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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 , 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 , a Phase II study was conducted with  Plasmodium falciparum  malaria-infected patients, for efficacy and safety evaluation of  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 , a Phase II study was conducted with  Plasmodium falciparum  malaria-infected patients, for efficacy and safety evaluation of  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 , 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 , 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. P. falciparum

evidence-based complementary and alternative medicine

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

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