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Completed

NCT Number: NCT05829187

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kori Puskesmas

Tambolaka, East Nusa Tenggara, 87255, Indonesia

About this study

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:

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dihydroartemisinin

Drug

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

Other names: 1st group

Piperaquine

Drug

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

Other names: 1st group

Primaquine

Drug

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

Other names: 1st Group

Momordica Charantia Extract

Drug

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

Other names: 2nd group

Primary outcomes

  1. development of sexual and asexual stages of Plasmodium falciparum

    Time frame: 28 day post treatment

    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 outcomes

  1. Parasite clearence times

    Time frame: 28-days

    parasite reduction ratio

  2. Fever clearence time

    Time frame: 28 days

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

  3. Number of adverse event

    Time frame: 28 days

Other outcomes

  1. Measure imunomodulator Effect

    Time frame: 1x24 hour before and after treatment

    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

Sponsors and collaborators

Lead sponsor

Syamsudin Abdillah,Ph.D, Pharm D

Other

Collaborators

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

Registry information

Official study 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

Acronym: MCHUPF

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 25, 2023
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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