The aim of this study is to evaluate the safety of the use of a phytomedicine syrup (Saratosse®) composed of several medicinal plants: Mikania glomerata, Mentha piperita, Eucalyptus globulus and Copaifera multijuga, along with honey and propolis to treat respiratory diseases. The clinical trial consisted of an open study with 26 adult volunteers of both sexes, who were given an oral dose of 15 mL of Saratosse® for 28 consecutive days, four times a day. Only volunteers who were found healthy after a clinical and physical examination were included. The laboratory tests included: hematological, biochemical and serological analysis. This evaluation was repeated after each week of treatment and seven days after the last administration. ANOVA analysis (Dunnett's test) showed a significant difference, albeit at low statistical level (p < 0.05). Significant differences to the pre-study were not shown by hemoglobin, SGOT, SGPT, creatinine and leukocytes analysis. Laboratorial tests results were within their maximum and minimum reference values. On the whole the medicine was well tolerated. Some side effects were related, which may or not be attributed to the phytomedicine. Clinical, electrocardiographic and laboratory tests did not show any evidence of toxic signs in the organs and systems studied.
Pharmacology; toxicity of drugs; phytotherapy; clinical trials
