Estudo de toxicologia clínica de um fitoterápico contendo Passiflora incarnata L., Crataegus oxyacantha L., Salix alba L. em voluntários saudávei

Abstract

“Clinical toxicology study of an herbal medicine with Passiflora incarnata L., Crataegus oxyacantha L., Salix alba L. in healthy volunteers”. Pasalix® is an herbal medicine containing a combination of three medicinal plants: Passiflora incarnata, Salix alba and Crataegus oxyacantha . Its main indication is to treat anxiety and insomnia. The purpose of this study was to evaluate the clinical toxicology of that formulation in healthy volunteers. For this, a non- randomized open clinical trial was conducted with 24 healthy male volunteers, who received two (2) coated tablets of the herbal medicine twice a day for 28 uninterrupted days. 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 was repeated after the 1 st , 2 nd , 3 rd and 4 th weeks of the treatment and 7 days after the last administration. Pasalix® was well tolerated by the 24 volunteers, and it has showed no serious adverse events. The clinical, laboratory, and electrocardiographic 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.