Subchronic oral toxicity assessment of Ayurvedic herbo-metallic formulation Mahalaxmi Vilas Rasa in Wistar rats

Abstract BACKGROUND: Mahalaxmi Vilas (MV) Rasa, a revered Ayurvedic herbo-metallic formulation, holds historical significance for its therapeutic potential. In light of its traditional use, a rigorous evaluation of its safety profile in Wistar rats is imperative for establishing its evidence-based safety. This study aims to contribute valuable insights to the scientific community and healthcare practitioners, facilitating informed decision-making regarding the integration of MV into contemporary medical practices. The findings hold relevance for advancing our understanding of Ayurvedic formulations in the context of safety and efficacy, fostering a bridge between traditional wisdom and modern scientific scrutiny. METHODS: In the present study, a total of 24 Wistar rats were randomly divided into four groups as one control vehicle and three dose levels of the test drug MV Rasa. The test drug was made into suspension in a vehicle (honey-to-water ratio, 2:3) and administered orally once a day for 90 consecutive days in three dose levels (51.36, 205.44, and 513.6 mg/kg). Clinical observations, body weight changes, and food and water consumption were noted during the study. Then, on the 91st day, rats were sacrificed humanely, and parameters, such as hematological, biochemical, relative organ weight, and histopathological changes, were studied. RESULTS: There was a significant decrease in water intake in high-dose group rats (513.6mg/kg) in the weeks 1, 3, and 4, as compared with control group rats, the observed effect was not treatment related. In addition, MV (51.36, 205.44, and 513.6 mg/kg) produced no significant alterations in any of the hematological and biochemical parameters, except for a significant increase in direct bilirubin in the moderate dose group (205.44 mg/kg). However, no considerable cellular changes were found in the organs analyzed. CONCLUSION: MV had no toxic effect in Wistar rats during this repeated dose oral toxicity (90 days) study, even at 10 times the therapeutic dose (513.6 mg/kg). This was evidenced by their normal behavioral, hematological, biochemical, and histopathological examinations.