TOXICOLOGICAL EVALUATION OF TRIVANGA BHASMA (TRIMETALLIC AYURVEDIC FORMULATION) IN ANIMAL MODEL VIA 28-DAY REPEATED ORAL DOSE

Context: Ayurveda emphasizes applying herbal, metallic, mineral, and herbo-mineral preparations in therapeutics. Trivanga Bhasma (TB) is a potential trimetallic (Tin, Lead & Zinc) compound formulation widely used in routine Ayurvedic practice to treat several chronic ailments. Objective: To elucidate the toxicity profile of TB by oral administration in wistar albino rats to ascertain the safety aspects. Method: TB was administered in possible higher doses such as TED (Therapeutic Equivalent Dose), TED × 2 (2 times the Therapeutic Equivalent Dose), TED × 5 (5 times the Therapeutic Equivalent Dose) and TED × 10 (10 times the Therapeutic Equivalent Dose) for 28 days. The effect was assessed on ponderal changes, biochemical parameters, histopathology, and tissue analysis. Results: Results showed that TB did not induce any toxicity at TED, TED × 2, TED × 5; whereas histopathology and tissue analysis of very higher dose TED × 10 exhibited toxicity in the liver & kidney. Conclusion: The drug, however, at a dose of TEDx10 showed mild undesirable changes in the liver & kidney; the experiential variations were not observed at TED (Therapeutic Equivalent Dose) and TED × 2 (2 times the Therapeutic Equivalent Dose). Hence, it is concluded that the Trivanga Bhasma prepared as per the classical method is safe for consumption at the recommended therapeutic dose level.