A Phase II Pilot Trial to Evaluate CoBaT-Y017 Safety and Efficacy against Uncomplicated Falciparum Malaria versus Artemether-Lumefantrine in Benin Subjects
Joint Authors
Noudjiegbe, Adrien N.
Degbelo, Jean-Eudes
Allabi, Aurel C. E.
Alikekere, Femi N.
Tchehouenou, Henri
Langa, Yéman
Ota, Daniel S.
Source
Evidence-Based Complementary and Alternative Medicine
Issue
Vol. 2020, Issue 2020 (31 Dec. 2020), pp.1-9, 9 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2020-02-17
Country of Publication
Egypt
No. of Pages
9
Main Subjects
Abstract EN
Background.
Considering the promising results of Phase I clinical trials with herbal medicine CoBaT-Y017, a Phase II study was conducted with Plasmodium falciparum malaria-infected patients, for efficacy and safety evaluation of CoBaT-Y017 compared with Artemether-Lumefantrine used as a positive control.
Methods.
A single-blind randomized trial was conducted on 25 eligible males aged 18–40 years randomly assigned to two treatment groups: CoBaT-Y017 or Artemether-Lumefantrine.
The first group received 35 ml of CoBaT-Y017 in 1.5 L mineral water administered daily for four consecutive days; the second group received oral Artemether-Lumefantrine, using WHO-recommended therapeutic dose regimens.
For both drugs, efficacy for parasite clearance and safety were evaluated clinically, haematologically, and biochemically on days 1–4, 7, 14, 21, and 28.
Clinical- and laboratory-adverse events (AEs) were recorded until day 28.
Results.
13 and 12 patients were randomized into CoBaT-Y017 arm and Artemether-Lumefantrine arm, respectively.
In all patients, parasitaemia was adequately neutralized with CoBaT-Y017 group patients’ parasite clearance lagging slightly behind that of Artemether-Lumefantrine’s group, but without a statistically significant difference (HR = 1.08, 95% CI 0.47–2.51, P=0.85).
Physical and laboratory examinations did not show any significant changes in vital signs, biochemical, and haematological parameters.
In the Artemether-Lumefantrine arm, 100% (12/12) of patients experienced, at least, one adverse event versus 61.5% (8/13) in the CoBaT-Y017 arm.
Conclusion.
CoBaT-Y017 exhibited similar antimalarial efficacy against P.
falciparum to that of Artemether-Lumefantrine, with good tolerability and safety.
American Psychological Association (APA)
Noudjiegbe, Adrien N.& Alikekere, Femi N.& Tchehouenou, Henri& Langa, Yéman& Ota, Daniel S.& Degbelo, Jean-Eudes…[et al.]. 2020. A Phase II Pilot Trial to Evaluate CoBaT-Y017 Safety and Efficacy against Uncomplicated Falciparum Malaria versus Artemether-Lumefantrine in Benin Subjects. Evidence-Based Complementary and Alternative Medicine،Vol. 2020, no. 2020, pp.1-9.
https://search.emarefa.net/detail/BIM-1157871
Modern Language Association (MLA)
Noudjiegbe, Adrien N.…[et al.]. A Phase II Pilot Trial to Evaluate CoBaT-Y017 Safety and Efficacy against Uncomplicated Falciparum Malaria versus Artemether-Lumefantrine in Benin Subjects. Evidence-Based Complementary and Alternative Medicine No. 2020 (2020), pp.1-9.
https://search.emarefa.net/detail/BIM-1157871
American Medical Association (AMA)
Noudjiegbe, Adrien N.& Alikekere, Femi N.& Tchehouenou, Henri& Langa, Yéman& Ota, Daniel S.& Degbelo, Jean-Eudes…[et al.]. A Phase II Pilot Trial to Evaluate CoBaT-Y017 Safety and Efficacy against Uncomplicated Falciparum Malaria versus Artemether-Lumefantrine in Benin Subjects. Evidence-Based Complementary and Alternative Medicine. 2020. Vol. 2020, no. 2020, pp.1-9.
https://search.emarefa.net/detail/BIM-1157871
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1157871