Clinical study on the efficacy of Kalyanaka Leha Churna (Poly-herbal Ayurveda Powder) and Yapana Basti (Medicated Enema) in Language and Communication Disorders secondary to Autism Spectrum Disorder (ASD)– Study Protocol

Abstract

Background: Autism Spectrum Disorder (ASD), in children is characterised by neuro-developmental challenges, which lack pharmaceutical solutions, making behavioural interventions the primary treatment in the contemporary system. Ayurveda offers a holistic approach to treating the condition with a combination of herbs-mineral medicines and Panchakarma therapies. This clinical study investigates the efficacy of Ayurveda interventions, specifically Kalyanaka Leha Churna, a poly-herbal powder commonly used in speech disorders of children and Yapana Basti, a poly-herbal decoction enema in addressing language and communication disorders secondary to ASD. Objectives of the Study: The primary objectives include assessing the effectiveness of Ayurveda intervention with the standard control therapies on the clinical features of ASD concerning speech. Materials and methods: The present trial has been approved by the IEC (JSSAMC/1106/2022-23) and duly registered in the clinical trial registry of India (CTRI/2023/07/055877). Twenty subjects in each group, aged 3-6 years, diagnosed with language and communication disorders secondary to ASD, will be recruited from various centres in and around Mysuru, Karnataka. Assessments will utilise the Indian Scale for Assessment of Autism (ISAA), Receptive and Expressive Emergent Language Scale (REELS), and Communication Deall Developmental (COMDEALL). Statistical analyses, including the Wilcoxon sign rank test, will be employed to evaluate the results. Conclusion: Language and Communication Disorders secondary to ASD are not an uncommon condition in children in the current day. Ayurveda classifies such a clinical condition under the ambit of ‘Unmada’. The difficulty to communicate has many negative consequences in children including poor academic performance, quality of life and behavioural problems. A significant result of therapy can be just supplementing speech as such or by any other means. This study aims to provide insights into the potential role of Ayurveda in this condition which will help in enhancing the quality of life for children with ASD and their families, presenting a holistic approach.