Acute and sub-chronic toxicity assessment of herbal formulation garlina in oryctolagus cunniculus rabbits

ABSTRACT

The purpose of this study was to determine the safety profile of a polyherbal drug, Garlina. The acute toxicity was carried out at 5000 mg/kg administered orally while sub-chronic toxicity was assessed by daily oral dosing of 2000mg/kg in rabbits following ABPI and BTS guideline, 2009 and EMA, 2000, respectively. The outcomes of Garlina-treated group were compared with control group that received saline. The results of Garlina administered orally once at a dose of 5000 mg/kg and 2000 mg/kg/ day consecutively for a period of one month does not produce any remarkable adverse effects when analyzed histopathologically or biochemically. Similarly, hematological profile, body and organs weight also remained unchanged in its presence. However, a significant increase in uric acid at a single dose of 5000 mg/kg and a decline in RBCs count at the dose of 2000 mg/kg of Garlina were observed that will be monitored cautiously in the on-going clinical trials. The findings obtained in this study suggest that at prescribed dose Garlina is relatively safe for human consumption