Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04810728
Status:
COMPLETED
Last Update Posted:
2021-04-20
First Post:
2021-03-16
Brief Title:
Efficacy of Psidii Guavas Extract For COVID-19
Sponsor:
Faculty of Medicine Baiturrahmah University
Organization:
Faculty of Medicine Baiturrahmah University
Study Overview
Official Title:
Efficacy of Psidii Guavas Extract For Mild And Symptomless Coronavirus Disease-19 COVID-19
Status:
COMPLETED
Status Verified Date:
2021-04
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:
None
Brief Summary:
This study was an experimental randomized clinical trial with a parallel design with aims were seeing the effectiveness of extracted Psidii guava on white blood cells WBCs count neutrophil lymphocyte monocyte neutrophil-lymphocyte ratio NLR high sensitive C reactive protein hs-CRP proportion and duration COVID-19 seroconversion subjects compared to controls
One of the herbs standardized that was commonly used in Indonesia is extracted Psidii guava which is known as a guava leaf extract Extract Psidii guava contains chemical substances saponins oleanolic acid xylopyranoside flavonoids quercetin arabinopyranoside and Guaijavarin The Previous study on Psidii guava stated that guava leaves contain lots of flavonoids especially quercetin An in vitro study of dengue virus type 2 found that quercetin significantly inhibited the activity of the DEN-2 virus while other flavonoids looked weaker On the other hand in an in vitro test of glycosylated flavonoids from Psidium Geunesse which is a guava leaf from Brazil received the use of flavonoids in Psidium Geunesse to inhibit HIV-1 virus activity with a 50 inhibition concentration of about 85 μg ml compared to single active substances Quercetin with a 50 inhibitory concentration of about 53μg ml These flavonoids also inhibited the enzyme reverse transcriptase HIV-1RTwith an inhibition concentration of 72 μM compared to quercetin 06 μM single Another study found that quercetin in Psidii guava inhibits RNA polymerase which is important in dengue virus replication In addition quercetin can inhibit protease enzyme helicase domain and viral ATPase enzyme
There is an antiviral effect based on limited in vitro studies but with quite a lot of literature studies and considering that there are no effective antiviral drugs against COVID-19 especially mild and moderate cases also considering the length of healing time for patients COVID-19 with the risk of isolation For a long time with various consequences researchers tried to examine the effectiveness of extract Psidii guava inpatients COVID-19 at the quarantine location of the West Sumatra Provincial Government Extract Psidii guava is hypothesized to improve WBCs neutrophil lymphocyte monocyte NLR hs-CRP level to increase proportion and shorten the duration of COVID-19 seroconversion in mild and symptomless cases
One of the herbs standardized that was commonly used in Indonesia is extracted Psidii guava which is known as a guava leaf extract Extract Psidii guava contains chemical substances saponins oleanolic acid xylopyranoside flavonoids quercetin arabinopyranoside and Guaijavarin The Previous study on Psidii guava stated that guava leaves contain lots of flavonoids especially quercetin An in vitro study of dengue virus type 2 found that quercetin significantly inhibited the activity of the DEN-2 virus while other flavonoids looked weaker On the other hand in an in vitro test of glycosylated flavonoids from Psidium Geunesse which is a guava leaf from Brazil received the use of flavonoids in Psidium Geunesse to inhibit HIV-1 virus activity with a 50 inhibition concentration of about 85 μg ml compared to single active substances Quercetin with a 50 inhibitory concentration of about 53μg ml These flavonoids also inhibited the enzyme reverse transcriptase HIV-1RTwith an inhibition concentration of 72 μM compared to quercetin 06 μM single Another study found that quercetin in Psidii guava inhibits RNA polymerase which is important in dengue virus replication In addition quercetin can inhibit protease enzyme helicase domain and viral ATPase enzyme
There is an antiviral effect based on limited in vitro studies but with quite a lot of literature studies and considering that there are no effective antiviral drugs against COVID-19 especially mild and moderate cases also considering the length of healing time for patients COVID-19 with the risk of isolation For a long time with various consequences researchers tried to examine the effectiveness of extract Psidii guava inpatients COVID-19 at the quarantine location of the West Sumatra Provincial Government Extract Psidii guava is hypothesized to improve WBCs neutrophil lymphocyte monocyte NLR hs-CRP level to increase proportion and shorten the duration of COVID-19 seroconversion in mild and symptomless cases
Detailed Description:
There will be 2 groups of treatment each group will consist of 45 subjects with the treatment regimens maximal for 4 weeks
The treatment I 2 capsules of Extract Psidii guava three times daily Treatment II standard therapy for Covid-19 patient vitamin C Zink medication for clinical symptoms such as antipyretic agent decongestant and mucolytic
The eligible subjects will be randomly allocated to receive study medication Treatment 1 or Treatment 2 for 7 days if the result swab after treatment still positive patients will be given extract Psidii guava capsule with the same dose till maximal 4 weeks Treatment Group 1 will receive 2 capsules of Extract Psidii guava three times daily While Treatment Group 2 will receive the standard therapy for Covid-19 patient
Subjects will be evaluated for treatment efficacy at baseline 7 days after treatment and 28 days 4 weeks treatment The demographic profile such as age and sex will be measured at baseline White blood cells count neutrophil lymphocyte monocyte NLR hs-CRP level at baseline and 7 days after treatment while proportion and duration COVID-19 seroconversion will be measured
The treatment I 2 capsules of Extract Psidii guava three times daily Treatment II standard therapy for Covid-19 patient vitamin C Zink medication for clinical symptoms such as antipyretic agent decongestant and mucolytic
The eligible subjects will be randomly allocated to receive study medication Treatment 1 or Treatment 2 for 7 days if the result swab after treatment still positive patients will be given extract Psidii guava capsule with the same dose till maximal 4 weeks Treatment Group 1 will receive 2 capsules of Extract Psidii guava three times daily While Treatment Group 2 will receive the standard therapy for Covid-19 patient
Subjects will be evaluated for treatment efficacy at baseline 7 days after treatment and 28 days 4 weeks treatment The demographic profile such as age and sex will be measured at baseline White blood cells count neutrophil lymphocyte monocyte NLR hs-CRP level at baseline and 7 days after treatment while proportion and duration COVID-19 seroconversion will be measured
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