Clinical trial NCT06036030: Combination Momordica Charantia Extract and Primaquine Againts Plasmodium Falciparum Uncomplicated and Plasmodium Vivax Uncomplicated Treatment in Manokwari, West Papua
Official title: Combination Momordica Charantia Extract and Primaquine Againts Plasmodium Falciparum Uncomplicated and Plasmodium Vivax Uncomplicated Treatment in Manokwari, West Papua
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malaria,Falciparum
Malaria, Vivax
Malaria
Infections
Uncomplicated Malaria
Uncomplicated Plasmodium Falciparum
Keywords: Momordica charantia
primaquine
combination therapy dihydroartemisinin
Plasmodium falciparum
Plasmodium vivax
Lead sponsor: Pancasila University
Sponsor class: OTHER
Collaborators: name: Cipto Mangunkusumo Hospital
name: PT Natura Nuswantara Nirmala
First posted: 2023-09-13
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: development of sexual and asexual stages of Plasmodium falciparum
timeFrame: 0, 14, 28, and 42 days post-treatment
Secondary outcomes:
measure: Parasite clearence times
timeFrame: 0, 14, 28, and 42 days post-treatment
measure: Fever clearance time
timeFrame: 0, 14, 28, and 42 days post-treatment
Other outcomes:
measure: Hemoglobin measurement
timeFrame: 0, 14, 28, and 42 days post-treatment
measure: Erytrocytes measurement
timeFrame: 0, 14, 28, and 42 days post-treatment
measure: Hematocrits measurement
timeFrame: 0, 14, 28, and 42 days post-treatment
measure: Thrombocytes measurement
timeFrame: 0, 14, 28, and 42 days post-treatment
measure: Leucocytes measurement
timeFrame: 0, 14, 28, and 42 days post-treatment
measure: Albumin measurement
timeFrame: 0, 14, 28, and 42 days post-treatment
measure: AST/SGOT measurement
timeFrame: 0, 14, 28, and 42 days post-treatment
measure: total bilirubin measurement
timeFrame: 0, 14, 28, and 42 days post-treatment
measure: Direct bilirubin measurement
timeFrame: 0, 14, 28, and 42 days post-treatment
measure: Total protein measurement
timeFrame: 0, 14, 28, and 42 days post-treatment
measure: Creatinine measurement
timeFrame: 0, 14, 28, and 42 days post-treatment
measure: Ureum measurement
timeFrame: 0, 14, 28, and 42 days post-treatment
measure: Gout measurement
timeFrame: 0, 14, 28, and 42 days post-treatment
measure: Total Cholesterol measurement
timeFrame: 0, 14, 28, and 42 days post-treatment
measure: Triglycerides measurement
timeFrame: 0, 14, 28, and 42 days post-treatment
measure: Glucose measurement
timeFrame: 0, 14, 28, and 42 days post-treatment
Locations:
city: Manokwari
country: Indonesia
facility: Manokwari Regional General Hospital
state: West Papua
Study officials:
References:
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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.
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.
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.
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.