Efficacy of Panchabhautika Ghrita Nasya over Astamangala Ghrita Nasya for Cognitive Enhancement in Children with Cerebral Palsy: A Randomised Controlled Trial Protocol

Introduction: Cerebral Palsy (CP) is a neurodevelopmental disorder characterised by impaired movement, muscle tone, and cognition. Cognitive deficits in children with CP significantly impact their quality of life, necessitating effective interventions. Ayurveda offers Panchakarma therapies, including Nasya (nasal administration of medicated ghee or oils), which have traditionally been used for neurocognitive enhancement. Among these, Panchabhautika Ghrita and Astamangala Ghrita are formulations with potential neuroprotective and cognitiveenhancing properties. However, their comparative efficacy remains unexplored through rigorous clinical evaluation. Need of the study: This randomised clinical trial is essential to generate clinical evidence comparing the cognitive outcomes of Panchabhautika Ghrita Nasya versus Astamangala Ghrita Nasya in children with CP. The findings could guide Ayurvedic practitioners in personalised medicine approaches and support policy-level inclusion of validated therapies in paediatric neurorehabilitation. Aim: To compare the efficacy of Panchabhautika Ghrita Nasya and Astamangala Ghrita Nasya in enhancing cognitive functions in children with CP. Materials and Methods: A single-centre, open-label, randomised, parallel-group, controlled superiority clinical trial will be conducted in the Department of Kaumarabhritya, at Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital, Koppal, Karnataka, India. The total duration of the research project will be 30 months. This pilot study is designed as a Randomised Controlled Trial (RCT) with two parallel intervention arms. A total of 106 (53 in each group) children aged between 1 and 2 years diagnosed with CP and cognitive impairment will be recruited and randomised into two groups. Group A will receive Panchabhautika Ghrita Nasya, and Group B will receive Astamangala Ghrita Nasya, once daily on an empty stomach in the morning for 30 days. The interventions will be administered following standard Nasya procedures over the predefined treatment duration. Cognitive function will be assessed using the Mayes Motor Free Assessment Scale, while secondary outcomes such as quality of life and motor function will be evaluated using the Gross Motor Function Classification System (GMFCS). Data will be collected at baseline, midtreatment, post-treatment, and follow-up intervals to assess both immediate and sustained effects. Statistical analysis will include paired t-tests, ANOVA, and regression models to determine within-group and between-group differences. This study will provide scientific evidence on the comparative efficacy of Panchabhautika Ghrita Nasya and Astamangala Ghrita Nasya for cognitive enhancement in children with CP, potentially contributing to integrative management strategies for neurodevelopmental disorders.