Clinical trial NCT05829187: Momordica Charantia and Dihydroartemisinin-piperaquined-primaquine for Uncomplicated Plasmodium Falciparum Malaria Patients in Southwest Sumba Regency
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uncomplicated Plasmodium Falciparum
Keywords: Parasite number, clinical symtomps, immunomodulator
Lead sponsor: Pancasila University
Sponsor class: OTHER
Collaborators: name: Apt. Dian Yudianto; Dr. dr Erni J. Nelwan, Sp.PD, Ph.D; Apt.Hesty Utami Ramadaniati, M.Clin, Pharm, Ph.D
First posted: 2023-04-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: 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: 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

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:

Eligibility criteria: Inclusion Criteria:-

1. Age ≥ 18 years old male or female up to 60 years old
2. Single Plasmodium falciparum infection based on microscopic examination.
3. Count the parasites for Plasmodium falciparum at least 2 large visual field asexual parasites (LPB) by examining 15 LPB
4. Density of parasites 1000-100,000/micro liter
5. Has no history of uncontrolled comorbidities
6. History of fever in the last 24 hours for falciparum malaria
7. Not taking other antimalarial drugs in the last 2 weeks.
8. Have no previous history of malaria.
9. Willing to come to the health facility according to the specified follow-up schedule.
10. Willing to participate in research and established procedures.
11. There is no history of allergy to antimalarial drugs.

Exclusion Criteria:

1. 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.
2. If the examination results show mixed Plasmodium and non-Plasmodium falciparum.
3. Has a history of severe liver, kidney and heart dysfunction, bradycardia and heart rhythm disturbances.
4. Does not control regularly according to the research schedule
5. Pregnant and lactating women
6. There are signs of severe malaria
7. Patients with chronic diseases, for example: heart, kidney, liver, HIV.
8. Mixed infection.

Primary outcomes:
measure: development of sexual and asexual stages of Plasmodium falciparum
timeFrame: 28 day post treatment
Secondary outcomes:
measure: Parasite clearence times
timeFrame: 28-days
measure: Fever clearence time
timeFrame: 28 days
measure: Number of adverse event
timeFrame: 28 days
Other outcomes:
measure: Measure imunomodulator Effect
timeFrame: 1x24 hour before and after treatment
Locations:
city: Tambolaka
country: Indonesia
facility: Kori Puskesmas
state: East Nusa Tenggara
Study officials:
References:
citation: 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.
citation: 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.
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.