Combination Momordica Charantia Extract and Primaquine Againts Plasmodium Falciparum Uncomplicated and Plasmodium Vivax Uncomplicated Treatment in Manokwari, West Papua
NCT06036030 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2023-09-13
Summary
Comparing the efficacy of the combination treatment of bitter melon fruit extract (Momordica charantia) with primaquine (MC+PQ) against the combination of dihydroartemisinin + piperaquine + primaquine (DHP+PQ) on patients with Plasmodium falciparum and Plasmodium vivax without complications in Manokwari, West Papua, Indonesia. The research was conducted from January 2019 to April 2019 at Manokwari Regional General Hospital, West Papua. Open label, 2 parallel randomized clinical studies with Plasmodium falciparum malaria patients without complications (Study 1) and patients with Plasmodium vivax malaria without complications (Study 2). The randomized clinical trial divided in 2 treatment groups, namely the MC+PQ and DHP+PQ. The Success of the treatment was determined by the combination of blood schizontocidal therapy in radical cure. The overall final assessed results were the average value of parasitological failure, hematological measurements, liver function, kidney function, blood lipid levels, blood glucose levels and adverse events until day 42.
Conditions
- Malaria,Falciparum
- Malaria, Vivax
- Malaria
- Infections
- Uncomplicated Malaria
- Uncomplicated Plasmodium Falciparum
Interventions
- DRUG
-
Dihydroartemisinin
dihidroartemisinin dose of 2-4 mg/Kg Body weight taken for 3 days
- DRUG
-
Piperaquine
piperaquine at a dose of 16-32 mg/Kg body weight taken for 3 days
- DRUG
-
Primaquine
Primaquine dose 0.25 mg/kg body weight given to uncomplicated Plasmodium falciparum patients on the first day only
- OTHER
-
Momordica Charantia Extract
Momordica charantia extract capsules at a dose of 325 mg were given to patients for 3 days
Sponsors & Collaborators
-
Dr Cipto Mangunkusumo General Hospital
collaborator OTHER -
PT Natura Nuswantara Nirmala
collaborator UNKNOWN -
Syamsudin Abdillah,Ph.D, Pharm D
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 15 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-11
- Primary Completion
- 2019-04-16
- Completion
- 2019-04-16
Countries
- Indonesia
Study Locations
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