Malaria Clinical Trial
Official title:
A Pilot, Double-blind, Randomized, Parallel-group, Placebo-controlled, Exploratory Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria
This is a pilot, double-blind, randomized, parallel-group, placebo-control, exploratory study to evaluate the efficacy and safety of 5-aminolevulinic acid hydrochloride (5-ALA HCl) and sodium ferrous citrate (SFC) added on artemisinin-based combination therapy (ACT) compared with ACT alone in the treatment of malaria. Patients who are suffering from uncomplicated malaria, are eligible for randomization.The study will be conducted in a total of 75 patients with uncomplicated malaria.
Approximately 75 patients will be randomized in a 1:2:2 ratio to 3 arms:
Arm 1: placebo+ACT group (15 patients)
Arm 2: 5 ALA/SFC+Placebo+ACT twice daily (BID) (30 patients)
Arm 3: 5-ALA/SFC+Placebo+ACT once daily (QD) (30 patients)
The study duration will be a maximum of 98 days with treatment period of 7 days and follow-up
period of 91 days.
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