Acute Toxicity Study of the Crude Aqueous Extract of Tribulus terrestris Dried Fruit with Potential Diuretic Effect

Introduction: Tribulus terrestris is an important medicinal plant used in Indian traditional medicine, the crude aqueous extract of the plant is primarily used to induce diuresis for treating cardiovascular diseases and managing renal stones, etc... The safe dose and adverse effect profile of the extract was not explored adequately in preclinical studies. Hence, the present study was undertaken. Methods: The acute toxicity was assessed based on the OECD guideline number 425: Acute Oral Toxicity – Up-and-Down-Procedure. A total of 11 animals were used in the study. Initially, one animal was administered with a dosage of 2000 mg/kg; and as the animal survived, four more animals were dosed and were observed for survival and other possible adverse drug reactions. The animals' body weight was measured before experimenting and at the end of the study. Biochemical and haematological examinations were done on normal control and test groups. Animals from the test group were sacrificed, and histopathological examinations of the vital organs were carried out. Results: No signs of toxicity or changes in the behaviour were observed in the treatment group. As all the animals survived, it was decided that the LD₅₀ was greater than 2000 mg/kg. However, the changes observed with platelets, total cholesterol and LDL were within the normal limits. Histological examination of the vital organs did not reveal any changes in the architecture of the organs. Conclusion: Our study demonstrated that the crude aqueous extract of Tribulus terrestris dried fruit does not cause toxicity under the 2000 mg/kg dose limit.