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Completed

NCT Number: NCT06036030

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

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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Key information

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Manokwari Regional General Hospital

Manokwari, West Papua, Indonesia

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dihydroartemisinin

Drug

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

Piperaquine

Drug

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

Primaquine

Drug

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

Momordica Charantia Extract

Other

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

Primary outcomes

  1. development of sexual and asexual stages of Plasmodium falciparum

    Time frame: 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 outcomes

  1. Parasite clearence times

    Time frame: 0, 14, 28, and 42 days post-treatment

    parasite reduction ratio

  2. Fever clearance time

    Time frame: 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 outcomes

  1. Hemoglobin measurement

    Time frame: 0, 14, 28, and 42 days post-treatment

    Hematological study, measure in g/dl

  2. Erytrocytes measurement

    Time frame: 0, 14, 28, and 42 days post-treatment

    Hematological study, measure in 10^6/mm³

  3. Hematocrits measurement

    Time frame: 0, 14, 28, and 42 days post-treatment

    Hematological study, measure in %

  4. Thrombocytes measurement

    Time frame: 0, 14, 28, and 42 days post-treatment

    Hematological study, measure in 10^3/mm³

  5. Leucocytes measurement

    Time frame: 0, 14, 28, and 42 days post-treatment

    Hematological study, measure count in 1 µL

  6. Albumin measurement

    Time frame: 0, 14, 28, and 42 days post-treatment

    Hematological study, measure in mg%

  7. AST/SGOT measurement

    Time frame: 0, 14, 28, and 42 days post-treatment

    Blood chemistry, measure in µ/mL

  8. total bilirubin measurement

    Time frame: 0, 14, 28, and 42 days post-treatment

    Blood chemistry, measure in mg %

  9. Direct bilirubin measurement

    Time frame: 0, 14, 28, and 42 days post-treatment

    Blood chemistry, measure in mg %

  10. Total protein measurement

    Time frame: 0, 14, 28, and 42 days post-treatment

    Blood chemistry, measure in mg %

  11. Creatinine measurement

    Time frame: 0, 14, 28, and 42 days post-treatment

    Blood chemistry, measure in mg %

  12. Ureum measurement

    Time frame: 0, 14, 28, and 42 days post-treatment

    Blood chemistry, measure in mg %

  13. Gout measurement

    Time frame: 0, 14, 28, and 42 days post-treatment

    Blood chemistry, measure in mg %

  14. Total Cholesterol measurement

    Time frame: 0, 14, 28, and 42 days post-treatment

    Lipid parameter, measure in mg/dL

  15. Triglycerides measurement

    Time frame: 0, 14, 28, and 42 days post-treatment

    Lipid parameter, measure in mg/dL

  16. Glucose measurement

    Time frame: 0, 14, 28, and 42 days post-treatment

    Glucose parameter, measure in mg/dL

Sponsors and collaborators

Lead sponsor

Syamsudin Abdillah,Ph.D, Pharm D

Other

Collaborators

  • Dr Cipto Mangunkusumo General Hospital
  • PT Natura Nuswantara Nirmala

Registry information

Acronym: MCMPFPB

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 13, 2023
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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