Background: A number of Traditional Chinese Medicine (TCM) preparations are being used for the treatment of diabetes mellitus. Some components of these preparations have biochemical effects other than those of lowering blood glucose and indeed have been used for other medical indications in traditional practice. The primary objective of the study was to determine the effect of the oral mixture of Traditional Chinese Medicine for diabetes (TCM-D™ complex) on blood glucose level and the biochemical changes if any, on the liver (ALT, AST, gamma-GT, albumin, globulin) and renal (blood creatinine, urea) functions in normal mice. The oral mixture is an aqueous extract of four wellknown traditional Chinese medicinal herbs and consists of Trichosanthes kirilowii Maxim., Paeonia lactiflora Pall., Glycyrrhiza uranlensis Fisch., and Panax ginseng (red) CA Meyer in the proportion of 36%, 28%, 18%, and 18% respectively of the dry weight. These herbs have
been shown to have blood glucose lowering activity and have been used for other traditional medicinal purposes.The safety of the combination was evaluated in the present study. Methods: Experimental Balb/c mice were treated orally via gastric tube with the extract at daily doses equivalent to 1 and 10 times the recommended human dose for 8 weeks. Blood glucose and other biochemical profiles were monitored at pre-treatment and monthly posttreatment until killed. Results: When compared to pre-treatment levels, the blood glucose levels were significantly lower in treated animals compared to those in the control group. At the recommended TCM-D™ dose the levels in treated animals were significantly lower than that of control animals and at pre-treatment. When compared with pre-treatment, the glucose levels were lowest at Week 8 of treatment, the mean levels being 111.23%, 83.32% and 70.33% in control, and in animals given 1 x and 10 x the recommended TCM-D™ dosage respectively. The blood glucose lowering effect was also associated with a significant weight loss in treated animals. There were transient increases in AST and ALT levels but these reverted to normal at Week 8 of treatment. The levels of bilirubin, g-GT, albumin, creatinine and blood urea were also not significantly different at Week 8 from pre-treatment levels in all groups. Conclusion: Even at 10 times the dosage recommended for humans, TCM-D™ did not affect the liver and renal functions of treated animals. Treated and control animals remained healthy and normal throughout the period of observation.