(1) Objectives: Assessment he efficacy of augmentation Flavonoid Quercetin to risperidon in treatment of autism spectrum disorders. (2) Participants including major eligibility criteria: Eligible patients after gaining the consent of a parent or legal guardian patients will be enrolled. Patients who had organic disease, patients have been treated with other psychotropic drugs and also patients with other psychiatric disorders are excluded (3 ) Autism spectrum disorders 3-12 years old , The samples were randomly divided into two groups of 35 persons.(4) Intervention: Both groups were treated with Risperidone prior to entering the study, first group is treated with placebo and the second group is treated with Flavonoid Quercetin , Patients at weeks zero, six, towelve in terms of therapeutic effects and adverse drug reactions are evaluated. Results of the study will be assessed by CARS, CGI questionnaire and check list of drugs side effects (5) Main outcome measures (variables): Severity of Autism
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017013132326N1
Registration date:2017-04-06, 1396/01/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-06, 1396/01/17
Registrant information
Name
Narges Nejati Fard
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3601 6683
Email address
nejatifardn931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Mashhad University of Medical Sciences
Expected recruitment start date
2017-03-05, 1395/12/15
Expected recruitment end date
2017-11-06, 1396/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the efficacy of augmentation Flavonoid Quercetin to risperidon in treatment of autism spectrum disorders
Public title
The efficacy of augmentation Flavonoid Quercetin to risperidon in treatment of autism spectrum disorders
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria: Of all patients with ASD, ranging in age from 3to 12years; Parent's Consent; No obvious organic disease; The lack of other psychiatric disorders; Not taking other psychoactive medications other than risperidone; IQ higher than 50 on the basis of Weiland test.
The exclusion criteria: In the absence of cooperation of parents after inclusion; the risk of any side effect or another disease that cause a problem in results.
Age
From 3 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Mashhad University of Medical Sciences
Street address
Qoreishi Building, Daneshgah St
City
Mashhad
Postal code
1394491388
Approval date
2017-01-11, 1395/10/22
Ethics committee reference number
IR.MUMS.fm.REC.1394.459
Health conditions studied
1
Description of health condition studied
Autism Spectrum Disorders
ICD-10 code
F84
ICD-10 code description
Pervasive developmental disorders
Primary outcomes
1
Description
Severity of Autism
Timepoint
Previous the syudy, 6 weeks after study, 12 weeks after study.
Method of measurement
CARS test,CGI test
2
Description
Response to treatment
Timepoint
Previous the syudy, 6 weeks after study, 12 weeks after study.
Method of measurement
CARS test,CGI test
Secondary outcomes
1
Description
Drug's side effect
Timepoint
Previous the study, 6weeks after study, 12weeks after study
Method of measurement
Check list
Intervention groups
1
Description
The intervention group have been treated with risperidone(maximum dose 2 mg) is also treated with placebo. The duration of intervention is 12 weeks.
Category
Treatment - Drugs
2
Description
The intervention group have been treated with risperidone (maximum dose 2mg ), is also treated with Flavonoid Quercetin . Dosing and titration of the drug individually, but the total dose of Flavonoid Quercetin is75 mg per10 kg at the start ,(PO) and the duration of intervention is 12weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Outpatient Clinic
Full name of responsible person
ِDr Narges Nejati Fard
Street address
Ibne Sina Hospital
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Mashhad University of Medical Sciences
Full name of responsible person
Dr Mahyar Mirheydari
Street address
Qoreishi Building, Daneshgah St
City
Mashhad
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 of Mashhad University of Medical Sciences