Combination Momordica Charantia Extract and Primaquine Againts Plasmodium Falciparum Uncomplicated and Plasmodium Vivax Uncomplicated Treatment in Manokwari, West Papua

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-11

Study Completion Date

2019-04-16

Brief Summary

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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.

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Detailed Description

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Every group therapy session was under team member supervision, required to complete follow-up visits on days 1, 2, 3, 5, 7, 14, 21, 28, 35, and 42. All of the studies 1 and 2 was split into more than two treatment groups, MC+PQ and DHP+PQ. The study was broken up into several 2 studies. Plasmodium falciparum patients without complications (n = 50 in each study) were the subjects of study 1, and Plasmodium vivax patients without complications (n = 50) were the subjects of studies 2 and 3.

The combination of 500 mg of bitter melon fruit extract (Momordica charantia) and 325 mg of bitter melon fruit content (13.50 mg/kg body weight) was initially approved by the MC+PQ group and administered for 3 days. 15 mg Primaquine dose single (0.25 mg/kg body weight) was administered for patients with Plasmodium falciparum and Plasmodium vivax malaria. Patients with Plasmodium falciparum malaria was treated for the first 14 days, while those with Plasmodium vivax malaria were treated for 14 days.

The 2nd DHP+PQ group received three days of DHP (fixed dose combination tablets of 40 mg dihydroartemisinin and 320 mg piperaquine; DHP-FRIMAL, Mersi pharmaceutical, Tbk) in addition to 15 mg primaquine that had previously been given for one day to patients with Plasmodium falciparum who had no complications and for 14 days to those with Plasmodium vivax. DHP renewal is determined by body weight (age 15 years, \>40-60 kg: 3 tablets; \>60-80 kg: 4 tablets; 80 kg: 5 tablets)

Conditions

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Malaria,Falciparum Malaria, Vivax Malaria Infections Uncomplicated Malaria Uncomplicated Plasmodium Falciparum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

the patient comes to the primary health care facility, is examined by a doctor, if malaria is suspected, a parasite examination is carried out in the laboratory. If positive for falciparum malaria and based on the results of the doctor's examination meet the criteria as research subjects, then the drug is given based on the random table that has been provided.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The test drug and the control drug are put into the capsule with the same weight, type and smell so that the patient cannot distinguish between the test drug and the control drug

Study Groups

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bitter melon fruit extract (Momordica charantia) with primaquine

For three days, a combination of 500 mg of bitter melon fruit extract (Momordica charantia) and 325 mg of bitter melon fruit content (13.50 mg/kg body weight) was administered. those with Plasmodium falciparum and Plasmodium vivax malaria received a single dosage of primaquine (0.25 mg/kg body weight) once daily, with those with Plasmodium falciparum malaria receiving it for 14 days.

Group Type EXPERIMENTAL

Primaquine

Intervention Type DRUG

Primaquine dose 0.25 mg/kg body weight given to uncomplicated Plasmodium falciparum patients on the first day only

Momordica Charantia Extract

Intervention Type OTHER

Momordica charantia extract capsules at a dose of 325 mg were given to patients for 3 days

dihydroartemisinin+piperaquine+ primaquine

DHP (fixed dosage combination tablets containing 40 mg dihydroartemisinin and 320 mg piperaquine) was administered to the group for 3 days, with primaquine being administered for 14 days to patients with Plasmodium vivax and 1 day initially to those with Plasmodium falciparum without difficulties. Body weight is taken into consideration while setting therapy parameters (age 15 years, \>40-60 kg: 3 tablets; \>60-80 kg: 4 tablets; 80 kg: 5 tablets).

Group Type ACTIVE_COMPARATOR

Dihydroartemisinin

Intervention Type DRUG

dihidroartemisinin dose of 2-4 mg/Kg Body weight taken for 3 days

Piperaquine

Intervention Type DRUG

piperaquine at a dose of 16-32 mg/Kg body weight taken for 3 days

Primaquine

Intervention Type DRUG

Primaquine dose 0.25 mg/kg body weight given to uncomplicated Plasmodium falciparum patients on the first day only

Interventions

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Dihydroartemisinin

dihidroartemisinin dose of 2-4 mg/Kg Body weight taken for 3 days

Intervention Type DRUG

Piperaquine

piperaquine at a dose of 16-32 mg/Kg body weight taken for 3 days

Intervention Type DRUG

Primaquine

Primaquine dose 0.25 mg/kg body weight given to uncomplicated Plasmodium falciparum patients on the first day only

Intervention Type DRUG

Momordica Charantia Extract

Momordica charantia extract capsules at a dose of 325 mg were given to patients for 3 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* incomplete therapy patients
* Age ≥15 years old male or female up to 60 years old.
* diagnosis and an outcome inspection microscopically suffering from Plasmodium falciparum malaria or Plasmodium vivax with density parasites 1000-100,000/µL
* History of fever within the past 24-48 hours with axillary temperature ≥ 37.5°C
* There were no signs of severe malaria
* had no chronic disease
* willing to follow up for 42 days; No consuming other antimalarial drugs within 2 weeks; willingly to participate in investigations and follow established procedures (informed consent)

Exclusion Criteria

* pregnant female, breastfeeding female, children and infants
* suffering a mental disturbance, heavy illness like kidney, liver, tuberculosis, cancer, AIDS and other heavy diseases
* one set of symptom or signs of severe malaria
* had a history of hypersensitivity, allergies, and antimalarial contraindications
* not willingly to follow the inquiry

Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No