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

BACKGROUND

Considering the promising results of Phase I clinical trials with herbal medicine , a Phase II study was conducted with malaria-infected patients, for efficacy and safety evaluation of , a Phase II study was conducted with malaria-infected patients, for efficacy and safety evaluation of 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: , a Phase II study was conducted with malaria-infected patients, for efficacy and safety evaluation of , a Phase II study was conducted with malaria-infected patients, for efficacy and safety evaluation of compared with Artemether-Lumefantrine used as a positive control. . A single-blind randomized trial was conducted on 25 eligible males aged 18-40 years randomly assigned to two treatment groups: or Artemether-Lumefantrine. The first group received 35 ml of 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 , a Phase II study was conducted with malaria-infected patients, for efficacy and safety evaluation of , a Phase II study was conducted with malaria-infected patients, for efficacy and safety evaluation of compared with Artemether-Lumefantrine used as a positive control. . A single-blind randomized trial was conducted on 25 eligible males aged 18-40 years randomly assigned to two treatment groups: or Artemether-Lumefantrine. The first group received 35 ml of 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. . 13 and 12 patients were randomized into arm and Artemether-Lumefantrine arm, respectively. In all patients, parasitaemia was adequately neutralized with 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, =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 , a Phase II study was conducted with malaria-infected patients, for efficacy and safety evaluation of compared with Artemether-Lumefantrine used as a positive control. . A single-blind randomized trial was conducted on 25 eligible males aged 18-40 years randomly assigned to two treatment groups: or Artemether-Lumefantrine. The first group received 35 ml of 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. . 13 and 12 patients were randomized into arm and Artemether-Lumefantrine arm, respectively. In all patients, parasitaemia was adequately neutralized with 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, =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 arm.

CONCLUSION

, a Phase II study was conducted with malaria-infected patients, for efficacy and safety evaluation of compared with Artemether-Lumefantrine used as a positive control. . A single-blind randomized trial was conducted on 25 eligible males aged 18-40 years randomly assigned to two treatment groups: or Artemether-Lumefantrine. The first group received 35 ml of 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. . 13 and 12 patients were randomized into arm and Artemether-Lumefantrine arm, respectively. In all patients, parasitaemia was adequately neutralized with 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, =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 arm. . exhibited similar antimalarial efficacy against to that of Artemether-Lumefantrine, with good tolerability and safety..