Clinical Toxicity Study of Phythomedicines in Healthy Volunteers

MelparatosseÂ, Calmatoss e Saratosse sÃo produtos fitoterÃpicos, compostos de associaÃÃes de plantas, incorporados a prÃpolis e mel, em forma de xarope, utilizados no tratamento de vÃrias patologias que acometem o trato respiratÃrio. O estudo teve como objetivo avaliar a seguranÃa dessas formulaÃÃes em seres humanos. Esse estudo consistiu de trÃs ensaios clÃnicos abertos, com 26 voluntÃrios saudÃveis de ambos os sexos, com idade variando entre 18 e 49 anos, que receberam, por via oral, quatro doses de 15mL de um dos trÃs fitoterÃpicos, durante 21 dias ininterruptos; 28 dias, no caso do SaratosseÂ. Os voluntÃrios foram incluÃdos no estudo somente quando considerados saudÃveis, apÃs avaliaÃÃo clÃnica, exame fÃsico e exames laboratoriais que antecederam o estudo. A avaliaÃÃo laboratorial incluÃa: anÃlises hematolÃgicas, bioquÃmicas e sorolÃgicas. Essa mesma avaliaÃÃo foi repetida ao tÃrmino de cada semana de tratamento e no pÃs-estudo, sete dias apÃs a Ãltima administraÃÃo. Os exames clÃnicos, eletrocardiogrÃfico e laboratoriais nÃo evidenciaram sinais de toxicidade nos diversos ÃrgÃos e sistemas avaliados. Os eventos adversos relatados nos trÃs estudos foram: palpitaÃÃo, dispnÃia, astenia, tosse, tontura, aumento de transaminases, disÃria, mialgia, constipaÃÃo (n=1); pirose, flatulÃncia, dismenorrÃia, odontalgia, mal-estar (n=2); nÃusea, enxaqueca, sonolÃncia (n=3); diarrÃia, epigastralgia, dor abdominal (n=4); cefalÃia (n=9); gripe (n=9); faringite (n=11). Esses eventos foram classificados como possivelmente ou nÃo atribuÃdos aos fitoterÃpicos. Os xaropes MelparatosseÂ, Calmatoss e Saratosse foram bem tolerados pelos voluntÃrios.MelparatosseÂ, Calmatoss e Saratosse are phytomedicine products used for the treatment of several pulmonary diseases. Their compositions include medicinal plants, as well as honey and propolis, as syrups. The study aimed to assay these formulations for their safe use in humans. It consisted of three open clinical trials with 26 healthy volunteers of both sexes each one. The vontunteers age ranged from 18 to 49 years old and they received an oral dose of 15 mL of one of these three products for uninterrupted 21 days- except SaratosseÂ, 28 days -, four times a day. To get in to the trials, the volunteers had to be considered as healthy after clinical evaluation, physical examination and laboratory tests. The laboratory tests included hematological, biochemical and serological analysis. This evaluation was repeated at the end of every week of treatment, and seven days after the last administration. Clinical, electrocardiographic and laboratory tests did not show any evidence of toxic signs in the various organs and systems studied. Adverse events related at the studies were: tachycardia, dyspnea, asthenia, cough, dizziness, increase of transaminase, dysuria, muscle pain, constipation (n=1); pyrosis, flatulence, dysmenorrhea, dental pain, malaise (n=2); nausea, migraine, drowsiness (n=3); diarrhea, epigastralgy, abdominal pain (n=4); headache (n=9); flu (n=9); pharyngitis (n=11). All the events were classified as possible or not related to the phytomedicines assayed. Those events were well tolerated by all volunteers