Physicochemical and Phytochemical Evaluation of Siddha Formulation Vani Vallari Nei for Safety and Clinical management of cerebral palsy

Abstract

Background:The Siddha system of medicine, one of the oldest traditional healing practices in South India, utilizes ghee-based (Nei) formulations for enhancing drug delivery and therapeutic efficacy, particularly in neurological conditions like Cerebral palsy (CP). Vani Vallarai Nei (VVN), a classical Siddha preparation containing Centella asiatica, Picrorhiza kurroa, Clitoria ternatea, and Acorus calamus processed in clarified ghee, is traditionally indicated for improving memory and managing neurological disorders including cerebral palsy. Despite its therapeutic relevance, scientific validation of its quality and safety has been limited.

Materials and Methods:  The formulation, VVN was subjected to comprehensive standardization in line with WHO and AYUSH guidelines. The raw drugs were authenticated, purified, and formulated using classical Siddha procedures. Physicochemical characterization included parameters such as specific gravity, pH, moisture content, iodine value, saponification value, unsaponifiable matter, acid and peroxide values, and total fatty matter.

Results: Phytochemical screening of different extracts was carried out, followed by HPTLC fingerprinting to establish identity. Safety profiling involved heavy metal quantification, microbial load assessment, aflatoxin screening, pesticide residue evaluation, and stability testing over 12 months. The formulation exhibited acceptable physicochemical parameters with high fatty matter content and absence of rancidity. Phytochemical analysis revealed the presence of phenolics, tannins, terpenoids, cholesterol, quinones, and fixed oils. HPTLC provided distinct chromatographic fingerprints, supporting authentication. Heavy metals, microbial contaminants, and aflatoxins were either absent or within permissible limits, while pesticide analysis indicated compliance with AYUSH standards. Stability evaluation confirmed microbial safety and toxin-free status up to one year.

Conclusion: In conclusion, the results affirm that Vani Vallarai Nei is a stable, safe, and standardized Siddha formulation. These findings provide a strong scientific basis for its traditional use in managing neurological conditions, highlighting its potential as a supportive therapy for cerebral palsy.