Management of Autism Spectrum Disorder in children through a comprehensive Ayurveda approach as an add-on to conventional therapy– A randomized control clinical trial

This randomized controlled clinical trial aims to evaluate the efficacy of a comprehensive Ayurveda approach as an add-on to conventional therapy in managing Autism Spectrum Disorder (ASD) in children aged 6–15 years. A total of 80 children diagnosed with mild to moderate ASD (ISAA scores 70–153) will be recruited from therapy centres in Bengaluru and randomly assigned to two groups: one receiving only conventional therapy, and the other receiving conventional therapy alongside Ayurveda treatment. The conventional therapy comprises a 10-month integrated program including occupational therapy, speech therapy, and individualized education plans. The Ayurveda intervention includes the administration of Saraswata Ghrita (6g/day before food) and Ayush Manas tablets (2 tablets twice daily after food) for six months. The primary outcome measure is the Autism Treatment Evaluation Checklist (ATEC) score, with secondary objectives focusing on intellectual ability, adaptive daily living functioning, and parental quality of life. Screening and assessment tools include DSM-5, IASQ, ISAA, WISC, Vineland scales, and QoLA, along with laboratory investigations such as CBC, LFT, RFT, Hs-CRP, IL-6, and TNF-alpha. The trial follows a prospective, open-label design with participants assessed across seven visits over a 6-month treatment period. Ethical clearance is obtained. Informed consent from parents and CTRI registration will be ensured before initiation. Data confidentiality and adverse event monitoring will be maintained throughout the study. The findings aim to provide evidence on the potential benefits of integrating Ayurveda with standard care in improving outcomes for children with ASD.