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

Syamsudin Abdillah,Ph.D, Pharm D

Status and phase: Completed; Phase 2

Conditions: Uncomplicated Plasmodium Falciparum

Treatments: Drug: Primaquine; Drug: Momordica Charantia Extract; Drug: Dihydroartemisinin; Drug: Piperaquine

Study type: Interventional

Funder types: Other

Identifiers

NCT05829187

B-056/FI2/KEPK/TL.00/10/2022

Details and patient eligibility

About

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

Full description

The Study was conducted in Kori Primary Health Cender, Sumba Barat Daya District, East Nusa Tenggara Province on Sumba Island.

The study subject received either 3 day of dihydroartemisinin-piperaquine and primaquine 1 day on first day (DHP+PQ) or extract of bitter melon (Momordica charantia/MC) + Placebo 1 day on first day according to their body weight.

Patients with fever or history of fever within the past 24 hours were screened by microscopic examination of giemsa stained tihick blood films to detect Plasmodium falciparum infection.

All Patient were allocated by single blind randomization to receive DHP (on day 0 to day 2)+PQ (on day 0 only) or extract of bitter melon (Momordica charantia/MC) (on day 0 to day 2)+placebo (on day 0 only). The procedures of drug administration in the study were as follows:

Enrollment: 36 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Dihydro artemisinin Piperakuin (Fixed Dose Combination) and Primaquine

Experimental group

Description:

Fixed Dose Combination content in the form of 40 mg dihydroartemisinin and 320 mg piperaquine administered for 3 days with a dose of dihydroartemisinin 2-4 mg/Kg body weight, piperaquine at a dose of 16-32 mg/Kg body weight in the form of a combination set out in the table based on body weight and age. Primaquine dose of 0.25 mg/Kg body weight is given only on the first day. Dihydroartemisinin-piperaquine was local product by PT Mersi Pharmaceuticals, batch No 220610, produced on Jun/22 and expiring on Jun/24. primaquine was local product by PT Phapros Indonesia, Batch No 56386001, produced on Jan/22 and expiring date jan/25.

Treatment:

Drug: Piperaquine

Drug: Dihydroartemisinin

Drug: Primaquine

Extract Capsul Momordica Charantia

Experimental group

Description:

Momordica Charantia 325 mg in 500 mg capsules is given to patients with uncomplicated plasmodium falsiparum malaria as one capsule per day for three days for body weight less than 60 kg. Patients with a body weight of more than 60 kg are given two capsules per day for three days.

Treatment:

Drug: Momordica Charantia Extract