Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06036030
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2023-09-04
Brief Title:
Combination Momordica Charantia Extract and Primaquine Againts Plasmodium Falciparum Uncomplicated and Plasmodium Vivax Uncomplicated Treatment in Manokwari West Papua
Sponsor:
Syamsudin AbdillahPhD Pharm D
Organization:
Pancasila University
Study Overview
Official Title:
Combination Momordica Charantia Extract and Primaquine Againts Plasmodium Falciparum Uncomplicated and Plasmodium Vivax Uncomplicated Treatment in Manokwari West Papua
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MCMPFPB
Brief Summary:
Comparing the efficacy of the combination treatment of bitter melon fruit extract Momordica charantia with primaquine MCPQ against the combination of dihydroartemisinin piperaquine primaquine DHPPQ 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 MCPQ and DHPPQ 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 MCPQ and DHPPQ 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 1350 mgkg body weight was initially approved by the MCPQ group and administered for 3 days 15 mg Primaquine dose single 025 mgkg 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 DHPPQ 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
The combination of 500 mg of bitter melon fruit extract Momordica charantia and 325 mg of bitter melon fruit content 1350 mgkg body weight was initially approved by the MCPQ group and administered for 3 days 15 mg Primaquine dose single 025 mgkg 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 DHPPQ 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None