Publications Scientifiques

[ Article ] Short-Term Safety and Tolerability of an Antimalarial Herbal Medicine, CoBaT-Y017 in Healthy Volunteers.

Date de soumission: 05-03-2021
Année de Publication: 2019
Entité/Laboratoire Autres laboratoires
Document type : Article
Discipline(s) : Pharmacie, Pharmacologie & Toxicologie
Titre Short-Term Safety and Tolerability of an Antimalarial Herbal Medicine, CoBaT-Y017 in Healthy Volunteers.
Auteurs Noudjiegbe Adrien N. [1], Gnimassou Adeline L. [2], Gbenoudon J. [3], DEGBELO Jean Eude [4], Allabi Aurel C. E. [5],
Journal: Evid Based Complement Alternat Med
Catégorie Journal: Internationale
Impact factor:
Volume Journal: 2019
DOI: 10.1155/2019/7610476
Resume Background: Malaria is the most prevalent parasitic disease in Benin and the main cause of morbidity and mortality. To fight this disease, a large proportion of the population resorts to herbal drugs. However, for most of these herbal preparations, no scientific evidence of their safety or efficacy has yet been established. The aim of this study was to evaluate the short-term safety and tolerability of CoBaT-Y017 and collect some data on its antimalarial efficacy. Material and methods: CoBaT-Y017 was formulated into syrup accommodated in 70 mL bottles. The trial involved a sample of 10 male volunteers, selected using the Lot Quality Assurance Sampling (LQAS) method and declared apparently healthy by a physician through clinical examination. During the baseline analysis, two cases of parasitaemia were detected. The volunteers were hospitalized for 5 days and orally given 35 mL of CoBaT-Y017 diluted in 1.5 L of mineral water, for four consecutive days. Safety and tolerability were monitored clinically, haematologically, biochemically, and parasitologically on days 0 to 5, 7, and 14. Adverse events were recorded by self-reporting or by a physician through clinical examinations and biological investigations. Results: 60% of the volunteers experienced no adverse events; appetite increase (40%) and drowsiness (20%) were adverse events noted. There were no changes in physical characteristics or vital signs and haematological and biochemical parameters. The two initial positive cases of parasitaemia became negative 24 hours after administration. Conclusion: CoBaT-Y017 presented a significant safety and tolerability in healthy volunteers to allow its further development by starting a phase II clinical study.
Mots clés Malaria, Phase I, Healthy volunteers, Paludose*
Pages 1 - 8
Fichier

Publications par entité

  • Centre de Formation et de Recherche en matière de Population (CEFORP) (0)
  • Centre Interfacultaire de Formation et de Recherche en Environnement pour le Développement Durable (CIFRED) (0)
  • Chaire Internationale en Physique Mathématique et Applications (CIPMA-Chaire UNESCO) (0)
  • Ecole Doctorale Pluridisciplinaire <<Espaces, Culture et Développement>> (0)
  • Ecole Nationale d'Administration et de Magistrature (ENAM) (0)
  • Ecole Nationle d'Economie Appliquée et de Management (0)
  • Ecole Normale Supérieure (0)
  • Ecole Polytechnique d'Abomey-Calavi (EPAC) (0)
  • Faculté de droit et de Science Politique (FADESP) (0)
  • Faculté des Lettres et Sciences Humaines (FLASH) (0)
  • Faculté des Lettres, Langues, Arts et Communications (FLLAC) (0)
  • Faculté des Sciences Agronomiques (0)
  • Faculté des Sciences de la Santé (FSS) (0)
  • Faculté des Sciences Economiques et de Gestion (FASEG) (0)
  • Faculté des Sciences et Techniques (FAST) (0)
  • Faculté des Sciences Humaines et Sociales (FASHS) (0)
  • Institut de Formation et de Recherche en Informatique (IFRI) (0)
  • Institut de Géographie de l'Aménagement du territoire et de l'Environnement (IGATE) (0)
  • Institut de Mathématiques et de Sciences Physiques (IMSP) (0)
  • Institut National de l'Eau (INE) (0)
  • INSTITUT NATIONAL DE LA JEUNESSE DE L’EDUCATION PHYSIQUE ET SPORT(INJEPS) (0)
  • Institut National des Métiers d'Art d'Archéologie et de la Culture (INMAAC) (0)
  • Institut National Médico Sanitaire ( INMeS) (0)
  • Institut Régional de Santé Publique (IRSP) (0)

Publications par sexe

  • Femme( 1397 )
  • Homme (