Acute and Sub-chronic Toxicity (90-Day) Study of Swamala (SWA)® in Wistar Rats

Background: Swamala (SWA)® is an Ayurvedic proprietary product used in the treatment of general debility and in immune-compromised conditions. Despite its usefulness, there is no published data on toxicity profile of SWA®. Objective: The main objective of the present study was to evaluate safety of SWA® in an acute and 900 day repeated dose toxicity studey in Wistar rats. Methods: SWA® at the doses of 0, 3, 6, and 15 g/kg was administered for 90 consecutive days. Body weights and feed consumption were recorded and analyzed. At termination of the study rats were sacrificed and observed for gross pathological changes. All organ parts were collected, weighed and preserved for histopathological examination and blood was collected from retro-orbital sinus for clinical biochemical analysis. Results: After 90 days of oral administration SWA® did not show any gross toxicological signs and histopathology also when compared with normal. All animals in Group IV showed significant increase in body weight as compared to that of control group animals. No mortality was observed throughout the period. Conclusion: Finally, it was concluded that SWA® having no toxico-pathological effects at a dose of 15 g/Kg which is equivalent to five times the therapeutic dose administered orally for 90 days.