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

NCT05829187 | Completed Phase 2 DMC

• 1 other identifier: B-056/FI2/KEPK/TL.00/10/2022
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Uncomplicated Plasmodium Falciparum

Keywords

Parasite number, clinical symtomps, immunomodulator

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

  28 day post treatment

Secondary Outcomes (3)

• Parasite clearence times

  28-days

• Fever clearence time

  28 days

• Number of adverse event

  28 days

Other Outcomes (1)

• Measure imunomodulator Effect

  1x24 hour before and after treatment

Study Arms (2)

Dihydro artemisinin Piperakuin (Fixed Dose Combination) and Primaquine

EXPERIMENTAL

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.

Drug: Dihydroartemisinin; Drug: Piperaquine; Drug: Primaquine

Extract Capsul Momordica Charantia

EXPERIMENTAL

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.

Drug: Momordica Charantia Extract

Interventions

Dihydroartemisinin DRUG

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

Also known as: 1st group

Dihydro artemisinin Piperakuin (Fixed Dose Combination) and Primaquine

Piperaquine DRUG

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

Also known as: 1st group

Dihydro artemisinin Piperakuin (Fixed Dose Combination) and Primaquine

Primaquine DRUG

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

Also known as: 1st Group

Dihydro artemisinin Piperakuin (Fixed Dose Combination) and Primaquine

Momordica Charantia Extract DRUG

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

Also known as: 2nd group

Extract Capsul Momordica Charantia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Syamsudin Abdillah,Ph.D, Pharm D: lead
• Apt. Dian Yudianto; Dr. dr Erni J. Nelwan, Sp.PD, Ph.D; Apt.Hesty Utami Ramadaniati, M.Clin, Pharm, Ph.D: collaborator

Study Sites (1)

Kori Puskesmas

Tambolaka, East Nusa Tenggara, 87255, Indonesia

Location

Related Publications (6)

• 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: 25312101 BACKGROUND

• 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.

  PMID: 23175563 BACKGROUND

• 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: 29182587 BACKGROUND

• 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: 31344411 BACKGROUND

• 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: 36350105 BACKGROUND

• 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: 26654101 RESULT

MeSH Terms

Interventions

artenimol; piperaquine; Primaquine; bitter melon extract

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• 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
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Apt. Syamsudin, M.Biomed, Ph.D

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.

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: April 25, 2023
• Study Start: November 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

ID (1)