Overview

Momordica Charantia and Dihydroartemisinin-piperaquined-primaquine for Uncomplicated Plasmodium Falciparum Malaria Patients in Southwest Sumba Regency

Status:
Completed
Trial end date:
2022-12-31
Target enrollment:
0
Participant gender:
All
Summary
Currently, the first-line combination of artemisinin, piperaquine and prima-quine is quite effective in controlling malaria, however, the threat of spread of drug-resistant parasites has been reported. A study is conducted to assess the efficacy and safety extract of bitter melon (Momordica charantia/MC) regimens compared to the combination of dihydroartemisinin piperaquine primaquine (DHP+PQ) on the sexual and asexual stage of P. Falciparum uncomplicated in Sumba Barat Daya District, Indonesia
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Syamsudin Abdillah,Ph.D, Pharm D
Treatments:
Artenimol
Piperaquine
Primaquine
Criteria
Inclusion Criteria:-

1. Age ≥ 18 years old male or female up to 60 years old

2. Single Plasmodium falciparum infection based on microscopic examination.

3. Count the parasites for Plasmodium falciparum at least 2 large visual field asexual
parasites (LPB) by examining 15 LPB

4. Density of parasites 1000-100,000/micro liter

5. Has no history of uncontrolled comorbidities

6. History of fever in the last 24 hours for falciparum malaria

7. Not taking other antimalarial drugs in the last 2 weeks.

8. Have no previous history of malaria.

9. Willing to come to the health facility according to the specified follow-up schedule.

10. Willing to participate in research and established procedures.

11. There is no history of allergy to antimalarial drugs.

Exclusion Criteria:

1. Signs of general weakness, or decreased consciousness or recurrent seizures or
circulation failure or pulmonary edema or signs of anemia or yellow body and slightly
red urine.

2. If the examination results show mixed Plasmodium and non-Plasmodium falciparum.

3. Has a history of severe liver, kidney and heart dysfunction, bradycardia and heart
rhythm disturbances.

4. Does not control regularly according to the research schedule

5. Pregnant and lactating women

6. There are signs of severe malaria

7. Patients with chronic diseases, for example: heart, kidney, liver, HIV.

8. Mixed infection.