Kori Puskesmas
Tambolaka, East Nusa Tenggara, 87255, Indonesia
NCT Number: NCT05829187
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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Notify Me18 year–60 year
All sexes
Interventional
Phase 2
Tambolaka, East Nusa Tenggara, 87255, Indonesia
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-
Exclusion criteria
dihidroartemisinin dose of 2-4 mg/Kg Body weight taken for 3 days
Other names: 1st group
piperaquine at a dose of 16-32 mg/Kg body weight taken for 3 days
Other names: 1st group
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 capsules at a dose of 325 mg were given to patients for 3 days
Other names: 2nd group
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
Time frame: 28-days
parasite reduction ratio
Time frame: 28 days
time taken for the axilla temperature to fall below 37.5°C in patients who were febrile at inclusion
Time frame: 28 days
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
Syamsudin Abdillah,Ph.D, Pharm D
Other
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
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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