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

Primary Purpose

Malaria,Falciparum, Malaria, Vivax, Malaria

Status
Completed
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
Dihydroartemisinin
Piperaquine
Primaquine
Momordica Charantia Extract
Sponsored by
Syamsudin Abdillah,Ph.D, Pharm D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria,Falciparum focused on measuring Momordica charantia, primaquine, combination therapy dihydroartemisinin, Plasmodium falciparum, Plasmodium vivax

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Manokwari Regional General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

bitter melon fruit extract (Momordica charantia) with primaquine

dihydroartemisinin+piperaquine+ primaquine

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Parasite clearence times
parasite reduction ratio
Fever clearance time
time taken for the axilla temperature to fall below 37.5°C in patients who were febrile at inclusion

Full Information

First Posted
September 4, 2023
Last Updated
September 11, 2023
Sponsor
Syamsudin Abdillah,Ph.D, Pharm D
Collaborators
Cipto Mangunkusumo Hospital, PT Natura Nuswantara Nirmala
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1. Study Identification

Unique Protocol Identification Number
NCT06036030
Brief Title
Combination Momordica Charantia Extract and Primaquine Againts Plasmodium Falciparum Uncomplicated and Plasmodium Vivax Uncomplicated Treatment in Manokwari, West Papua
Acronym
MCMPFPB
Official Title
Combination Momordica Charantia Extract and Primaquine Againts Plasmodium Falciparum Uncomplicated and Plasmodium Vivax Uncomplicated Treatment in Manokwari, West Papua
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 11, 2019 (Actual)
Primary Completion Date
April 16, 2019 (Actual)
Study Completion Date
April 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Syamsudin Abdillah,Ph.D, Pharm D
Collaborators
Cipto Mangunkusumo Hospital, PT Natura Nuswantara Nirmala

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria,Falciparum, Malaria, Vivax, Malaria, Infections, Uncomplicated Malaria, Uncomplicated Plasmodium Falciparum
Keywords
Momordica charantia, primaquine, combination therapy dihydroartemisinin, Plasmodium falciparum, Plasmodium vivax

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
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
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bitter melon fruit extract (Momordica charantia) with primaquine
Arm Type
Experimental
Arm Description
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.
Arm Title
dihydroartemisinin+piperaquine+ primaquine
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Dihydroartemisinin
Intervention Description
dihidroartemisinin dose of 2-4 mg/Kg Body weight taken for 3 days
Intervention Type
Drug
Intervention Name(s)
Piperaquine
Intervention Description
piperaquine at a dose of 16-32 mg/Kg body weight taken for 3 days
Intervention Type
Drug
Intervention Name(s)
Primaquine
Intervention Description
Primaquine dose 0.25 mg/kg body weight given to uncomplicated Plasmodium falciparum patients on the first day only
Intervention Type
Other
Intervention Name(s)
Momordica Charantia Extract
Intervention Description
Momordica charantia extract capsules at a dose of 325 mg were given to patients for 3 days
Primary Outcome Measure Information:
Title
development of sexual and asexual stages of Plasmodium falciparum
Description
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
Time Frame
0, 14, 28, and 42 days post-treatment
Secondary Outcome Measure Information:
Title
Parasite clearence times
Description
parasite reduction ratio
Time Frame
0, 14, 28, and 42 days post-treatment
Title
Fever clearance time
Description
time taken for the axilla temperature to fall below 37.5°C in patients who were febrile at inclusion
Time Frame
0, 14, 28, and 42 days post-treatment
Other Pre-specified Outcome Measures:
Title
Hemoglobin measurement
Description
Hematological study, measure in g/dl
Time Frame
0, 14, 28, and 42 days post-treatment
Title
Erytrocytes measurement
Description
Hematological study, measure in 10^6/mm³
Time Frame
0, 14, 28, and 42 days post-treatment
Title
Hematocrits measurement
Description
Hematological study, measure in %
Time Frame
0, 14, 28, and 42 days post-treatment
Title
Thrombocytes measurement
Description
Hematological study, measure in 10^3/mm³
Time Frame
0, 14, 28, and 42 days post-treatment
Title
Leucocytes measurement
Description
Hematological study, measure count in 1 µL
Time Frame
0, 14, 28, and 42 days post-treatment
Title
Albumin measurement
Description
Hematological study, measure in mg%
Time Frame
0, 14, 28, and 42 days post-treatment
Title
AST/SGOT measurement
Description
Blood chemistry, measure in µ/mL
Time Frame
0, 14, 28, and 42 days post-treatment
Title
total bilirubin measurement
Description
Blood chemistry, measure in mg %
Time Frame
0, 14, 28, and 42 days post-treatment
Title
Direct bilirubin measurement
Description
Blood chemistry, measure in mg %
Time Frame
0, 14, 28, and 42 days post-treatment
Title
Total protein measurement
Description
Blood chemistry, measure in mg %
Time Frame
0, 14, 28, and 42 days post-treatment
Title
Creatinine measurement
Description
Blood chemistry, measure in mg %
Time Frame
0, 14, 28, and 42 days post-treatment
Title
Ureum measurement
Description
Blood chemistry, measure in mg %
Time Frame
0, 14, 28, and 42 days post-treatment
Title
Gout measurement
Description
Blood chemistry, measure in mg %
Time Frame
0, 14, 28, and 42 days post-treatment
Title
Total Cholesterol measurement
Description
Lipid parameter, measure in mg/dL
Time Frame
0, 14, 28, and 42 days post-treatment
Title
Triglycerides measurement
Description
Lipid parameter, measure in mg/dL
Time Frame
0, 14, 28, and 42 days post-treatment
Title
Glucose measurement
Description
Glucose parameter, measure in mg/dL
Time Frame
0, 14, 28, and 42 days post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Manokwari Regional General Hospital
City
Manokwari
State/Province
West Papua
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
1 year
IPD Sharing Access Criteria
Sharing Access are only for research purposes.
Citations:
PubMed Identifier
25312101
Citation
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.
Results Reference
background
PubMed Identifier
29182587
Citation
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.
Results Reference
background
PubMed Identifier
31344411
Citation
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.
Results Reference
background
PubMed Identifier
36350105
Citation
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.
Results Reference
background
PubMed Identifier
26654101
Citation
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.
Results Reference
result

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

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