Multidimensional Evaluation of the Efficacy of a Comprehensive Ayurveda Approach as an Add-On to Conventional Therapy in Children With Autism Spectrum Disorder: Protocol for a Randomized, Open-Label, Parallel-Group, Active-Controlled Clinical Trial

Abstract BackgroundAutism spectrum disorder (ASD) is a heterogeneous neurodevelopmental disorder characterized by impairments in social communication, restricted and repetitive behaviors, and deficits across multiple developmental domains. Although conventional interventions, including speech, behavioral, and occupational therapies, improve functional outcomes, many children continue to experience persistent cognitive and adaptive impairments. Ayurvedic formulations such as Saraswata GhritaAyush Manas ObjectiveThe study aims to evaluate the efficacy of a comprehensive Ayurveda intervention as an adjunct to conventional therapy in children with ASD by assessing changes in behavioral symptoms, intellectual functioning, adaptive behavior, parental quality of life, and exploratory inflammatory biomarkers. MethodsThis randomized, open-label, parallel-group, active-controlled clinical trial will enroll 80 children aged 6 to 15 years diagnosed with ASD according to DSM-5Diagnostic and Statistical Manual of Mental Disorders, Fifth EditionSaraswata GhritaAyush ManasP ResultsEthical approval was obtained before study initiation, and the trial was registered with the Clinical Trials Registry–India (CTRI/2025/04/085035). Participant recruitment commenced on December 3, 2025. As of July 17, 2026, 20 participants had been enrolled and completed baseline assessments; 14 had completed the 90-day follow-up, and 2 had completed the 6-month intervention. Recruitment is expected to continue until August 2027, followed by completion of participant follow-up, data analysis, and dissemination of study findings. ConclusionsThe study will provide high-quality evidence regarding the effectiveness of integrating Ayurveda with conventional therapy for children with ASD. By simultaneously evaluating behavioral, cognitive, adaptive, quality-of-life, and exploratory biological outcomes, the trial is expected to strengthen the evidence base for multidisciplinary integrative care and inform the development of standardized treatment strategies for ASD.