Combination Momordica Charantia Extract and Primaquine Againts Plasmodium Falciparum Uncomplicated and Plasmodium Vivax Uncomplicated Treatment in Manokwari, West Papua
Condition: Malaria,Falciparum; Malaria, Vivax; Malaria; Infections; Uncomplicated Malaria; Uncomplicated Plasmodium Falciparum
MeSH terms: Malaria; Malaria, Falciparum; Malaria, Vivax
Study type: Interventional
Phase: Phase 2

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)
    

Intervention name(s): Dihydroartemisinin; Piperaquine; Primaquine; Momordica Charantia Extract
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): dihidroartemisinin dose of 2-4 mg/Kg Body weight taken for 3 days; piperaquine at a dose of 16-32 mg/Kg body weight taken for 3 days; 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
Intervention MeSH terms: Primaquine; Piperaquine; Artenimol
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Momordica charantia; primaquine; combination therapy dihydroartemisinin; Plasmodium falciparum; Plasmodium vivax