Safety evaluation of Shwasakuthara Rasa (herbo-mineral Ayurvedic formulation): A 90-day repeated-dose oral toxicity study in Wistar albino rats
Deeksha Kango, Dipali N. Parekh, Swapnil Chaudhari, Mukesh Nariya, Biswajyoti PatgiriAbstract
BACKGROUND:
METHODS:
A repeated-dose 90-day oral toxicity study of SKR was performed in Wistar albino rats to evaluate its subchronic toxicity profile. Animals were administered daily oral doses corresponding to the therapeutic equivalent dose (TED; 22.5 mg/kg), TED×5 (112.5 mg/kg), and TED×10 (225 mg/kg), with an additional TED×10 recovery group. The formulation was administered with honey as an adjuvant for 90 days, followed by a 30-day recovery period. Subsequently, the hematological, biochemical, and histopathological parameters were evaluated.
RESULTS:
Administration of SKR did not cause significant changes in the hematological or serum biochemical parameters across all doses. Histopathological analysis revealed minor hepatic alterations, including unifocal necrosis and fatty degeneration in one rat treated with the highest dose. However, rats in the recovery group showed normal liver architecture, indicating that the observed changes were reversible. These findings suggest that SKR, when prepared and administered following traditional Ayurvedic guidelines, does not exhibit significant toxicity, even at elevated doses and with repeated administration. The reversible nature of the hepatic changes supports its safety profile, highlighting SKR’s suitability for clinical use without causing systemic toxicity.
CONCLUSION:
Repeated oral administration of SKR for 90 days did not elicit significant treatment-related toxicological effects in Wistar rats, establishing a no-observed-adverse-effect level (NOAEL) of 225 mg/kg (p.o.). These findings support its favorable preclinical safety profile and provide a translational framework for future clinical studies assessing its therapeutic potential and long-term safety.