An Experimental Study to Evaluate Acute and Sub-Acute Oral Toxicity of Ksharagada on Wistar Albino Rats

Introduction: Drug-induced toxicity represents the adverse effects arising from pharmaceutical substances, potentially leading to severe complications.This study investigates Ksharagada (KA), a traditional Ayurvedic herbo-mineral formulation, for its safety profile through acute and sub-acute oral toxicity studies in female Wistar albino rats.Materials and Methods: Ksharagada was prepared using traditional methods, and its physicochemical properties were analyzed.Acute toxicity was assessed using five rats at doses of 2000 mg/kg and 5000 mg/kg, while sub-acute toxicity involved 24 rats divided into control and three dosage groups (540 mg/kg, 810 mg/kg, and 1080 mg/kg) over 28 days, followed by a 14-day observation period.Various biochemical parameters and histological examinations were conducted following OECD guidelines.Results: In the acute toxicity study, all rats survived without observable toxicity at doses up to 5000 mg/kg.The sub-acute study showed significant alterations in biochemical parameters, such as increased total bilirubin and decreased SGPT, SGOT, ALP, total protein, creatinine, urea, and uric acid in higher dose groups, suggesting potential hepatic and renal impacts.However, histopathological examinations of vital organs revealed no toxic effects. Conclusion:Ksharagada demonstrated a high safety margin in both acute and sub-acute toxicity studies, with an LD50 above 5000 mg/kg.Despite some biochemical alterations, the absence of