A clinical trial to study the additional benefit of Ayurveda treatment along with Behavioral therapy in the management of Autism Spectrum Disorder.
Phase 3
- Conditions
- Health Condition 1: F840- Autistic disorder
- Registration Number
- CTRI/2023/05/052867
- Lead Sponsor
- All India Institute of Ayurveda, New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Children between 3-9 years of age fulfilling the diagnostic criteria for mild to moderate form of Autism using Childhood Autism Rating Scale (CARS-2)
2.Parents / Guardian willing to give informed written consent to participate in the study
Exclusion Criteria
1.Children with severe intellectual disability and diagnosed genetic and metabolic disorders.
2.Children currently on behavior therapy, occupational therapy, speech therapy, autism specific dietary intervention and any complementary and alternate medicine for Autism.
3.Children with chronic ailments like tuberculosis, malignancy, juvenile Diabetes mellitus and any other chronic systemic illness.
4.Children taking anti-epileptic and anti-psychotic drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effectiveness of the Ayurveda Treatment Protocol in reducing the core clinical features i.e. social communication and interaction and restricted, repetitive behaviors of ASD using Childhood Autism Rating Scale (CARS-2).Timepoint: 0 day, 90th day and 180th day
- Secondary Outcome Measures
Name Time Method Changes in the behavioral problems i.e. Irritability, Social Withdrawal, Stereotypic behavior, Hyperactivity and inappropriate speech using Aberrant Behavior Checklist. <br/ ><br>Changes in the adaptive and social functioning using Vineland Social Maturity Scale.Timepoint: 0 day, 90th day and 180th day.