Combination Momordica Charantia Extract and Primaquine Againts Plasmodium Falciparum Uncomplicated and Plasmodium Vivax Uncomplicated Treatment in Manokwari, West Papua

Malaria Clinical Trial

— MCMPFPB  

Official title:

Combination Momordica Charantia Extract and Primaquine Againts Plasmodium Falciparum Uncomplicated and Plasmodium Vivax Uncomplicated Treatment in Manokwari, West Papua

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06036030
• Other study ID #: MCMPFPB2019
• Status: Completed
• Phase: Phase 2
• Start date: January 11, 2019
• Est. completion date: April 16, 2019

Study information

• Verified date: September 2023
• Source: Pancasila University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 16, 2019
• Est. primary completion date: April 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Malaria
• Malaria, Falciparum
• Malaria, Vivax
• Malaria,Falciparum
• Uncomplicated Malaria

Intervention

Drug:
• Dihydroartemisinin
dihidroartemisinin dose of 2-4 mg/Kg Body weight taken for 3 days
• Piperaquine
piperaquine at a dose of 16-32 mg/Kg body weight taken for 3 days
• Primaquine
Primaquine dose 0.25 mg/kg body weight given to uncomplicated Plasmodium falciparum patients on the first day only

Other:
• Momordica Charantia Extract
Momordica charantia extract capsules at a dose of 325 mg were given to patients for 3 days

Locations

Country	Name	City	State
Indonesia	Manokwari Regional General Hospital	Manokwari	West Papua

Sponsors (3)

Lead Sponsor	Collaborator
Syamsudin Abdillah,Ph.D, Pharm D	Cipto Mangunkusumo Hospital, PT Natura Nuswantara Nirmala

Country where clinical trial is conducted

Indonesia, 

References & Publications (5)

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. — View 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. — View 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. — View 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 art — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hemoglobin measurement	Hematological study, measure in g/dl	0, 14, 28, and 42 days post-treatment
Other	Erytrocytes measurement	Hematological study, measure in 10^6/mm³	0, 14, 28, and 42 days post-treatment
Other	Hematocrits measurement	Hematological study, measure in %	0, 14, 28, and 42 days post-treatment
Other	Thrombocytes measurement	Hematological study, measure in 10^3/mm³	0, 14, 28, and 42 days post-treatment
Other	Leucocytes measurement	Hematological study, measure count in 1 µL	0, 14, 28, and 42 days post-treatment
Other	Albumin measurement	Hematological study, measure in mg%	0, 14, 28, and 42 days post-treatment
Other	AST/SGOT measurement	Blood chemistry, measure in µ/mL	0, 14, 28, and 42 days post-treatment
Other	total bilirubin measurement	Blood chemistry, measure in mg %	0, 14, 28, and 42 days post-treatment
Other	Direct bilirubin measurement	Blood chemistry, measure in mg %	0, 14, 28, and 42 days post-treatment
Other	Total protein measurement	Blood chemistry, measure in mg %	0, 14, 28, and 42 days post-treatment
Other	Creatinine measurement	Blood chemistry, measure in mg %	0, 14, 28, and 42 days post-treatment
Other	Ureum measurement	Blood chemistry, measure in mg %	0, 14, 28, and 42 days post-treatment
Other	Gout measurement	Blood chemistry, measure in mg %	0, 14, 28, and 42 days post-treatment
Other	Total Cholesterol measurement	Lipid parameter, measure in mg/dL	0, 14, 28, and 42 days post-treatment
Other	Triglycerides measurement	Lipid parameter, measure in mg/dL	0, 14, 28, and 42 days post-treatment
Other	Glucose measurement	Glucose parameter, measure in mg/dL	0, 14, 28, and 42 days post-treatment
Primary	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	0, 14, 28, and 42 days post-treatment
Secondary	Parasite clearence times	parasite reduction ratio	0, 14, 28, and 42 days post-treatment
Secondary	Fever clearance time	time taken for the axilla temperature to fall below 37.5°C in patients who were febrile at inclusion	0, 14, 28, and 42 days post-treatment