Malaria,Falciparum, Malaria, Vivax, Malaria, Infections, Uncomplicated Malaria, Uncomplicated Plasmodium Falciparum
Conditions
Keywords
Momordica charantia, primaquine, combination therapy dihydroartemisinin, Plasmodium falciparum, Plasmodium vivax
Brief summary
Comparing the efficacy of the combination treatment of bitter melon fruit extract (Momordica charantia) with primaquine (MC+PQ) against the combination of dihydroartemisinin + piperaquine + primaquine (DHP+PQ) on patients with Plasmodium falciparum and Plasmodium vivax without complications in Manokwari, West Papua, Indonesia. The research was conducted from January 2019 to April 2019 at Manokwari Regional General Hospital, West Papua. Open label, 2 parallel randomized clinical studies with Plasmodium falciparum malaria patients without complications (Study 1) and patients with Plasmodium vivax malaria without complications (Study 2). The randomized clinical trial divided in 2 treatment groups, namely the MC+PQ and DHP+PQ. The Success of the treatment was determined by the combination of blood schizontocidal therapy in radical cure. The overall final assessed results were the average value of parasitological failure, hematological measurements, liver function, kidney function, blood lipid levels, blood glucose levels and adverse events until day 42.
Detailed description
Every group therapy session was under team member supervision, required to complete follow-up visits on days 1, 2, 3, 5, 7, 14, 21, 28, 35, and 42. All of the studies 1 and 2 was split into more than two treatment groups, MC+PQ and DHP+PQ. The study was broken up into several 2 studies. Plasmodium falciparum patients without complications (n = 50 in each study) were the subjects of study 1, and Plasmodium vivax patients without complications (n = 50) were the subjects of studies 2 and 3. The combination of 500 mg of bitter melon fruit extract (Momordica charantia) and 325 mg of bitter melon fruit content (13.50 mg/kg body weight) was initially approved by the MC+PQ group and administered for 3 days. 15 mg Primaquine dose single (0.25 mg/kg body weight) was administered for patients with Plasmodium falciparum and Plasmodium vivax malaria. Patients with Plasmodium falciparum malaria was treated for the first 14 days, while those with Plasmodium vivax malaria were treated for 14 days. The 2nd DHP+PQ group received three days of DHP (fixed dose combination tablets of 40 mg dihydroartemisinin and 320 mg piperaquine; DHP-FRIMAL, Mersi pharmaceutical, Tbk) in addition to 15 mg primaquine that had previously been given for one day to patients with Plasmodium falciparum who had no complications and for 14 days to those with Plasmodium vivax. DHP renewal is determined by body weight (age 15 years, \>40-60 kg: 3 tablets; \>60-80 kg: 4 tablets; 80 kg: 5 tablets)
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
Dr Cipto Mangunkusumo General Hospital
PT Natura Nuswantara Nirmala
Syamsudin Abdillah,Ph.D, Pharm D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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
15 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* incomplete therapy patients * Age ≥15 years old male or female up to 60 years old. * diagnosis and an outcome inspection microscopically suffering from Plasmodium falciparum malaria or Plasmodium vivax with density parasites 1000-100,000/µL * History of fever within the past 24-48 hours with axillary temperature ≥ 37.5°C * There were no signs of severe malaria * had no chronic disease * willing to follow up for 42 days; No consuming other antimalarial drugs within 2 weeks; willingly to participate in investigations and follow established procedures (informed consent)
Exclusion criteria
* pregnant female, breastfeeding female, children and infants * suffering a mental disturbance, heavy illness like kidney, liver, tuberculosis, cancer, AIDS and other heavy diseases * one set of symptom or signs of severe malaria * had a history of hypersensitivity, allergies, and antimalarial contraindications * not willingly to follow the inquiry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| development of sexual and asexual stages of Plasmodium falciparum | 0, 14, 28, and 42 days 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 | 0, 14, 28, and 42 days post-treatment | parasite reduction ratio |
| Fever clearance time | 0, 14, 28, and 42 days post-treatment | time taken for the axilla temperature to fall below 37.5°C in patients who were febrile at inclusion |
Other
| Measure | Time frame | Description |
|---|---|---|
| Direct bilirubin measurement | 0, 14, 28, and 42 days post-treatment | Blood chemistry, measure in mg % |
| Thrombocytes measurement | 0, 14, 28, and 42 days post-treatment | Hematological study, measure in 10\^3/mm³ |
| Leucocytes measurement | 0, 14, 28, and 42 days post-treatment | Hematological study, measure count in 1 µL |
| Albumin measurement | 0, 14, 28, and 42 days post-treatment | Hematological study, measure in mg% |
| AST/SGOT measurement | 0, 14, 28, and 42 days post-treatment | Blood chemistry, measure in µ/mL |
| total bilirubin measurement | 0, 14, 28, and 42 days post-treatment | Blood chemistry, measure in mg % |
| Hemoglobin measurement | 0, 14, 28, and 42 days post-treatment | Hematological study, measure in g/dl |
| Creatinine measurement | 0, 14, 28, and 42 days post-treatment | Blood chemistry, measure in mg % |
| Ureum measurement | 0, 14, 28, and 42 days post-treatment | Blood chemistry, measure in mg % |
| Gout measurement | 0, 14, 28, and 42 days post-treatment | Blood chemistry, measure in mg % |
| Total Cholesterol measurement | 0, 14, 28, and 42 days post-treatment | Lipid parameter, measure in mg/dL |
| Triglycerides measurement | 0, 14, 28, and 42 days post-treatment | Lipid parameter, measure in mg/dL |
| Glucose measurement | 0, 14, 28, and 42 days post-treatment | Glucose parameter, measure in mg/dL |
| Total protein measurement | 0, 14, 28, and 42 days post-treatment | Blood chemistry, measure in mg % |
| Erytrocytes measurement | 0, 14, 28, and 42 days post-treatment | Hematological study, measure in 10\^6/mm³ |
| Hematocrits measurement | 0, 14, 28, and 42 days post-treatment | Hematological study, measure in % |
Countries
Indonesia
Outcome results
None listed