CLINICAL TOXICOLOLOGY STUDY OF AN HERVAL MEDICINE OBTAINED FROM THE ETHANOL CRUDE EXTRACT OF THE BARK OF ANACARDIUM OCCIDENTALE LINN, IN HEALTHY VOLUNTEERS

Abstract

The gel extracted from the bark Anacardium occidentale L. is indicated for topical treatment of inflammatory diseases. Objective: The purpose of this study was to evaluate the clinical toxicology of this formulation in healthy volunteers. Material and methods: For this, a non-randomized open clinical trial was conducted with 40 healthy volunteers (22 female and 18 male), who administered the topical gel in their faces during 3 weeks. The volunteers were included in the study only when considered healthy after clinical assessment, physical examination and laboratory tests which preceded the study. The laboratory tests included: hematological, biochemical and serological analysis. The clinical and laboratory evaluation were repeated after the first week and at the end of the third week after the last administration. Results: This gel was well tolerated by the 40 volunteers, and it has showed no adverse events. Conclusion: The clinical and laboratory data assessed before, during and after the test showed no signals of toxicity in various organs and systems evaluated, confirming the safety of the preparation for use in trials of therapeutic efficacy. DESCRIPTORS: Medicinal plants. Acne Vulgaris. Anacardium occidentale