A study to observe additional effect of ayurvedic treatment on Autism Spectrum Disorder in Children
- Conditions
- Autistic disorder,
- Registration Number
- CTRI/2020/06/025871
- Lead Sponsor
- Dr Snehal Vinayak Kale
- Brief Summary
This study is a Randomized parallel group open label clinical trial to assess the clinical efficacy of Ayurvedic treatment modalities in the Management of Autism Spectrum Disorder in Children. For that Mahapaishachik Ghrita will be orally administered 3-16 gm (as per age of child of 3-16 years) twice daily with luke warm water or milk for 3 months, Nasal instillation (Nasya) of Brahmi Ghrita 2 drops in each nostril once daily for 3 months, External application of oil over head (Shiroabhyanga) with Ksheer Bala Taila (10-20 ml) for 10 minutes for 3 months, Ayurvedic foot massage (Padabhyanga) with Ksheer Bala Taila (10-20 ml) for 10 minutes (5 minutes on each foot) will be done before going to bed for 3 months along with Non Pharmacological therapies in children suffering from Autism Spectrum Disorder.
To keep the transparency of distinguishing the exact effect of special treatment subject in trial group will be divided into two phases and treated i.e. Control group with only Non Pharmacological therapies for 6 months while Trial group treated with Non Pharmacological therapies for first 3 months (Phase I) and with Ayurvedic treatment modalities along with Non Pharmacological therapies for next 3 months (Phase II).
The primary outcome is reduction in the clinical features of Autism Spectrum Disorder and the secondary outcome will be changes in the quality of life of parents at 90 days and 180 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 40
Fulfilling the diagnostic Criteria of Autism Spectrum Disorder according to -Diagnostic and Statistical Manual of Mental disorders Fifth edition (DSM-5TM)(299.00) -Childhood Autism Rating ScaleTM Second edition (CARSTM2) -Indian Scale for Assessment of Autism (ISAA) Parents/ Guardian willing to give informed written consent to participate in the study.
Children below 3 years and above 16 years Presence of other organic or psychotic neurological disorder Hearing and visual impairment, Multiple disabilities Patients with acute and chronic systemic illness such as renal diseases, Hepatic dysfunction, Juvenile diabetes mellitus, malignancy, etc Progressive and non progressive neuromuscular disorders, Known neurodegenerative disorder Hypoxic Ischemic Encephalopathy (HIE) Endocrinal disorders, Protein Energy Malnutrition (PEM),etc Children taking anti-epileptic and anti-psychotic drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in clinical features of Autism Spectrum Disorder assessed by 1.Autism Treatment Evaluation Checklist (ATEC) Baseline 0 day and 90 days and End of treatment 180 days 2.Childhood Autism Rating Scale TM Second edition (CARSTM2) Baseline 0 day and 90 days and End of treatment 180 days 3.Indian Scale for Assessment of Autism (ISAA) Baseline 0 day and 90 days and End of treatment 180 days
- Secondary Outcome Measures
Name Time Method Changes in the quality of life of Parents
Trial Locations
- Locations (1)
Yashwantrao Chavan Ayurved Hospital Aurangabad
🇮🇳Aurangabad, MAHARASHTRA, India
Yashwantrao Chavan Ayurved Hospital Aurangabad🇮🇳Aurangabad, MAHARASHTRA, IndiaDr Snehal Vinayak KalePrincipal investigator8956072783snehalvkale088@gmail.com