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

Study Overview
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Brief Summary
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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
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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:

Official Title
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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

Conditions
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Uncomplicated Plasmodium Falciparum

Intervention / Treatment
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* Drug: Dihydroartemisinin
* Drug: Piperaquine
* Drug: Primaquine
* Drug: Momordica Charantia Extract


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dihydro artemisinin Piperakuin (Fixed Dose Combination) and Primaquine<br>Fixed Dose Combination content in the form of 40 mg dihydroartemisinin and 320 mg piperaquine administered for 3 days with a dose of dihydroartemisinin 2-4 mg/Kg body weight, piperaquine at a dose of 16-32 mg/Kg body weight in the form of a combination set out in the table based on body weight and age. Primaquine dose of 0.25 mg/Kg body weight is given only on the first day. Dihydroartemisinin-piperaquine was local product by PT Mersi Pharmaceuticals, batch No 220610, produced on Jun/22 and expiring on Jun/24. primaquine was local product by PT Phapros Indonesia, Batch No 56386001, produced on Jan/22 and expiring date jan/25. | Drug: Dihydroartemisinin<br>* dihidroartemisinin dose of 2-4 mg/Kg Body weight taken for 3 days<br>* Other names: 1st group;Drug: Piperaquine<br>* piperaquine at a dose of 16-32 mg/Kg body weight taken for 3 days<br>* Other names: 1st group;Drug: Primaquine<br>* Primaquine dose 0.25 mg/kg body weight given to uncomplicated Plasmodium falciparum patients on the first day only<br>* Other names: 1st Group;|
| Experimental: Extract Capsul Momordica Charantia<br>Momordica Charantia 325 mg in 500 mg capsules is given to patients with uncomplicated plasmodium falsiparum malaria as one capsule per day for three days for body weight less than 60 kg. Patients with a body weight of more than 60 kg are given two capsules per day for three days. | Drug: Momordica Charantia Extract<br>* Momordica charantia extract capsules at a dose of 325 mg were given to patients for 3 days<br>* Other names: 2nd group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 28 day post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parasite clearence times | parasite reduction ratio | 28-days | 
| Fever clearence time | time taken for the axilla temperature to fall below 37.5°C in patients who were febrile at inclusion | 28 days | 
| Number of adverse event |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parasite number, clinical symtomps, immunomodulator