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 ofsignificant histopathological damage supports its safe use in traditional medicine. Further studies are
recommended to validate these findings in clinical settings.
Keywords: Ksharagada, Physicochemical Analysis, Anticancer, Herbo-mineral Formulation,
Drug-induced Toxicity
Publication date: 01/07/2024
https://ijbpas.com/pdf/2024/July/MS_IJBPAS_2024_8205.pdf
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https://doi.org/10.31032/IJBPAS/2024/13.7.8205
