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

Sponsor

Syamsudin Abdillah,Ph.D, Pharm D (Other)

Overall Status

Completed

CT.gov ID

NCT06036030

Collaborator

Cipto Mangunkusumo Hospital (Other), PT Natura Nuswantara Nirmala (Other)

Enrollment

Location

Arms

3.1

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Malaria,Falciparum Malaria, Vivax Malaria Infections Uncomplicated Malaria Uncomplicated Plasmodium Falciparum	Drug: Dihydroartemisinin Drug: Piperaquine Drug: Primaquine Other: Momordica Charantia Extract	Phase 2

Detailed Description

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)

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 11, 2019

Actual Primary Completion Date :

Apr 16, 2019

Actual Study Completion Date :

Apr 16, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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
Active Comparator: 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).	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

Arm

Intervention/Treatment

Experimental: 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.

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

Active Comparator: 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).

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

Outcome Measures

Primary Outcome Measures

development of sexual and asexual stages of Plasmodium falciparum [0, 14, 28, and 42 days post-treatment]
Finger prick blood samples are collected for malaria blood smear. Thick and thin blood smear were stained with 3% giemsa solution for 45 minutes and were read under binocular microscope with 1,000x magnification

Secondary Outcome Measures

Parasite clearence times [0, 14, 28, and 42 days post-treatment]
parasite reduction ratio
Fever clearance time [0, 14, 28, and 42 days post-treatment]
time taken for the axilla temperature to fall below 37.5°C in patients who were febrile at inclusion

Other Outcome Measures

Hemoglobin measurement [0, 14, 28, and 42 days post-treatment]
Hematological study, measure in g/dl
Erytrocytes measurement [0, 14, 28, and 42 days post-treatment]
Hematological study, measure in 10^6/mm³
Hematocrits measurement [0, 14, 28, and 42 days post-treatment]
Hematological study, measure in %
Thrombocytes measurement [0, 14, 28, and 42 days post-treatment]
Hematological study, measure in 10^3/mm³
Leucocytes measurement [0, 14, 28, and 42 days post-treatment]
Hematological study, measure count in 1 µL
Albumin measurement [0, 14, 28, and 42 days post-treatment]
Hematological study, measure in mg%
AST/SGOT measurement [0, 14, 28, and 42 days post-treatment]
Blood chemistry, measure in µ/mL
total bilirubin measurement [0, 14, 28, and 42 days post-treatment]
Blood chemistry, measure in mg %
Direct bilirubin measurement [0, 14, 28, and 42 days post-treatment]
Blood chemistry, measure in mg %
Total protein measurement [0, 14, 28, and 42 days post-treatment]
Blood chemistry, measure in mg %
Creatinine measurement [0, 14, 28, and 42 days post-treatment]
Blood chemistry, measure in mg %
Ureum measurement [0, 14, 28, and 42 days post-treatment]
Blood chemistry, measure in mg %
Gout measurement [0, 14, 28, and 42 days post-treatment]
Blood chemistry, measure in mg %
Total Cholesterol measurement [0, 14, 28, and 42 days post-treatment]
Lipid parameter, measure in mg/dL
Triglycerides measurement [0, 14, 28, and 42 days post-treatment]
Lipid parameter, measure in mg/dL
Glucose measurement [0, 14, 28, and 42 days post-treatment]
Glucose parameter, measure in mg/dL

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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