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Efficacy of Psidii Guava's Extract For COVID-19

Primary Purpose

Covid19

Status
Completed
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Extract Psidii guava
Standard therapy for Covid-19 patient
Sponsored by
Faculty of Medicine Baiturrahmah University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Psidii guava extract, Coronavirus Disease-19

Eligibility Criteria

13 Years - 59 Years (Child, Adult)All SexesDoes not accept 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)

Sites / Locations

  • Faculty of Medicine, Baiturrahmah University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Extract Psidii guava

Standard therapy

Arm Description

2 Capsule of extract Psidii guava, three times daily

Standard therapy for Covid-19 patient (vitamin C, Zinc, medication for clinical symptoms such as: antipyretic agent, decongestan and mucolytic.)

Outcomes

Primary Outcome Measures

Changes of inflammatory cells and marker
Leucocyte count in mm3 Neutrophil count in % Lymphocyte count in % Monocyte count in % Neutrophil-lymphocyte ratio High sensitivity C reactive protein in ng/mL

Secondary Outcome Measures

Recovery rate
Recovery proportion patients with COVID-19 mild and symptompless cases at the end of study
Duration of seroconversion
Length of conversion detected of RT PCR RNA virus of SARS-COV-19 from positive to negative

Full Information

First Posted
March 16, 2021
Last Updated
April 17, 2021
Sponsor
Faculty of Medicine Baiturrahmah University
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1. Study Identification

Unique Protocol Identification Number
NCT04810728
Brief Title
Efficacy of Psidii Guava's Extract For COVID-19
Official Title
Efficacy of Psidii Guava's Extract For Mild And Symptomless Coronavirus Disease-19 (COVID-19)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 20, 2020 (Actual)
Primary Completion Date
December 4, 2020 (Actual)
Study Completion Date
January 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculty of Medicine Baiturrahmah University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Psidii guava extract, Coronavirus Disease-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extract Psidii guava
Arm Type
Experimental
Arm Description
2 Capsule of extract Psidii guava, three times daily
Arm Title
Standard therapy
Arm Type
Active Comparator
Arm Description
Standard therapy for Covid-19 patient (vitamin C, Zinc, medication for clinical symptoms such as: antipyretic agent, decongestan and mucolytic.)
Intervention Type
Drug
Intervention Name(s)
Extract Psidii guava
Other Intervention Name(s)
Psidii
Intervention Description
2 Capsule Extract Psidii guava, three times daily
Intervention Type
Combination Product
Intervention Name(s)
Standard therapy for Covid-19 patient
Intervention Description
(Vitamin C, Zinc, medication for clinical symptoms such as: antipyretic agent, decongestan and mucolytic.)
Primary Outcome Measure Information:
Title
Changes of inflammatory cells and marker
Description
Leucocyte count in mm3 Neutrophil count in % Lymphocyte count in % Monocyte count in % Neutrophil-lymphocyte ratio High sensitivity C reactive protein in ng/mL
Time Frame
7 days (1 week)
Secondary Outcome Measure Information:
Title
Recovery rate
Description
Recovery proportion patients with COVID-19 mild and symptompless cases at the end of study
Time Frame
14 days (2 weeks), maximal 28 days (4 weeks)
Title
Duration of seroconversion
Description
Length of conversion detected of RT PCR RNA virus of SARS-COV-19 from positive to negative
Time Frame
Maximal 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fredia Heppy, MD, FINASIM
Organizational Affiliation
Faculty of Medicine, Baiturrahmah University, Padang, West Sumatera, Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Baiturrahmah University
City
Padang
State/Province
West Sumatera
ZIP/Postal Code
25586
Country
Indonesia

12. IPD Sharing Statement

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Efficacy of Psidii Guava's Extract For COVID-19

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