main outcome measures:
-verbal and non-verbal communication, emotional response, relationship to people
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015100424337N1
Registration date:2015-12-23, 1394/10/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-23, 1394/10/02
Registrant information
Name
mohammad vafaeeshahi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2267 9834
Email address
m-vafaeeshahi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of Cerebrolysin effect on cognitive and verbal aspects of children suffering from autism spectrum disorder
Public title
Cerebrolysin effect On cognitive and verbal aspects of children suffering from autism spectrum disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:All 3 to 10 year-old children suffering from Autism spectrum disorder referred to pediatric neurologic clinic in pediatric center of excellence from August 2014 to February 2015 are included in this study.
Exclusion criteria: receive of any kinds of new medications during the recent three months ago; past history of uncontroled seizure; past history of intra-cerebral hemorrhage.
Age
From 3 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ethics committee of Tehran University of Medical Science
Street address
Ghods Street, Keshavarz Boulevard
City
Tehran
Postal code
Approval date
2015-06-24, 1394/04/03
Ethics committee reference number
IR.TUMS.REC.1394.257
Health conditions studied
1
Description of health condition studied
Autism spectrum disorders
ICD-10 code
F84.0
ICD-10 code description
Primary outcomes
1
Description
Verbal and Non-verbal Communication,Emotional response,relationship to people
Timepoint
Three Months
Method of measurement
Childhood Autism Rating Scale Test
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intramuscular Cerebrolysin injection
1cc in 3 days a week in first month of study, followed by gradual decrease in dose during the second month ( two injections in first week, two injection in second week, one injection in third week and, finally one injection in forth week).
cerebrolysin is a low molecular neuropeptide and free amino acid that has neurotrophic effects.
It is produced in GMP factory ( Australia)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children Medical Center
Full name of responsible person
Mohammad Vafaee-Shahi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tehran University of Medical Sciences
Full name of responsible person
Masoud yunesian
Street address
Tehran University of medical science
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Tehran University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Vice chancellor for research,Tehran University of Medical Sciences
Full name of responsible person
mohammad vafaee-shahi
Street address
children medical center
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Tehran University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Mohammad Vafaee-Shahi
Position
fellow of Pediatric Neurology
Other areas of specialty/work
Street address
Children Medical Center
City
Tehran
Postal code
Phone
+98 21 2267 9834
Fax
Email
dr.vafaeeshahi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Children Medical Center
Full name of responsible person
Mohammad Vafaee-Shahi
Position
Fellow of Pediatric Neurology
Other areas of specialty/work
Street address
Children Medical Center
City
Tehran
Postal code
Phone
+98 21 2267 9834
Fax
Email
dr.vafaeeshahi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Mohammad Vafaee-Shahi
Position
Fellow Of Pediatric Neurology
Other areas of specialty/work
Street address
N64, Gharib Street, Children Medical Center
City
Tehran
Postal code
Phone
+98 21 2267 9834
Fax
Email
m-vafaeeshahi@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)