Determining the effect of cinnarizine in control of behavioral symptoms in children with autism
Design
Double-blind randomized clinical trial
Settings and conduct
Children's medical center
34 Children between the ages of 2 and 7 who have been diagnosed with autism by a psychiatrist are enrolled. First, the Behavioral Problems List Questionnaire for people with intellectual disabilities, is completed by the patient's parents or his/her legal guardian. thereafter, patients are divided randomly into 2 groups of 17 people. Cinnarizine or placebo is randomly assigned to each group and patients take it for 3 months (Researcher and also parents don't know the patient belongs to which group). After 3 months, the same questionnaire is filled out again. Finally, patient's scores from the questionnaires are compared to each other and the results are interpreted.
Participants/Inclusion and exclusion criteria
Childeren with 2-7 y.o.
Diagnosed with Autism based on DSM-5 criteria
Intervention groups
Receiving Cinnarizine 10-15 mg/kg once daily for 3 months
Main outcome variables
Patient's score from the Behavioral problems questionnaire for people with intellectual disabilities
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110628006907N16
Registration date:2022-01-07, 1400/10/17
Registration timing:prospective
Last update:2022-01-07, 1400/10/17
Update count:0
Registration date
2022-01-07, 1400/10/17
Registrant information
Name
Mahmoudreza Ashrafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6612 9252
Email address
ashrafim@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-20, 1400/10/30
Expected recruitment end date
2022-07-22, 1401/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Interventional comparison of the effect of cinnarizine with placebo on mood swings and self-harm and stereotyped behaviors of autistic patients
Public title
The effect of Cinnarizine on Autism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 2-7 years old
Diagnosed with Autism based on DSM5 criteria which is approved by a psychiatrist
Exclusion criteria:
Conditions other than Autism justifying the symptoms of patient
Age
From 2 years old to 7 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Individual simple randomization
34 3-letter codes are generated using www.randomcodegenerator and then half of these codes is assigned to "intervention group" and the other half to "control group". Cinarrizine or placebo (pills are completely identical) are put into identical pockets based on the codes tagged on them. Then the pockets are mixed up. Each patient will recieve a pocket with a code on it which neither researcher or patient don't know whether it belongs to intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
first, 34 3-letter codes will be randomly generated. Each code will be randomly assigned to either control or intervention group. Cinnarizine or placebo pills are put into completely identical pockets and 3-letter codes are written on them. pockets will be mix up. patients or researcher won't know the whether the pocket contains cinnarizine or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences
Street address
Building no.1, Northern gate of the university, Poursina St. Qods St. Enqelab St.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-12-26, 1400/10/05
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1138
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
Patient's score from the Behavioral problems questionnaire for people with intellectual disabilities
Timepoint
at the beginning of trial and 3 months later
Method of measurement
Behavioral problems questionnaire for people with intellectual disabilities
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (17 patients): Receiving Cinnarizine 10-15 mg/kg once daily for 3 months
Category
Treatment - Drugs
2
Description
Control group (17 patients): Receiving placebo 10-15 mg/kg once daily for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical Center
Full name of responsible person
Roya Haghighi
Street address
Gharib
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6693 0024
Email
r.haghighi89@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
keshavarz
City
Tehran
Province
Tehran
Postal code
-
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mahmoudreza Ashrafi
Position
Professor of pediatric neurology
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Gharib Street, Children's Medical Center
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6612 9252
Fax
+98 21 6612 9252
Email
ashrafim@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahmoudreza Ashrafi
Position
Professor of pediatric neurology
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Gharib Street, Children's Medical Center
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6612 9252
Fax
+98 21 6612 9252
Email
ashrafim@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahmoudreza Ashrafi
Position
Professor of pediatric neurology
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Gharib Street, Children's Medical Center
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6612 9252
Fax
+98 21 6612 9252
Email
ashrafim@tums.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
All collected data about primary and secondary outcomes
When the data will become available and for how long
After the publication of the paper
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
Data can be used if the authors’ names were mentioned
From where data/document is obtainable
Email
What processes are involved for a request to access data/document
After receiving the request we will consult with all authors and the data can be shared in a week