Uncomplicated Plasmodium Falciparum
Conditions
Keywords
Parasite number, clinical symtomps, immunomodulator
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:
Interventions
dihidroartemisinin dose of 2-4 mg/Kg Body weight taken for 3 days
DRUGPiperaquine
piperaquine at a dose of 16-32 mg/Kg body weight taken for 3 days
DRUGPrimaquine
Primaquine dose 0.25 mg/kg body weight given to uncomplicated Plasmodium falciparum patients on the first day only
Momordica charantia extract capsules at a dose of 325 mg were given to patients for 3 days
Sponsors
Apt. Dian Yudianto; Dr. dr Erni J. Nelwan, Sp.PD, Ph.D; Apt.Hesty Utami Ramadaniati, M.Clin, Pharm, Ph.D
Syamsudin Abdillah,Ph.D, Pharm D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The test drug and the control drug are put into the capsule with the same weight, type and smell so that the patient cannot distinguish between the test drug and the control drug
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| development of sexual and asexual stages of Plasmodium falciparum | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parasite clearence times | 28-days | parasite reduction ratio |
| Fever clearence time | 28 days | time taken for the axilla temperature to fall below 37.5°C in patients who were febrile at inclusion |
| Number of adverse event | 28 days | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Measure imunomodulator Effect | 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 |
Countries
Indonesia
Outcome results
None listed