ACUTE AND SUB-ACUTE TOXICITY OF UTHULI LWEZICHWE™, A TRADITIONAL MEDICINE USED IN THE MANAGEMENT OF DIABETES MELLITUS IN KWAZULU NATAL, SOUTH AFRICA

Background: The number of people using traditional medicines in the management of chronic diseases is increasing. The safety profile of some of the formulations, however, has not been scientifically demonstrated. This study assessed the acute and sub-acute toxicity of Uthuli Lwezichwe™ (UL), a traditional medicine used by a traditional healer in the management of diabetes mellitus. Materials and Methods: In the acute toxicity assay, one female Sprague dawley rat was administered 1000mg/kg body weight (BW) of Uthuli lwezichwe™ and observed for 14 days. In the sub-acute assay, 24 Sprague dawley rats were randomized into four groups. With one group as the control, the other groups were administered varying daily doses (100 mg, 300 mg, 1000 mg/kg BW) of UL for 28 days. Phytochemical analysis of UL was done using Liquid Chromatography – Quadrupole Time of Flight - Mass Spectrometer (LC-QTOF-MS). Results: There were no significant differences in liver function biomarkers and kidney function biomarkers between the control and all the treatment groups. Histological examination of the kidney however, showed enlarged bowman’s space and distal convoluted tubule diameter and area in the 1000mg/kg UL treated group compared to the control group. Similarly, histological examinations of the liver showed increased sinusoidal space and decreased central vein area in the 1000mg/kg UL treated group. A number of phytoconstituents were identified in UL. Conclusion: The maximum safe dose was determined to be between 300 – 1000 mg/kg BW. We recommend a chronic toxicity study to assess the long-term effects.