Vol. 2, Issue 2, Part A (2025)

Background: Manasmitra Vatakam (MMV) is a classical Ayurvedic polyherbal and herbomineral formulation traditionally prescribed for neuropsychiatric and cognitive disorders. Despite its long-standing clinical utilization, comprehensive scientific evidence regarding its toxicological safety profile possesses remained limited. This study aimed to systematically evaluate the in vivo toxicity and safety parameters of MMV through standardized animal experimentation.
Methods: A 90-day sub-chronic oral toxicity study was conducted on Wistar rats in accordance with OECD guidelines 423 and 407. Animals were divided into four groups control, therapeutic equivalent dose (TED), 5×TED, and 10×TED and assessed for clinical signs, body weight, food intake, hematology, serum biochemistry, organ weight, genotoxicity, and histopathological changes. Statistical analysis was performed using one-way ANOVA followed by Tukey’s post hoc test with p < 0.05 considered significant.
Results: No mortality, behavioural abnormalities, or clinical signs of toxicity were observed in any dose group. Body weight gain, hematological and biochemical parameters remained within physiological limits across all treatment groups. Minor, non-significant elevations in serum ALT and AST at 10×TED did not correlate with histopathological changes, indicating absence of hepatocellular damage. Renal indices and relative organ weights were stable across all groups. Micronucleus assay results confirmed the absence of genotoxicity. Heavy metal analysis revealed acceptable limits for Pb, Cd, Hg, and As, ensuring formulation safety. Based on the combined biochemical, histological, and genotoxic endpoints, the No Observed Adverse Effect Level (NOAEL) was established at 10×TED.
Conclusion: MMV exhibited a high degree of systemic safety and biocompatibility in sub-chronic oral administration, validating its traditional therapeutic utilization. The findings support its safe integration into modern clinical practice and emphasize the need for continued pharmacovigilance and standardization. Practically, GMP-certified production, strict quality control, and adherence to therapeutic dosing are recommended for clinical utilization. Further research on chronic and reproductive toxicity, pharmacokinetic profiling, and herb-drug interaction studies is warranted to strengthen its translational and regulatory acceptance.