xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06036030</url>
    </required_header>
    <id_info>
      <org_study_id>MCMPFPB2019</org_study_id>
      <nct_id>NCT06036030</nct_id>
    </id_info>
    <brief_title>Combination Momordica Charantia Extract and Primaquine Againts Plasmodium Falciparum Uncomplicated and Plasmodium Vivax Uncomplicated Treatment in Manokwari, West Papua</brief_title>
    <acronym>MCMPFPB</acronym>
    <official_title>Combination Momordica Charantia Extract and Primaquine Againts Plasmodium Falciparum Uncomplicated and Plasmodium Vivax Uncomplicated Treatment in Manokwari, West Papua</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Syamsudin Abdillah,Ph.D, Pharm D</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Cipto Mangunkusumo Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>PT Natura Nuswantara Nirmala</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Pancasila University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Comparing the efficacy of the combination treatment of bitter melon fruit extract (Momordica&#xD;
        charantia) with primaquine (MC+PQ) against the combination of dihydroartemisinin +&#xD;
        piperaquine + primaquine (DHP+PQ) on patients with Plasmodium falciparum and Plasmodium vivax&#xD;
        without complications in Manokwari, West Papua, Indonesia. The research was conducted from&#xD;
        January 2019 to April 2019 at Manokwari Regional General Hospital, West Papua. Open label, 2&#xD;
        parallel randomized clinical studies with Plasmodium falciparum malaria patients without&#xD;
        complications (Study 1) and patients with Plasmodium vivax malaria without complications&#xD;
        (Study 2). The randomized clinical trial divided in 2 treatment groups, namely the MC+PQ and&#xD;
        DHP+PQ. The Success of the treatment was determined by the combination of blood&#xD;
        schizontocidal therapy in radical cure. The overall final assessed results were the average&#xD;
        value of parasitological failure, hematological measurements, liver function, kidney&#xD;
        function, blood lipid levels, blood glucose levels and adverse events until day 42.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Every group therapy session was under team member supervision, required to complete follow-up&#xD;
        visits on days 1, 2, 3, 5, 7, 14, 21, 28, 35, and 42. All of the studies 1 and 2 was split&#xD;
        into more than two treatment groups, MC+PQ and DHP+PQ. The study was broken up into several 2&#xD;
        studies. Plasmodium falciparum patients without complications (n = 50 in each study) were the&#xD;
        subjects of study 1, and Plasmodium vivax patients without complications (n = 50) were the&#xD;
        subjects of studies 2 and 3.&#xD;
  &#xD;
        The combination of 500 mg of bitter melon fruit extract (Momordica charantia) and 325 mg of&#xD;
        bitter melon fruit content (13.50 mg/kg body weight) was initially approved by the MC+PQ&#xD;
        group and administered for 3 days. 15 mg Primaquine dose single (0.25 mg/kg body weight) was&#xD;
        administered for patients with Plasmodium falciparum and Plasmodium vivax malaria. Patients&#xD;
        with Plasmodium falciparum malaria was treated for the first 14 days, while those with&#xD;
        Plasmodium vivax malaria were treated for 14 days.&#xD;
  &#xD;
        The 2nd DHP+PQ group received three days of DHP (fixed dose combination tablets of 40 mg&#xD;
        dihydroartemisinin and 320 mg piperaquine; DHP-FRIMAL, Mersi pharmaceutical, Tbk) in addition&#xD;
        to 15 mg primaquine that had previously been given for one day to patients with Plasmodium&#xD;
        falciparum who had no complications and for 14 days to those with Plasmodium vivax. DHP&#xD;
        renewal is determined by body weight (age 15 years, &gt;40-60 kg: 3 tablets; &gt;60-80 kg: 4&#xD;
        tablets; 80 kg: 5 tablets)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 11, 2019</start_date>
    <completion_date type="Actual">April 16, 2019</completion_date>
    <primary_completion_date type="Actual">April 16, 2019</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <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.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <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</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>development of sexual and asexual stages of Plasmodium falciparum</measure>
      <time_frame>0, 14, 28, and 42 days post-treatment</time_frame>
      <description>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</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Parasite clearence times</measure>
      <time_frame>0, 14, 28, and 42 days post-treatment</time_frame>
      <description>parasite reduction ratio</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fever clearance time</measure>
      <time_frame>0, 14, 28, and 42 days post-treatment</time_frame>
      <description>time taken for the axilla temperature to fall below 37.5°C in patients who were febrile at inclusion</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Hemoglobin measurement</measure>
      <time_frame>0, 14, 28, and 42 days post-treatment</time_frame>
      <description>Hematological study, measure in g/dl</description>
    </other_outcome>
    <other_outcome>
      <measure>Erytrocytes measurement</measure>
      <time_frame>0, 14, 28, and 42 days post-treatment</time_frame>
      <description>Hematological study, measure in 10^6/mm³</description>
    </other_outcome>
    <other_outcome>
      <measure>Hematocrits measurement</measure>
      <time_frame>0, 14, 28, and 42 days post-treatment</time_frame>
      <description>Hematological study, measure in %</description>
    </other_outcome>
    <other_outcome>
      <measure>Thrombocytes measurement</measure>
      <time_frame>0, 14, 28, and 42 days post-treatment</time_frame>
      <description>Hematological study, measure in 10^3/mm³</description>
    </other_outcome>
    <other_outcome>
      <measure>Leucocytes measurement</measure>
      <time_frame>0, 14, 28, and 42 days post-treatment</time_frame>
      <description>Hematological study, measure count in 1 µL</description>
    </other_outcome>
    <other_outcome>
      <measure>Albumin measurement</measure>
      <time_frame>0, 14, 28, and 42 days post-treatment</time_frame>
      <description>Hematological study, measure in mg%</description>
    </other_outcome>
    <other_outcome>
      <measure>AST/SGOT measurement</measure>
      <time_frame>0, 14, 28, and 42 days post-treatment</time_frame>
      <description>Blood chemistry, measure in µ/mL</description>
    </other_outcome>
    <other_outcome>
      <measure>total bilirubin measurement</measure>
      <time_frame>0, 14, 28, and 42 days post-treatment</time_frame>
      <description>Blood chemistry, measure in mg %</description>
    </other_outcome>
    <other_outcome>
      <measure>Direct bilirubin measurement</measure>
      <time_frame>0, 14, 28, and 42 days post-treatment</time_frame>
      <description>Blood chemistry, measure in mg %</description>
    </other_outcome>
    <other_outcome>
      <measure>Total protein measurement</measure>
      <time_frame>0, 14, 28, and 42 days post-treatment</time_frame>
      <description>Blood chemistry, measure in mg %</description>
    </other_outcome>
    <other_outcome>
      <measure>Creatinine measurement</measure>
      <time_frame>0, 14, 28, and 42 days post-treatment</time_frame>
      <description>Blood chemistry, measure in mg %</description>
    </other_outcome>
    <other_outcome>
      <measure>Ureum measurement</measure>
      <time_frame>0, 14, 28, and 42 days post-treatment</time_frame>
      <description>Blood chemistry, measure in mg %</description>
    </other_outcome>
    <other_outcome>
      <measure>Gout measurement</measure>
      <time_frame>0, 14, 28, and 42 days post-treatment</time_frame>
      <description>Blood chemistry, measure in mg %</description>
    </other_outcome>
    <other_outcome>
      <measure>Total Cholesterol measurement</measure>
      <time_frame>0, 14, 28, and 42 days post-treatment</time_frame>
      <description>Lipid parameter, measure in mg/dL</description>
    </other_outcome>
    <other_outcome>
      <measure>Triglycerides measurement</measure>
      <time_frame>0, 14, 28, and 42 days post-treatment</time_frame>
      <description>Lipid parameter, measure in mg/dL</description>
    </other_outcome>
    <other_outcome>
      <measure>Glucose measurement</measure>
      <time_frame>0, 14, 28, and 42 days post-treatment</time_frame>
      <description>Glucose parameter, measure in mg/dL</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">50</enrollment>
    <condition>Malaria,Falciparum</condition>
    <condition>Malaria, Vivax</condition>
    <condition>Malaria</condition>
    <condition>Infections</condition>
    <condition>Uncomplicated Malaria</condition>
    <condition>Uncomplicated Plasmodium Falciparum</condition>
    <arm_group>
      <arm_group_label>bitter melon fruit extract (Momordica charantia) with primaquine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>For three days, a 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 administered. those with Plasmodium falciparum and Plasmodium vivax malaria received a single dosage of primaquine (0.25 mg/kg body weight) once daily, with those with Plasmodium falciparum malaria receiving it for 14 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>dihydroartemisinin+piperaquine+ primaquine</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>DHP (fixed dosage combination tablets containing 40 mg dihydroartemisinin and 320 mg piperaquine) was administered to the group for 3 days, with primaquine being administered for 14 days to patients with Plasmodium vivax and 1 day initially to those with Plasmodium falciparum without difficulties. Body weight is taken into consideration while setting therapy parameters (age 15 years, &gt;40-60 kg: 3 tablets; &gt;60-80 kg: 4 tablets; 80 kg: 5 tablets).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dihydroartemisinin</intervention_name>
      <description>dihidroartemisinin dose of 2-4 mg/Kg Body weight taken for 3 days</description>
      <arm_group_label>dihydroartemisinin+piperaquine+ primaquine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Piperaquine</intervention_name>
      <description>piperaquine at a dose of 16-32 mg/Kg body weight taken for 3 days</description>
      <arm_group_label>dihydroartemisinin+piperaquine+ primaquine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Primaquine</intervention_name>
      <description>Primaquine dose 0.25 mg/kg body weight given to uncomplicated Plasmodium falciparum patients on the first day only</description>
      <arm_group_label>bitter melon fruit extract (Momordica charantia) with primaquine</arm_group_label>
      <arm_group_label>dihydroartemisinin+piperaquine+ primaquine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Momordica Charantia Extract</intervention_name>
      <description>Momordica charantia extract capsules at a dose of 325 mg were given to patients for 3 days</description>
      <arm_group_label>bitter melon fruit extract (Momordica charantia) with primaquine</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  incomplete therapy patients&#xD;
  &#xD;
            -  Age ≥15 years old male or female up to 60 years old.&#xD;
  &#xD;
            -  diagnosis and an outcome inspection microscopically suffering from Plasmodium&#xD;
               falciparum malaria or Plasmodium vivax with density parasites 1000-100,000/µL&#xD;
  &#xD;
            -  History of fever within the past 24-48 hours with axillary temperature ≥ 37.5°C&#xD;
  &#xD;
            -  There were no signs of severe malaria&#xD;
  &#xD;
            -  had no chronic disease&#xD;
  &#xD;
            -  willing to follow up for 42 days; No consuming other antimalarial drugs within 2&#xD;
               weeks; willingly to participate in investigations and follow established procedures&#xD;
               (informed consent)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  pregnant female, breastfeeding female, children and infants&#xD;
  &#xD;
            -  suffering a mental disturbance, heavy illness like kidney, liver, tuberculosis,&#xD;
               cancer, AIDS and other heavy diseases&#xD;
  &#xD;
            -  one set of symptom or signs of severe malaria&#xD;
  &#xD;
            -  had a history of hypersensitivity, allergies, and antimalarial contraindications&#xD;
  &#xD;
            -  not willingly to follow the inquiry&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Manokwari Regional General Hospital</name>
        <address>
          <city>Manokwari</city>
          <state>West Papua</state>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <reference>
      <citation>Abdillah S, Tambunan RM, Sinaga YM, Farida Y. Ethno-botanical survey of plants used in the traditional treatment of malaria in Sei Kepayang, Asahan of North Sumatera. Asian Pac J Trop Med. 2014 Sep;7S1:S104-7. doi: 10.1016/S1995-7645(14)60213-3.</citation>
      <PMID>25312101</PMID>
    </reference>
    <reference>
      <citation>Jia S, Shen M, Zhang F, Xie J. Recent Advances in Momordica charantia: Functional Components and Biological Activities. Int J Mol Sci. 2017 Nov 28;18(12):2555. doi: 10.3390/ijms18122555.</citation>
      <PMID>29182587</PMID>
    </reference>
    <reference>
      <citation>Chen F, Huang G, Yang Z, Hou Y. Antioxidant activity of Momordica charantia polysaccharide and its derivatives. Int J Biol Macromol. 2019 Oct 1;138:673-680. doi: 10.1016/j.ijbiomac.2019.07.129. Epub 2019 Jul 22.</citation>
      <PMID>31344411</PMID>
    </reference>
    <reference>
      <citation>Wang S, Liu Q, Zeng T, Zhan J, Zhao H, Ho CT, Xiao Y, Li S. Immunomodulatory effects and associated mechanisms of Momordica charantia and its phytochemicals. Food Funct. 2022 Nov 28;13(23):11986-11998. doi: 10.1039/d2fo02096c.</citation>
      <PMID>36350105</PMID>
    </reference>
    <results_reference>
      <citation>Nelwan EJ, Ekawati LL, Tjahjono B, Setiabudy R, Sutanto I, Chand K, Ekasari T, Djoko D, Basri H, Taylor WR, Duparc S, Subekti D, Elyazar I, Noviyanti R, Sudoyo H, Baird JK. Randomized trial of primaquine hypnozoitocidal efficacy when administered with artemisinin-combined blood schizontocides for radical cure of Plasmodium vivax in Indonesia. BMC Med. 2015 Dec 11;13:294. doi: 10.1186/s12916-015-0535-9.</citation>
      <PMID>26654101</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Pancasila University</investigator_affiliation>
      <investigator_full_name>Syamsudin Abdillah,Ph.D, Pharm D</investigator_full_name>
      <investigator_title>Profesor Dr Syamsudin Abdillah, M.Biomed</investigator_title>
    </responsible_party>
    <keyword>Momordica charantia</keyword>
    <keyword>primaquine</keyword>
    <keyword>combination therapy dihydroartemisinin</keyword>
    <keyword>Plasmodium falciparum</keyword>
    <keyword>Plasmodium vivax</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Malaria</mesh_term>
      <mesh_term>Malaria, Falciparum</mesh_term>
      <mesh_term>Malaria, Vivax</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Piperaquine</mesh_term>
      <mesh_term>Primaquine</mesh_term>
      <mesh_term>Artenimol</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>1 year</ipd_time_frame>
      <ipd_access_criteria>Sharing Access are only for research purposes.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06036030
  org study id: MCMPFPB2019
  nct id: NCT06036030
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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)
  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.
  primary purpose: Treatment
  masking: None (Open Label)
  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
  measure: development of sexual and asexual stages of Plasmodium falciparum
  time frame: 0, 14, 28, and 42 days post-treatment
  description: 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
  measure: Parasite clearence times
  time frame: 0, 14, 28, and 42 days post-treatment
  description: parasite reduction ratio
  measure: Fever clearance time
  time frame: 0, 14, 28, and 42 days post-treatment
  description: time taken for the axilla temperature to fall below 37.5°C in patients who were febrile at inclusion
  measure: Hemoglobin measurement
  time frame: 0, 14, 28, and 42 days post-treatment
  description: Hematological study, measure in g/dl
  measure: Erytrocytes measurement
  time frame: 0, 14, 28, and 42 days post-treatment
  description: Hematological study, measure in 10^6/mm³
  measure: Hematocrits measurement
  time frame: 0, 14, 28, and 42 days post-treatment
  description: Hematological study, measure in %
  measure: Thrombocytes measurement
  time frame: 0, 14, 28, and 42 days post-treatment
  description: Hematological study, measure in 10^3/mm³
  measure: Leucocytes measurement
  time frame: 0, 14, 28, and 42 days post-treatment
  description: Hematological study, measure count in 1 µL
  measure: Albumin measurement
  time frame: 0, 14, 28, and 42 days post-treatment
  description: Hematological study, measure in mg%
  measure: AST/SGOT measurement
  time frame: 0, 14, 28, and 42 days post-treatment
  description: Blood chemistry, measure in µ/mL
  measure: total bilirubin measurement
  time frame: 0, 14, 28, and 42 days post-treatment
  description: Blood chemistry, measure in mg %
  measure: Direct bilirubin measurement
  time frame: 0, 14, 28, and 42 days post-treatment
  description: Blood chemistry, measure in mg %
  measure: Total protein measurement
  time frame: 0, 14, 28, and 42 days post-treatment
  description: Blood chemistry, measure in mg %
  measure: Creatinine measurement
  time frame: 0, 14, 28, and 42 days post-treatment
  description: Blood chemistry, measure in mg %
  measure: Ureum measurement
  time frame: 0, 14, 28, and 42 days post-treatment
  description: Blood chemistry, measure in mg %
  measure: Gout measurement
  time frame: 0, 14, 28, and 42 days post-treatment
  description: Blood chemistry, measure in mg %
  measure: Total Cholesterol measurement
  time frame: 0, 14, 28, and 42 days post-treatment
  description: Lipid parameter, measure in mg/dL
  measure: Triglycerides measurement
  time frame: 0, 14, 28, and 42 days post-treatment
  description: Lipid parameter, measure in mg/dL
  measure: Glucose measurement
  time frame: 0, 14, 28, and 42 days post-treatment
  description: Glucose parameter, measure in mg/dL
  arm group label: bitter melon fruit extract (Momordica charantia) with primaquine
  arm group type: Experimental
  description: For three days, a 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 administered. those with Plasmodium falciparum and Plasmodium vivax malaria received a single dosage of primaquine (0.25 mg/kg body weight) once daily, with those with Plasmodium falciparum malaria receiving it for 14 days.
  arm group label: dihydroartemisinin+piperaquine+ primaquine
  arm group type: Active Comparator
  description: DHP (fixed dosage combination tablets containing 40 mg dihydroartemisinin and 320 mg piperaquine) was administered to the group for 3 days, with primaquine being administered for 14 days to patients with Plasmodium vivax and 1 day initially to those with Plasmodium falciparum without difficulties. Body weight is taken into consideration while setting therapy parameters (age 15 years, >40-60 kg: 3 tablets; >60-80 kg: 4 tablets; 80 kg: 5 tablets).
  intervention type: Drug
  intervention name: Dihydroartemisinin
  description: dihidroartemisinin dose of 2-4 mg/Kg Body weight taken for 3 days
  arm group label: dihydroartemisinin+piperaquine+ primaquine
  intervention type: Drug
  intervention name: Piperaquine
  description: piperaquine at a dose of 16-32 mg/Kg body weight taken for 3 days
  arm group label: dihydroartemisinin+piperaquine+ primaquine
  intervention type: Drug
  intervention name: Primaquine
  description: Primaquine dose 0.25 mg/kg body weight given to uncomplicated Plasmodium falciparum patients on the first day only
  arm group label: bitter melon fruit extract (Momordica charantia) with primaquine
  arm group label: dihydroartemisinin+piperaquine+ primaquine
  intervention type: Other
  intervention name: Momordica Charantia Extract
  description: Momordica charantia extract capsules at a dose of 325 mg were given to patients for 3 days
  arm group label: bitter melon fruit extract (Momordica charantia) with primaquine
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 60 Years
  healthy volunteers: No
  facility: 
  country: Indonesia
  citation: Abdillah S, Tambunan RM, Sinaga YM, Farida Y. Ethno-botanical survey of plants used in the traditional treatment of malaria in Sei Kepayang, Asahan of North Sumatera. Asian Pac J Trop Med. 2014 Sep;7S1:S104-7. doi: 10.1016/S1995-7645(14)60213-3.
  PMID: 25312101
  citation: Jia S, Shen M, Zhang F, Xie J. Recent Advances in Momordica charantia: Functional Components and Biological Activities. Int J Mol Sci. 2017 Nov 28;18(12):2555. doi: 10.3390/ijms18122555.
  PMID: 29182587
  citation: Chen F, Huang G, Yang Z, Hou Y. Antioxidant activity of Momordica charantia polysaccharide and its derivatives. Int J Biol Macromol. 2019 Oct 1;138:673-680. doi: 10.1016/j.ijbiomac.2019.07.129. Epub 2019 Jul 22.
  PMID: 31344411
  citation: Wang S, Liu Q, Zeng T, Zhan J, Zhao H, Ho CT, Xiao Y, Li S. Immunomodulatory effects and associated mechanisms of Momordica charantia and its phytochemicals. Food Funct. 2022 Nov 28;13(23):11986-11998. doi: 10.1039/d2fo02096c.
  PMID: 36350105
  citation: Nelwan EJ, Ekawati LL, Tjahjono B, Setiabudy R, Sutanto I, Chand K, Ekasari T, Djoko D, Basri H, Taylor WR, Duparc S, Subekti D, Elyazar I, Noviyanti R, Sudoyo H, Baird JK. Randomized trial of primaquine hypnozoitocidal efficacy when administered with artemisinin-combined blood schizontocides for radical cure of Plasmodium vivax in Indonesia. BMC Med. 2015 Dec 11;13:294. doi: 10.1186/s12916-015-0535-9.
  PMID: 26654101
  responsible party type: Sponsor-Investigator
  investigator affiliation: Pancasila University
  investigator full name: Syamsudin Abdillah,Ph.D, Pharm D
  investigator title: Profesor Dr Syamsudin Abdillah, M.Biomed
  mesh term: Malaria
  mesh term: Malaria, Falciparum
  mesh term: Malaria, Vivax
  mesh term: Piperaquine
  mesh term: Primaquine
  mesh term: Artenimol
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: 1 year
  ipd access criteria: Sharing Access are only for research purposes.