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Uncomplicated Plasmodium FalciparumPhase 2MCHUPFNCT05829187

Momordica Charantia and Dihydroartemisinin-piperaquined-primaquine for Uncomplicated Plasmodium Falciparum Malaria Patients in Southwest Sumba Regency

A Phase 2 study testing Dihydroartemisinin, Piperaquine and Primaquine in people with Uncomplicated Plasmodium Falciparum, run by Syamsudin Abdillah,Ph.D, Pharm D at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Uncomplicated Plasmodium Falciparum
What is being tested?
Dihydroartemisinin, Piperaquine and Primaquine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteIndonesia
Study dates
1 Nov 2022to 31 Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Kori Puskesmas

    Tambolaka, East Nusa Tenggara, 87255

Other trials in Indonesia

About this study

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

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

Read the 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:

Being tested
Dihydroartemisinin, Piperaquine, Primaquine, Momordica Charantia Extract
Keywords
Parasite number, clinical symtomps, immunomodulator

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DihydroartemisininDrug

    Also called 1st group

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

  • PiperaquineDrug

    Also called 1st group

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

  • PrimaquineDrug

    Also called 1st Group

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

  • Momordica Charantia ExtractDrug

    Also called 2nd group

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

Study groups in NCT05829187
Study groupRoleWhat they receive
Dihydro artemisinin Piperakuin (Fixed Dose Combination) and PrimaquineExperimentalFixed 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.
Receives: Drug: Dihydroartemisinin; Drug: Piperaquine; Drug: Primaquine
Extract Capsul Momordica CharantiaExperimentalMomordica 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.
Receives: Drug: Momordica Charantia Extract

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 28 day post treatment

Secondary outcomes (3)

  1. Parasite clearence times

    parasite reduction ratio

    Measured: 28-days

  2. Fever clearence time

    time taken for the axilla temperature to fall below 37.5°C in patients who were febrile at inclusion

    Measured: 28 days

  3. Number of adverse event

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2023
  2. Study start1 Nov 2022
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Participant
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05829187
Sponsor's protocol ID
B-056/FI2/KEPK/TL.00/10/2022
Acronym
MCHUPF
Status last verified
May 2023
First submitted
9 Jan 2023
Last updated
16 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 25312101

  • 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.

    PubMed 23175563

  • 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.

    PubMed 29182587

  • 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.

    PubMed 31344411

  • 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.

    PubMed 36350105

  • 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.

    PubMed 26654101

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dihydroartemisinin, Piperaquine and Primaquine in people with Uncomplicated Plasmodium Falciparum, run by Syamsudin Abdillah,Ph.D, Pharm D at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

development of sexual and asexual stages of Plasmodium falciparum (time frame: 28 day post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05829187, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.

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