S Nilakash, V. G. Jonnalagadda*, M. B. Chawda, K. S. Thakur, M. K. Vahalia, S. S. Shitut
Abstract
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
a 90 day repeated oral dose toxicity test 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.