NCT06036030

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2019

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

September 4, 2023

Last Update Submit

September 11, 2023

Conditions

Malaria,FalciparumMalaria, VivaxMalariaInfectionsUncomplicated MalariaUncomplicated Plasmodium Falciparum

Keywords

Momordica charantiaprimaquinecombination therapy dihydroartemisininPlasmodium falciparumPlasmodium vivax

Outcome Measures

Primary Outcomes (1)

  • development of sexual and asexual stages of Plasmodium falciparum

    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

    0, 14, 28, and 42 days post-treatment

Secondary Outcomes (2)

  • Parasite clearence times

    0, 14, 28, and 42 days post-treatment

  • Fever clearance time

    0, 14, 28, and 42 days post-treatment

Other Outcomes (16)

  • Hemoglobin measurement

    0, 14, 28, and 42 days post-treatment

  • Erytrocytes measurement

    0, 14, 28, and 42 days post-treatment

  • Hematocrits measurement

    0, 14, 28, and 42 days post-treatment

  • +13 more other outcomes

Study Arms (2)

bitter melon fruit extract (Momordica charantia) with primaquine

EXPERIMENTAL

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: PrimaquineOther: Momordica Charantia Extract

dihydroartemisinin+piperaquine+ primaquine

ACTIVE COMPARATOR

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: DihydroartemisininDrug: PiperaquineDrug: Primaquine

Interventions

DihydroartemisininDRUG

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

dihydroartemisinin+piperaquine+ primaquine
PiperaquineDRUG

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

dihydroartemisinin+piperaquine+ primaquine
PrimaquineDRUG

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

bitter melon fruit extract (Momordica charantia) with primaquinedihydroartemisinin+piperaquine+ primaquine
Momordica Charantia ExtractOTHER

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

bitter melon fruit extract (Momordica charantia) with primaquine

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manokwari Regional General Hospital

Manokwari, West Papua, Indonesia

Location

Related Publications (5)

  • Abdillah S, Tambunan RM, Sinaga YM, Farida Y. Ethno-botanical survey of plants used in the traditional treatment of malaria in Sei Kepayang, Asahan of North Sumatera. Asian Pac J Trop Med. 2014 Sep;7S1:S104-7. doi: 10.1016/S1995-7645(14)60213-3.

    PMID: 25312101BACKGROUND

  • Jia S, Shen M, Zhang F, Xie J. Recent Advances in Momordica charantia: Functional Components and Biological Activities. Int J Mol Sci. 2017 Nov 28;18(12):2555. doi: 10.3390/ijms18122555.

    PMID: 29182587BACKGROUND

  • Chen F, Huang G, Yang Z, Hou Y. Antioxidant activity of Momordica charantia polysaccharide and its derivatives. Int J Biol Macromol. 2019 Oct 1;138:673-680. doi: 10.1016/j.ijbiomac.2019.07.129. Epub 2019 Jul 22.

    PMID: 31344411BACKGROUND

  • Wang S, Liu Q, Zeng T, Zhan J, Zhao H, Ho CT, Xiao Y, Li S. Immunomodulatory effects and associated mechanisms of Momordica charantia and its phytochemicals. Food Funct. 2022 Nov 28;13(23):11986-11998. doi: 10.1039/d2fo02096c.

    PMID: 36350105BACKGROUND

  • Nelwan EJ, Ekawati LL, Tjahjono B, Setiabudy R, Sutanto I, Chand K, Ekasari T, Djoko D, Basri H, Taylor WR, Duparc S, Subekti D, Elyazar I, Noviyanti R, Sudoyo H, Baird JK. Randomized trial of primaquine hypnozoitocidal efficacy when administered with artemisinin-combined blood schizontocides for radical cure of Plasmodium vivax in Indonesia. BMC Med. 2015 Dec 11;13:294. doi: 10.1186/s12916-015-0535-9.

    PMID: 26654101RESULT

MeSH Terms

Conditions

Malaria, FalciparumMalaria, VivaxMalariaInfections

Interventions

artenimolpiperaquinePrimaquinebitter melon extract

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Profesor Dr Syamsudin Abdillah, M.Biomed

Study Record Dates

First Submitted

September 4, 2023

First Posted

September 13, 2023

Study Start

January 11, 2019

Primary Completion

April 16, 2019

Study Completion

April 16, 2019

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
1 year
Access Criteria
Sharing Access are only for research purposes.

Locations

ID(1)