Abstract Title:

Evaluation of the genotoxic potential and acute oral toxicity of standardized extract of Andrographis paniculata (KalmCold).

Abstract Source:

Food Chem Toxicol. 2009 Aug;47(8):1892-902. Epub 2009 May 15. PMID: 19447157

Abstract Author(s):

C V Chandrasekaran, P Thiyagarajan, K Sundarajan, Krishna S Goudar, M Deepak, B Murali, J Joshua Allan, Amit Agarwal

Article Affiliation:

R&D Centre, Natural Remedies Pvt. Ltd., Plot No. 5B, Veerasandra Indl. Area, 19th K. M. Stone, Hosur Road, Bangalore 560100, India. cvc@naturalremedy.com


Andrographis paniculata is used in the traditional medicine for cold and influenza remedy. The main endeavor in this study was to assess the genotoxicity of the standardized extract of A. paniculata (KalmCold) through three different in vitro tests: Ames, chromosome aberration (CA), and micronucleus (MN). Ames test was performed at 5000 microg/ml, 1581 microg/ml, 500 microg/ml, 158 microg/ml, 50 microg/ml, 16 microg/ml, while the clastogenicity tests were performed at 80 microg/ml, 26.6 microg/ml, 8.8 microg/ml for short-term treatment without S9; 345 microg/ml, 115 microg/ml, 38.3 microg/ml for short-term treatment with S9; and 46 microg/ml, 15.3 microg/ml, 5.1 microg/ml for long-term without S9 using DMSO as a vehicle control. Results of Ames test confirmed that KalmCold did not induce mutations both in the presence and absence of S9 in Salmonella typhimurium mutant strains TA98 and TAMix. In CA and MN, KalmCold did not induce clastogenicity in CHO-K1 cells in vitro. Based on our results, it is evident that KalmCold is genotoxically safe. Additionally in acute oral toxicity study, female rats were treated at 5000 mg/kg of KalmCold and observed for signs of toxicity for 14 days. KalmCold did not produce any treatment-related toxic effects in rats.

Study Type : Review
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