Phase I clinical toxicological assays of a complex herbal medicine (Schinus terebinthifolius Raddi, Plectranthus amboinicus Lour and Eucaliptus globulus Labill)

Abstract

In this study, phase I clinical toxicological assays of the herbal medicine composed of the medicinal plants Schinus terebinthifolius Raddi, Plectranthus amboinicus Lour and Eucaliptus globulus Labill were performed. The study was carried out at Hospital Universitário Lauro Wanderley/UFPB/PB/Brazil and for this purpose, 28 healthy volunteers were chosen, 14 men and 14 women who ingested 15 mL of the medicine per oral, with no interruption, three times a day; and on the 3rd and 7th days, on the 3rd and 6th weeks and 24h after the 8th week, clinical and laboratory evaluations were performed to analyze the acute and chronic toxicity. As results, the patients did not show significant clinical and laboratory alterations and adverse reactions, only little alterations were detected in blood through aspartate transaminase (AST) and alkaline phosphatase in the female group to a p < 0.05; however, these values are according to the normality standard for adult individuals. It can be concluded that these data, complementary to those obtained with the preclinical studies, confirm the low toxicity of the herbal medicine.