Efficacy of Psidii Guava's Extract For COVID-19

NCT04810728 | Completed Phase 3

• 1 other identifier: PSIDII0520_COV19
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Psidii guava extract; Coronavirus Disease-19

Outcome Measures

Primary Outcomes (1)

• Changes of inflammatory cells and marker

  1. Leucocyte count in mm3 2. Neutrophil count in % 3. Lymphocyte count in % 4. Monocyte count in % 5. Neutrophil-lymphocyte ratio 6. High sensitivity C reactive protein in ng/mL

  7 days (1 week)

Secondary Outcomes (2)

• Recovery rate

  14 days (2 weeks), maximal 28 days (4 weeks)

• Duration of seroconversion

  Maximal 28 days

Study Arms (2)

Extract Psidii guava

EXPERIMENTAL

2 Capsule of extract Psidii guava, three times daily

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

Standard therapy

ACTIVE COMPARATOR

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

Combination Product: Standard therapy for Covid-19 patient

Interventions

Extract Psidii guava DRUG

2 Capsule Extract Psidii guava, three times daily

Also known as: Psidii

Extract Psidii guava

Standard therapy for Covid-19 patient COMBINATION_PRODUCT

(Vitamin C, Zinc, medication for clinical symptoms such as: antipyretic agent, decongestan and mucolytic.)

Extract Psidii guava; Standard therapy

Eligibility Criteria

• Age: 13 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Faculty of Medicine Baiturrahmah University: lead

Study Sites (1)

Faculty of Medicine, Baiturrahmah University

Padang, West Sumatera, 25586, Indonesia

Location

Related Publications (1)

• Heppy F, Mulyana R, Afrainin Syah N, Tjandrawinata RR. The effect of Psidium guajava Leaves' extract for mild and asymptomatic corona virus Disease-19. Saudi Pharm J. 2023 Apr;31(4):592-596. doi: 10.1016/j.jsps.2023.02.012. Epub 2023 Mar 7.

  PMID: 37009425 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Fredia Heppy, MD, FINASIM

  Faculty of Medicine, Baiturrahmah University, Padang, West Sumatera, Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Internal Medicine, Prinsipal Investigator

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 23, 2021
• Study Start: June 20, 2020
• Primary Completion: December 4, 2020
• Study Completion: January 30, 2021
• Last Updated: April 20, 2021

Record last verified: 2021-04

Locations

ID (1)