Clinical safety evaluation of a phytomedicine containing Mikania glomerata, Grindelia robusta, Copaifera officinalis, Myroxylon toluifera, Nasturtium officinale, honey and propolis in healthy volunteers

Revista Brasileira de Farmacognosia

Nascimento, Demétrius F.¹  Moraes, Manoel O.¹  Carmo, Gardênia C.¹  Quental, Diana P.¹  Moraes, Maria E.A.¹  Universidade Federal do Ceará, Fortaleza, Brasil¹  Bezerra, Fernando A.F.¹  Soares, Aline K.A.¹ 

关键词: Mikania glomerata;    Grindelia robusta;    Copaifera officinalis;    Myroxylon toluifera;    Nasturtium officinale;    toxicology;    phytotherapic.;   

DOI  :  10.1590/S0102-695X2006000400002

来源: Sociedade Brasileira de Farmacognosia

【 摘 要 】

Calmatoss® is a phytomedicine used in several respiratory tract pathologies treatment composed of seven medicinal plants such as Mikania glomerata, Grindelia robusta, Copaifera officinalis, Myroxylon toluifera, Nasturtium officinale, 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 first, 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. In spite of these variations none of the volunteers had their values out of the established normality limits for each parameter. In conclusion, clinical, electrocardiographic and laboratory tests did not show any evidence of toxic signals in the various organs and systems studied.

【 授权许可】

Unknown