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

Syamsudin Abdillah,Ph.D, Pharm D36 enrolled

Overview

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

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:

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Uncomplicated Plasmodium Falciparum

Interventions

DihydroartemisininDRUG

dihidroartemisinin dose of 2-4 mg/Kg Body weight taken for 3 days

PiperaquineDRUG

piperaquine at a dose of 16-32 mg/Kg body weight taken for 3 days

PrimaquineDRUG

Primaquine dose 0.25 mg/kg body weight given to uncomplicated Plasmodium falciparum patients on the first day only

Momordica Charantia ExtractDRUG

Momordica charantia extract capsules at a dose of 325 mg were given to patients for 3 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 28 day post treatment

Secondary Outcomes

Parasite clearence times

parasite reduction ratio

Time frame: 28-days

Fever clearence time

time taken for the axilla temperature to fall below 37.5°C in patients who were febrile at inclusion

Time frame: 28 days

Number of adverse event