Efficacy of Ayurveda Treatment Protocol in Autism Spectrum Disorder

Phase 2

Not yet recruiting

Conditions: Autistic disorder. Ayurveda Condition: MANOVAHASROTODUSHTIH,

Registration Number: CTRI/2025/03/082928

Lead Sponsor: National Institute of Ayurveda deemed to be university

Brief Summary: Autism spectrum disorder is a neurodevelopmental and behavioural disorder that is characterised by a deficit in reciprocal social communication and stereotypical repetitive and restricted behaviour It is a complex impairment often appearing in early childhood The etiology is multifactorial and not fully understood Autism spectrum disorder ASD encompasses autistic disorder Aspergers syndrome and pervasive mental disorderThe clinical manifestations of ASD varies depending on the severity of the disorder The prevalence of autism is rapidly increasing over the yearsThe global prevalence of autism is 1 in 100 as per the World Health Organization According to CDCs Autism and Developmental Disabilities Monitoring ADDM network about 1 in 36 children have been diagnosed with autism The prevalence of autism in India is 1 in 68 as per a study published in the Indian Journal of Pediatrics About 18 million children are affected by autism Autism is 4 times more common in boys than girls Globally there has been a notable surge in occurrence of autism spectrum disorder Despite a lot of medical advancements there are no medications specifically to treat autism Secondgeneration antipsychotics risperidone and aripiprazole are two drugs that the US Food and Drugs Administration has approved for the treatment of autism It is efficacious in reducing some symptoms but it carries the risk of side effects like excessive weight gain hyperglycemia drowsiness sedation tremors and muscle stiffness The children may get relief from the previous symptoms with lots of new ones getting added Occupational therapy a psychosocial intervention is more popular in the management of autism that requires a significant investment of time and money placing a financial burden on families This increases a concern in health care professional and researchers ASD can be considered as a global pandemic which needs an early and effective intervention There is an equal and profound impact on the daytoday life of autistic individuals and their families The management of autism needs to be a multidisciplinary approach So in this context Ayurveda may play a significant role in the management of wellbeing cognition and overall behaviour Three treatment modalities are explained in the classical texts ofAyurveda viz daivavyapashraya yuktivyapashraya and sattvavajaya chikitsa This is a wholesome approach dealing with the physical mental as well as emotional wellbeing of the patient with minimal consumption of time and is costeffective This study is carried out to evaluate the effect of this treatment protocol in the management of ASD

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Those meeting DSM V TR and AIIMS modified INCLEN criteria ISAA score more than 70.

Exclusion Criteria

One who doesn’t meet DSM V TR and AIIMS modified INCLEN criteria Children having any other psychotic or neurological disorder.
Children having any co-morbid conditions or congenital disorder / genetic syndromes.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in ISAA score	at baseline 4 weeks \| 8 weeks 12 weeks

Secondary Outcome Measures

Name	Time	Method
Development of Ayurveda protocol for the management of ASD	12 weeks

Trial Locations

Locations (1): National Institute of Ayurveda Hospital
🇮🇳
Jaipur, RAJASTHAN, India
National Institute of Ayurveda Hospital
🇮🇳Jaipur, RAJASTHAN, India
Dr Pallavi Mishra
Principal investigator
8107372634
mishpall13@gmail.com