Testing and Validation of combined Yoga and Ayurveda program for Autism Spectrum Disorder

Phase 3

Not yet recruiting

Conditions: Autistic disorder. Ayurveda Condition: BALAROGAH-SANKIRNA,

Registration Number: CTRI/2023/01/049014

Lead Sponsor: Dr P Sai Manoj

Brief Summary: Autism Spectrum Disorder(ASD) remains to de one of the lifelong disorders which doesnâ€™t have a definitive cure. This causes lot of distress in child as well as the care givers with significant deterioration in their quality of life. The conventional therapies also has limited evidence in treating these children. Yoga therapy in the recent times has shown to have promising results in terms of improving several domains of ASD if done systematically and regularly for a long term. Similarly Ayurveda has also shown efficacy in few reported case studies. However, a combined modality of treatment including both components of Yoga and Ayurveda has been sparse.

Objective: To validate safe and feasible Integrated Yoga and Ayurveda Module (IYAM) for autism spectrum disorder with an objective of improving physical, social and emotional disturbances in ASD children and to test the feasibility IYAM .

NULL HYPOTHESIS:

1. The developed integrated module will not be safe and feasible for practice in patients suffering from ASD in a pilot study.

2. The developed integrated yoga and Ayurveda module will not have positive effect on physical, social and emotional disturbances in ASD children

ALTERNATE HYPOTHESIS:

1. The developed integrated module will be safe and feasible for practice in patients suffering from ASD in a pilot study.

2. The developed integrated yoga and Ayurveda module will have positive effect on physical ,social and emotional disturbances in ASD children (with specific regards to social communication and restricted repetitive behaviours, sleep disturbances, GI disturbances sensory impairments

Design: Open label pilot study

Setting: The trial will be conducted in NIMHANS Integrate Centre for Yoga, NIMHANS.

Subjects: Subjects aged 10 years to 18 years both male and female diagnosed as ASD, satisfying the inclusion criteria would be included in the study.

Interventions: An Integrated Yoga and Ayurveda Management Program will be administered.

Assessments: Autism Treatment Evaluation Checklist (ATEC), Composite Sleep Disturbance Index(CSDI), Gastrointestinal Severity Index(GSI), Yoga Performance Assessment(YPA)

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 15

Inclusion Criteria

Social quotient- above 60% Diagnosis of Autism according to DSM 5, INCLEN Diagnostic Tool Children with mild autism Children with or without aggression Children with or without ADHD Parents education.
Metric Children with or without Psychotropics.

Exclusion Criteria

Neurological disorders of known etiology Significant sensory or motor impairment Major physical abnormalities History of head injuries Children in any neurotrophic medications.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Autism Treatment and Evaluation Checklist ( ATEC)	At baseline and after 3 weeks of intervention

Secondary Outcome Measures

Name	Time	Method
Composite sleep disturbance index (CSDI)	Gastrointestinal severity Index (GSI)

Trial Locations

Locations (1): NIMHANS
🇮🇳
Bangalore, KARNATAKA, India
NIMHANS
🇮🇳Bangalore, KARNATAKA, India
P Sai Manoj
Principal investigator
7842296450
p.saimanoj@gmail.com