Protocol for a Multicenter, Controlled, Two-Arm Clinical Study Evaluating the Efficacy of Ayurvedic Therapeutic Interventions and Swarnaprashana for Autism Spectrum Disorder in Children

Abstract

Introduction: Autism spectrum disorder (ASD) is a neurobiological disorder with an early childhood onset characterised by Impairment in social communication and social interaction accompanied by restricted and repetitive behaviours. Surge in prevalence of autism in last two decades gained more attention to look for effective management and very limited research studies are available in the management of autism through Ayurveda. There is a need for studying effectiveness of Ayurveda therapy in wider population to draw some inferences regarding effectiveness of same. Autism manifestations can be correlate with doshaja unmade lakshanas and by considering the tridosha with rajo, tamodushti and Agni dushti in causation of unmada, Chikitsa targeting dosha shamana and correction of Agni was considered for current clinical trial. Materials and methods: The current trial comprising of 46 diagnosed children of autism, where trial group will receive selected Ayurveda treatment such as Udgarshana, Sarvanga Parisheka, Matra Basti, and Narthaki samvahana with oral administration of Swarnaprashana for a period of 90 days. The participants in the control group will receive Occupational Therapy at Academy for severe handicap and autism (ASHA) for a period of 90 days. Conclusion: The result could potentially aid in establishing therapy based Ayurveda intervention with oral administration of Swarnaprashana to be effective as occupation therapy in the management of autism.

Trial registration: Clinical trial registry of India (CTRI – CTRI/2023/06/053937)