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Avaliação da segurança clínica de um fi toterápico contendo Mikania glomerata, Grindelia robusta, Copaifera offi cinalis, Myroxylon toluifera, Nasturtium offi cinale, própolis e mel em voluntários saudáveis ABSTRACT: "Clinical safety evaluation of a phytomedicine containing Mikania glomerata, Grindelia robusta, Copaifera offi cinalis, Myroxylon toluifera, Nasturtium offi cinale, honey and propolis in healthy volunteers". Calmatoss® is a phytomedicine used in several respiratory tract pathologies treatment composed of seven medicinal plants such as Mikania glomerata, Grindelia robusta, Copaifera offi cinalis, Myroxylon toluifera, Nasturtium offi cinale, as well as honey and propolis. The present study investigated the chronic administration of 15 mL Calmatoss® syroup four times a day during 21 days for any toxic effect on healthy volunteers. The clinical trial consisted of an open study with 24 volunteers included in the study only when considered healthy after clinical evaluation, physical examination and laboratory tests, which preceded the study. The laboratory tests included: heamatologic, biochemical and sorologic analysis. This evaluation was repeated after the fi rst, second and third week of treatment and at post-study seven days after the last administration. Calmatoss® was well tolerated by the volunteers. Variations in the laboratory were observed and all of these laboratory changes returned to normal levels during or after the study. Cañigueral; Vila, 1998, Mills;Bone, 2000). De acordo com Alonso (1998) o Bálsamo de Tolú, Myroxylon toluifera ou Toluifera balsamum é originário da América do Sul (Venezuela, Colômbia e Peru). A oleoresina extraída do tronco mediante cortes em "V" é rica em substâncias com propriedades antisépticas expectorantes (Boyd, 1954, Melo;Melo 2005), espasmolíticas, cicatrizantes e antiparasitárias (Alonso, 1998). É empregado topicamente no tratamento de sarnas, feridas e úlceras dérmicas (Cañigueral;Vila, 1998) Albumina (g/dL) 4,09 ± 0,2 4,09 ± 0,2 4,3 ± 0,2 4,3 ± 0,2 ALT (U/L) 22,4 ± 13,5 18,5 ± 10,7 20,9 ± 11,4 18,6 ± 13,2 AST (U/L) 23,67 ± 8,63 20,8 ± 5,4 22,3 ± 6,5 17,4 ± 4,5 Bilirrubina (mg/dL) 0 15,6 ± 20,7 Glicemia (mg/dL) 82,9 ± 8,5 82,3 ± 10,8 84,9 ± 6,2 87,3 ± 8,1 Hematócrito (%) 40,61 ± 3,1 40,22 ± 2,9 42,83 ± 2,9 42,6 ± 3,9 Hemoglobina (g/dL)13,8 ± 1,3 13,4 ± 1,2 14,7 ± 1,0 14,3 ± 1,1 Leucócitos (cels/mm 3 ) 7,1 ± 1,3 7,2 ± 0,8 6,5 ± 1,5 6,2 ± 1,4 Plaquetas (cels/mm 3 ) 272,3 ± 6,0 299,6 ± 55,5 242,7 ± 28,7 237,4 ± 32,6 Potássio (Mmol/L) 4,1 ± 0,3 4,2 ± 0,2 4,3 ± 0,4 4,2 ± 0,2 Proteína total 7,4 ± 0,4 7,3 ± 0,3 7,4 ± 0,3 7,2 ± 0,3 Sódio (Mmol/L) 138,8 ± 2,6 138,8 ± 1,0 140,4 ± 1,9 138,8 ± 3,2 TP 1,1 ± 0,1 1,2 ± 0,1 1,2 ± 0,1 1,1 ± 0,1 TPTA (%) 1,0 ± 0,1 1,0 ± 0,1 1,0 ± 0,1 1,0

ArtigoEstudo de toxicologia clínica de um fitoterápico contendo Passiflora incarnata L., Crataegus oxyacantha L., Salix alba L. em voluntários saudáveis 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 nonrandomized 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.

Research has demonstrated the need for identifying a novel antimicrobial agent for topical use in the pediatric dental population. The essential oil of Lippia sidoides Cham. (LSO) has been described as having favorable biological properties, and a broad in vitro and in vivo antimicrobial spectrum against bacteria and yeast infections. Our aim was to determine a dose and formulation of LSO, acceptable for clinical testing in a pediatric population with dental caries. Thirty-seven 6-12-year old children were selected to participate in this study, and randomly allocated to receive different concentrations of either a gel (0.8%, 1%, 1.2% and 1.4%) or a mouth rinse (0.6%, 0.8%, 1% and 1.2%) formulation. The highest percentage MS reduction was observed with 0.8% mouth rinse and 1.4% gel. The efficacy of these concentrations was compared with a Thy-Car mixture formulated as a mouth rinse and gel treatments in 11 children. Saliva was collected after a single application of the antimicrobial treatment to establish effectiveness against MS. Both rinse (p<0.001) and gel (p=0.02) formulations produced significant MS reduction. Mouth rinse concentrations above 0.8% were associated with a transient intra-oral burning sensation. In conclusion, mouth rinse and gel LSO formulations demonstrated effectiveness against MS and good acceptance among children. We suggest future randomized clinical trials to test its effectiveness against early childhood caries.

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