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Efficacy of Psidii Guava's Extract For COVID-19

F

Faculty of Medicine Baiturrahmah University

Status and phase

Completed
Phase 3

Conditions

Covid19

Treatments

Drug: Extract Psidii guava
Combination Product: Standard therapy for Covid-19 patient

Study type

Interventional

Funder types

Other

Identifiers

NCT04810728
PSIDII0520_COV19

Details and patient eligibility

About

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 8.5 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-1(RT)with an inhibition concentration of 7.2 μM compared to quercetin 0.6 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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

13 to 59 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female
  • Confirmed positive COVID-19 mild and symptomless
  • Aged 13 - 59 years
  • Willing to take part in the study and sign an informed consent

Exclusion criteria

  • Not willing to join the study
  • History of allergy to the research drug (extract Psidii guava)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 2 patient groups

Extract Psidii guava
Experimental group
Description:
2 Capsule of extract Psidii guava, three times daily
Treatment:
Drug: Extract Psidii guava
Combination Product: Standard therapy for Covid-19 patient
Standard therapy
Active Comparator group
Description:
Standard therapy for Covid-19 patient (vitamin C, Zinc, medication for clinical symptoms such as: antipyretic agent, decongestan and mucolytic.)
Treatment:
Combination Product: Standard therapy for Covid-19 patient

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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