JMIR Publications

ABSTRACT

Background:

Autism Spectrum Disorder (ASD) is a heterogeneous neurodevelopmental condition marked by deficits in multiple developmental domains, having a multifactorial origin. Despite extensive use of standard conventional interventions, such as speech, behaviour, and occupational therapies in ASD, the functional limitations in individuals persist, necessitating the need for a multifaceted, comprehensive approach. Neurocognitive Ayurvedic formulations, such as Saraswata Ghrita and Ayush Manas, have demonstrated cognitive-enhancement effects; however, they lack systematic evidence evaluating this integration.

Objective:

The core objective of this study is to evaluate the efficacy of comprehensive Ayurveda management as an add-on to conventional therapy, specifically assessing changes in intellectual ability and adaptive functioning, along with parental quality of life outcomes.

Methods:

This randomized, open-label, parallel group, active-controlled clinical trial will recruit participants aged 6 to 15 years, diagnosed with ASD according to DSM-5 diagnostic criteria. The study is being conducted at the Central Ayurveda Research Institute (CARI), Bengaluru, in coordination with selected therapy centres in Bengaluru that provide conventional ASD care. In total, 80 participants will be randomised in a 1:1 ratio to receive a comprehensive Ayurvedic intervention (Ayush Manas and Saraswata Ghrita) alongside conventional therapy (Speech, Behavioural and Occupational Therapy), or conventional therapy alone, for 6 months. Multiple follow-ups will be conducted at 30-day intervals. Outcomes will be assessed using the Autism Treatment Evaluation Checklist, Wechsler Intelligence Scale for Children, Vineland Adaptive Behaviour Scales (daily living domain), and Quality of Life in Autism Questionnaire for parents. Safety monitoring will be through adverse event reporting. Statistical analysis will be performed after data verification. Data normality will be assessed using the Shapiro-Wilk test. Variables will be represented as frequencies (%) or mean ±SD or median with interquartile range. Pre and post intervention comparisons will use repeated measure ANOVA or Friedman tests as appropriate, with significance set as P < 0.05 using STATA software 18.0. The study protocol has received approval from the Institutional Ethical Committee of CARI, Bengaluru, and has been duly registered with the Clinical Trials Registry, India.

Results:

This ongoing clinical trial was funded in August 2024. Participant recruitment and data collection commenced in December 2025 and have enrolled 15 participants as of March 2026. Recruitment and follow-up are in progress. The study findings will be disseminated through peer-reviewed publications.

Conclusions:

The current study fosters a significant multidisciplinary approach towards the evidence base of Ayurveda with conventional ASD therapy. Its outcomes are expected to imperatively contribute to the development of standardised treatment modules for children with ASD, particularly in the absence of universally established gold-standard guidelines. Clinical Trial: CTRI/2025/04/085035 dated April 17, 2025. https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTI5OTcw&Enc=&userName=