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

Autism 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 <i>Saraswata Ghrita</i> and <i>Ayush Manas</i> possess neuroprotective, anti-inflammatory, antioxidant, and cognition-enhancing properties, but robust clinical evidence supporting their adjunctive use in ASD is limited. The 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. This randomized, open-label, parallel-group, active-controlled clinical trial will enroll 80 children aged 6 to 15 years diagnosed with ASD according to <i>DSM-5</i> (<i>Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition</i>) criteria at the Central Ayurveda Research Institute (CARI), Bengaluru, in collaboration with selected autism therapy centers. Participants will be randomized in a 1:1 ratio to receive either conventional therapy alone or conventional therapy combined with <i>Saraswata Ghrita</i> and <i>Ayush Manas</i> for 6 months. Outcome assessments will be performed at predefined intervals using the Autism Treatment Evaluation Checklist (ATEC), Indian Scale for Assessment of Autism (ISAA), Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV), Vineland Adaptive Behavior Scales, Third Edition (VABS-III), and Quality of Life in Autism (QoLA) questionnaire. Exploratory laboratory assessments include high-sensitivity C-reactive protein, interleukin-6, and tumor necrosis factor-alpha (TNF-&#x3b1;). Safety will be evaluated through adverse event monitoring and laboratory investigations. Statistical analysis will be performed after data verification. Data normality will be assessed using the Shapiro-Wilk test. Variables will be represented as frequencies (%), mean (SD), or median with IQR. Preintervention and postintervention comparisons will use repeated-measures ANOVA or the Friedman test, as appropriate, with significance set at <i>P</i>&lt;.05, using STATA software (version 18.0; StataCorp LLC). Ethical 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. The 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.