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

Abstract

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.

A Phase II Pilot Trial to Evaluate CoBaT-Y017 Safety and Efficacy against Uncomplicated Falciparum Malaria versus Artemether‐Lumefantrine in Benin Subjects

“…is finding supports the clinical information on the most used antimalarial phytomedicines which was ranked CoBaT-Y017 as the leading antimalarial phytomedicine used in Benin for uncomplicated malaria self-treatment and that of the Phase I study [10].…”

“…e second step was a preclinical study evaluating CoBaT-Y017 acute and subacute toxicity. Satisfactorily results obtained led to Phase I study to establish the safety and tolerability of CoBaT-Y017 and providing some indications on the antimalarial efficacy of the drug [10]. e aim of this study, as the third step of our "reverse pharmacology" approach, was a randomized controlled trial to compare the CoBaT-Y017 efficacy and safety with the standard first-line treatment, AL.…”

Evaluación de seguridad del extracto p2et obtenido a partir de caesalpinia spinosa en humanos voluntarios sanos en Colombia

“…Sumado a lo anterior, se reportaron otro tipo de eventos adversos en varios sistemas funcionales en un 48% (20/42) tales como mialgias, astenia, adinamia y síntomas respiratorios (odinofagia, rinofaringitis, tos); asimismo se reportaron en otros estudios clínicos de polifenoles en sujetos sanos con una frecuencia mayor al 30%, eventos adversos dermatológicos 65 y en el sistema nervioso central 56,77 tales como prurito, dermatitis, mareo, cefalea y somnolencia, los cuales parecen ser señales de toxicidad que normalmente no se asocian al este tipo de productos naturales 78,79 . De este modo, existe gran diversidad en los eventos adversos que pueden causar los polifenoles en humanos sanos, lo que quizá está asociado a su vía de administración, duración del consumo y metabolismo propio de cada uno de los polifenoles.…”