Back to resultsMomordica Charantia and Dihydroartemisinin-piperaquined-primaquine for Uncomplicated Plasmodium Falciparum Malaria Patients in Southwest Sumba Regency (MCHUPF)
Primary Purpose
Uncomplicated Plasmodium Falciparum
Status
Completed
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
Dihydroartemisinin
Piperaquine
Primaquine
Momordica Charantia Extract
Sponsored by
About this trial
This is an interventional treatment trial for Uncomplicated Plasmodium Falciparum focused on measuring Parasite number, clinical symtomps, immunomodulator
Eligibility Criteria
Inclusion Criteria:- Age ≥ 18 years old male or female up to 60 years old Single Plasmodium falciparum infection based on microscopic examination. Count the parasites for Plasmodium falciparum at least 2 large visual field asexual parasites (LPB) by examining 15 LPB Density of parasites 1000-100,000/micro liter Has no history of uncontrolled comorbidities History of fever in the last 24 hours for falciparum malaria Not taking other antimalarial drugs in the last 2 weeks. Have no previous history of malaria. Willing to come to the health facility according to the specified follow-up schedule. Willing to participate in research and established procedures. There is no history of allergy to antimalarial drugs. Exclusion Criteria: Signs of general weakness, or decreased consciousness or recurrent seizures or circulation failure or pulmonary edema or signs of anemia or yellow body and slightly red urine. If the examination results show mixed Plasmodium and non-Plasmodium falciparum. Has a history of severe liver, kidney and heart dysfunction, bradycardia and heart rhythm disturbances. Does not control regularly according to the research schedule Pregnant and lactating women There are signs of severe malaria Patients with chronic diseases, for example: heart, kidney, liver, HIV. Mixed infection.
Sites / Locations
- Kori Puskesmas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dihydro artemisinin Piperakuin (Fixed Dose Combination) and Primaquine
Extract Capsul Momordica Charantia
Arm Description
Fixed Dose Combination content in the form of 40 mg dihydroartemisinin and 320 mg piperaquine administered for 3 days with a dose of dihydroartemisinin 2-4 mg/Kg body weight, piperaquine at a dose of 16-32 mg/Kg body weight in the form of a combination set out in the table based on body weight and age. Primaquine dose of 0.25 mg/Kg body weight is given only on the first day. Dihydroartemisinin-piperaquine was local product by PT Mersi Pharmaceuticals, batch No 220610, produced on Jun/22 and expiring on Jun/24. primaquine was local product by PT Phapros Indonesia, Batch No 56386001, produced on Jan/22 and expiring date jan/25.
Momordica Charantia 325 mg in 500 mg capsules is given to patients with uncomplicated plasmodium falsiparum malaria as one capsule per day for three days for body weight less than 60 kg. Patients with a body weight of more than 60 kg are given two capsules per day for three days.
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 clearence time
time taken for the axilla temperature to fall below 37.5°C in patients who were febrile at inclusion
Number of adverse event
Full Information
NCT ID
NCT05829187
First Posted
January 9, 2023
Last Updated
May 13, 2023
Sponsor
Syamsudin Abdillah,Ph.D, Pharm D
Collaborators
Apt. Dian Yudianto; Dr. dr Erni J. Nelwan, Sp.PD, Ph.D; Apt.Hesty Utami Ramadaniati, M.Clin, Pharm, Ph.D
1. Study Identification
Unique Protocol Identification Number
NCT05829187
Brief Title
Momordica Charantia and Dihydroartemisinin-piperaquined-primaquine for Uncomplicated Plasmodium Falciparum Malaria Patients in Southwest Sumba Regency
Acronym
MCHUPF
Official Title
Effectiveness of Momordica Charantia Extract Compared to the Standard Antimalarial Drug Combination Dihydroartemisinin Piperaquine-primaquine in Patients With Uncomplicated Falciparum Malaria, in Sumba Barat Daya District of Indonesia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Syamsudin Abdillah,Ph.D, Pharm D
Collaborators
Apt. Dian Yudianto; Dr. dr Erni J. Nelwan, Sp.PD, Ph.D; Apt.Hesty Utami Ramadaniati, M.Clin, Pharm, Ph.D
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Currently, the first-line combination of artemisinin, piperaquine and prima-quine is quite effective in controlling malaria, however, the threat of spread of drug-resistant parasites has been reported. A study is conducted to assess the efficacy and safety extract of bitter melon (Momordica charantia/MC) regimens compared to the combination of dihydroartemisinin piperaquine primaquine (DHP+PQ) on the sexual and asexual stage of P. Falciparum uncomplicated in Sumba Barat Daya District, Indonesia
Detailed Description
The Study was conducted in Kori Primary Health Cender, Sumba Barat Daya District, East Nusa Tenggara Province on Sumba Island.
The study subject received either 3 day of dihydroartemisinin-piperaquine and primaquine 1 day on first day (DHP+PQ) or extract of bitter melon (Momordica charantia/MC) + Placebo 1 day on first day according to their body weight.
Patients with fever or history of fever within the past 24 hours were screened by microscopic examination of giemsa stained tihick blood films to detect Plasmodium falciparum infection.
All Patient were allocated by single blind randomization to receive DHP (on day 0 to day 2)+PQ (on day 0 only) or extract of bitter melon (Momordica charantia/MC) (on day 0 to day 2)+placebo (on day 0 only). The procedures of drug administration in the study were as follows:
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncomplicated Plasmodium Falciparum
Keywords
Parasite number, clinical symtomps, immunomodulator
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
Participant
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
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dihydro artemisinin Piperakuin (Fixed Dose Combination) and Primaquine
Arm Type
Experimental
Arm Description
Fixed Dose Combination content in the form of 40 mg dihydroartemisinin and 320 mg piperaquine administered for 3 days with a dose of dihydroartemisinin 2-4 mg/Kg body weight, piperaquine at a dose of 16-32 mg/Kg body weight in the form of a combination set out in the table based on body weight and age. Primaquine dose of 0.25 mg/Kg body weight is given only on the first day. Dihydroartemisinin-piperaquine was local product by PT Mersi Pharmaceuticals, batch No 220610, produced on Jun/22 and expiring on Jun/24. primaquine was local product by PT Phapros Indonesia, Batch No 56386001, produced on Jan/22 and expiring date jan/25.
Arm Title
Extract Capsul Momordica Charantia
Arm Type
Experimental
Arm Description
Momordica Charantia 325 mg in 500 mg capsules is given to patients with uncomplicated plasmodium falsiparum malaria as one capsule per day for three days for body weight less than 60 kg. Patients with a body weight of more than 60 kg are given two capsules per day for three days.
Intervention Type
Drug
Intervention Name(s)
Dihydroartemisinin
Other Intervention Name(s)
1st group
Intervention Description
dihidroartemisinin dose of 2-4 mg/Kg Body weight taken for 3 days
Intervention Type
Drug
Intervention Name(s)
Piperaquine
Other Intervention Name(s)
1st group
Intervention Description
piperaquine at a dose of 16-32 mg/Kg body weight taken for 3 days
Intervention Type
Drug
Intervention Name(s)
Primaquine
Other Intervention Name(s)
1st Group
Intervention Description
Primaquine dose 0.25 mg/kg body weight given to uncomplicated Plasmodium falciparum patients on the first day only
Intervention Type
Drug
Intervention Name(s)
Momordica Charantia Extract
Other Intervention Name(s)
2nd group
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
28 day post treatment
Secondary Outcome Measure Information:
Title
Parasite clearence times
Description
parasite reduction ratio
Time Frame
28-days
Title
Fever clearence time
Description
time taken for the axilla temperature to fall below 37.5°C in patients who were febrile at inclusion
Time Frame
28 days
Title
Number of adverse event
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
Measure imunomodulator Effect
Description
Measuring the immunomodulatory effect by measuring the levels of TNF alpha and interferon gamma cytokines before and after the treatment intervention 1 x 24 hours
Time Frame
1x24 hour before and after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:-
Age ≥ 18 years old male or female up to 60 years old
Single Plasmodium falciparum infection based on microscopic examination.
Count the parasites for Plasmodium falciparum at least 2 large visual field asexual parasites (LPB) by examining 15 LPB
Density of parasites 1000-100,000/micro liter
Has no history of uncontrolled comorbidities
History of fever in the last 24 hours for falciparum malaria
Not taking other antimalarial drugs in the last 2 weeks.
Have no previous history of malaria.
Willing to come to the health facility according to the specified follow-up schedule.
Willing to participate in research and established procedures.
There is no history of allergy to antimalarial drugs.
Exclusion Criteria:
Signs of general weakness, or decreased consciousness or recurrent seizures or circulation failure or pulmonary edema or signs of anemia or yellow body and slightly red urine.
If the examination results show mixed Plasmodium and non-Plasmodium falciparum.
Has a history of severe liver, kidney and heart dysfunction, bradycardia and heart rhythm disturbances.
Does not control regularly according to the research schedule
Pregnant and lactating women
There are signs of severe malaria
Patients with chronic diseases, for example: heart, kidney, liver, HIV.
Mixed infection.
Facility Information:
Facility Name
Kori Puskesmas
City
Tambolaka
State/Province
East Nusa Tenggara
ZIP/Postal Code
87255
Country
Indonesia
12. IPD Sharing Statement
Citations:
PubMed Identifier
25312101
Citation
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Results Reference
background
PubMed Identifier
23175563
Citation
Sutanto I, Suprijanto S, Kosasih A, Dahlan MS, Syafruddin D, Kusriastuti R, Hawley WA, Lobo NF, Ter Kuile FO. The effect of primaquine on gametocyte development and clearance in the treatment of uncomplicated falciparum malaria with dihydroartemisinin-piperaquine in South sumatra, Western indonesia: an open-label, randomized, controlled trial. Clin Infect Dis. 2013 Mar;56(5):685-93. doi: 10.1093/cid/cis959. Epub 2012 Nov 21.
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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Momordica Charantia and Dihydroartemisinin-piperaquined-primaquine for Uncomplicated Plasmodium Falciparum Malaria Patients in Southwest Sumba Regency
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