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

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          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.

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          Most cited references13

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          Qinghaosu

          D. L. Hien (1993)
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            A “reverse pharmacology” approach for developing an anti-malarial phytomedicine

            A “reverse pharmacology” approach to developing an anti-malarial phytomedicine was designed and implemented in Mali, resulting in a new standardized herbal anti-malarial after six years of research. The first step was to select a remedy for development, through a retrospective treatment-outcome study. The second step was a dose-escalating clinical trial that showed a dose-response phenomenon and helped select the safest and most efficacious dose. The third step was a randomized controlled trial to compare the phytomedicine to the standard first-line treatment. The last step was to identify active compounds which can be used as markers for standardization and quality control. This example of “reverse pharmacology” shows that a standardized phytomedicine can be developed faster and more cheaply than conventional drugs. Even if both approaches are not fully comparable, their efficiency in terms of public health and their complementarity should be thoroughly considered.
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              Artemisinin resistance on the Thai-Cambodian border.

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                Author and article information

                Contributors
                Journal
                Evid Based Complement Alternat Med
                Evid Based Complement Alternat Med
                ECAM
                Evidence-based Complementary and Alternative Medicine : eCAM
                Hindawi
                1741-427X
                1741-4288
                2019
                21 April 2019
                21 April 2019
                : 2019
                : 7610476
                Affiliations
                1Faculty of Health Sciences, Laboratory of Pharmacology and Toxicology, University of Abomey-Calavi, Benin
                2Beninese Center of Scientific Research and Innovation, National Laboratory of Narcotic and Toxicology, Benin
                3Faculty of Sciences and Technic, Laboratory of Immunology of Infectious diseases and Allergic, University of Abomey-Calavi, Benin
                4Teaching Hospital of Abomey-Calavi/Sô-Ava, Laboratory of Biomedical Analysis, Benin
                5Service of medicine, Teaching Hospital of Abomey-Calavi/Sô-Ava, Benin
                Author notes

                Academic Editor: Juntra Karbwang

                Author information
                http://orcid.org/0000-0002-8429-803X
                Article
                10.1155/2019/7610476
                6500644
                e162a2c1-2045-4034-bb78-44c523929ad3
                Copyright © 2019 Adrien N. Noudjiegbe et al.

                This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 30 January 2019
                : 1 April 2019
                : 14 April 2019
                Categories
                Research Article

                Complementary & Alternative medicine
                Complementary & Alternative medicine

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