{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,10]],"date-time":"2026-05-10T17:52:37Z","timestamp":1778435557225,"version":"3.51.4"},"reference-count":22,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2020,2,17]],"date-time":"2020-02-17T00:00:00Z","timestamp":1581897600000},"content-version":"vor","delay-in-days":47,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"COPHARBIOTEC Laboratory"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Evidence-Based Complementary and Alternative Medicine"],"published-print":{"date-parts":[[2020,1]]},"abstract":"<jats:p><jats:italic>Background<\/jats:italic>. Considering the promising results of Phase I clinical trials with herbal medicine <jats:italic>CoBaT-Y017<\/jats:italic>, a Phase II study was conducted with <jats:italic>Plasmodium falciparum<\/jats:italic> malaria\u2010infected patients, for efficacy and safety evaluation of <jats:italic>CoBaT-Y017<\/jats:italic> compared with Artemether\u2010Lumefantrine used as a positive control. <jats:italic>Methods<\/jats:italic>. A single\u2010blind randomized trial was conducted on 25 eligible males aged 18\u201340 years randomly assigned to two treatment groups: <jats:italic>CoBaT-Y017<\/jats:italic> or Artemether\u2010Lumefantrine. The first group received 35\u2009ml of <jats:italic>CoBaT-Y017<\/jats:italic> in 1.5\u2009L mineral water administered daily for four consecutive days; the second group received oral Artemether\u2010Lumefantrine, using WHO\u2010recommended therapeutic dose regimens. For both drugs, efficacy for parasite clearance and safety were evaluated clinically, haematologically, and biochemically on days 1\u20134, 7, 14, 21, and 28. Clinical\u2010 and laboratory\u2010adverse events (AEs) were recorded until day 28. <jats:italic>Results<\/jats:italic>. 13 and 12 patients were randomized into <jats:italic>CoBaT-Y017<\/jats:italic> arm and Artemether\u2010Lumefantrine arm, respectively. In all patients, parasitaemia was adequately neutralized with <jats:italic>CoBaT-Y017<\/jats:italic> group patients\u2019 parasite clearance lagging slightly behind that of Artemether\u2010Lumefantrine\u2019s group, but without a statistically significant difference (HR\u2009=\u20091.08, 95% CI 0.47\u20132.51, <jats:italic>P<\/jats:italic> = 0.85). Physical and laboratory examinations did not show any significant changes in vital signs, biochemical, and haematological parameters. In the Artemether\u2010Lumefantrine arm, 100% (12\/12) of patients experienced, at least, one adverse event versus 61.5% (8\/13) in the <jats:italic>CoBaT-Y017<\/jats:italic> arm. <jats:italic>Conclusion<\/jats:italic>. <jats:italic>CoBaT-Y017<\/jats:italic> exhibited similar antimalarial efficacy against <jats:italic>P. falciparum<\/jats:italic> to that of Artemether\u2010Lumefantrine, with good tolerability and safety.<\/jats:p>","DOI":"10.1155\/2020\/8715021","type":"journal-article","created":{"date-parts":[[2020,2,17]],"date-time":"2020-02-17T23:33:17Z","timestamp":1581982397000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["A Phase II Pilot Trial to Evaluate <i>CoBaT-Y017<\/i> Safety and Efficacy against Uncomplicated Falciparum Malaria versus Artemether\u2010Lumefantrine in Benin Subjects"],"prefix":"10.1155","volume":"2020","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8429-803X","authenticated-orcid":false,"given":"Adrien N.","family":"Noudjiegbe","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Femi N.","family":"Alikekere","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Henri","family":"Tchehouenou","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Y\u00e9man","family":"Langa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel S.","family":"Ota","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean-Eudes","family":"Degbelo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aurel C. 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