Toxicity studies on herbal formulation used in diabetes mellitus.

In current study herbal formulation was prepared for Diabetes mellitus (type 2). It consists of the extracts of Salacia reticulate, Cinnamomum zeylanicum,Lagerstroemia speciosa, Camellia sinensis and Gymnema sylvester. Toxicitystudies were carried out on heart, liver, kidney and blood of both male and female rabbits. Drug was administered in a dose of 15mg/kg body weight daily for 90 days. On 91th day, blood was drawn from animals and investigated for changes in biochemical and hematological levels. After that animals were sacrificed and their organs (liver, heart and kidney) were analyzed for histo-pathological changes. In biochemical tests for lipid profile, significant decreased (male-70.64 ± 0.321; female-69.80 ± 0.365) in triglycerides level were observed, no significant change was recorded in Cholesterol HDL ratio, LDL, VLDL level. A significant increase (male-16.00 ± 1.418; female-10.00 ± 0.709) was observed in HDL level. In liver function test significant decrease was observed in Gamma GT (male-10.08 ± 0.862; female-7.00 ± 0.709). Alkaline phosphatase (male-79 ± 0.838; female-51.1 ± 1.810), SGPT (male-54 ± 0.709; female-43.04 ± 2.060), direct bilirubin (male-0.024 ± 0.005; female-0.014 ± 0.002) and total bilirubin (male-0.109 ± 0.003; 0.106 ± 0.049) were observed. Non-significant changes were observed in serum total protein, globulins, albumin and A/G ratio. No significant changes were noticed in urea level and serum electrolytes. In cardiac enzymes significant decrease was observed in LDH (male-443 ± 5.61; female-360 ± 1.848) and SGOT (male-27 ± 0.709; female-28 ± 1.418) level and highly significant rise in CPK (male- 3128 ± 8.478; female-1598 ± 7.483) and CK-MB (male-446 ± 2.308; female-438 ± 2.819). In hematological profile, significant decrease was observed in Hb (male-12.3 ± 0.392; female-12.4 ± 0.1), RBC count (male-6.60 ± 0.167; female-5.74 ± 0.25) and Hematocrit (HCT/PCV) % in both male and female rabbits (male-45.70 ± 0.255; female-43.50 ± 0.448) and significant (p<0.5) increased in WBC count (male-8.40 ± 0.401; female-9.10 ± 0.054). Significant (p<0.5) decrease in blood glucose level and HbA1c (male-3.36 ± 0.113; female-3.16 ± 0.076) was observed. In histopathological studies mild edema was observed in heart and there was no change in histo-architecture of liver and kidneys. It is concluded that formulation does not showed any chronic toxicity in adult dose.