Efficacy of Psidii Guava's Extract For COVID-19

NCT ID: NCT04810728

Last Updated: 2021-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-20
• Study Completion Date: 2021-01-30

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Extract Psidii guava

2 Capsule of extract Psidii guava, three times daily

Group Type: EXPERIMENTAL

Extract Psidii guava

Intervention Type: DRUG

2 Capsule Extract Psidii guava, three times daily

Standard therapy for Covid-19 patient

Intervention Type: COMBINATION_PRODUCT

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

Standard therapy

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

Group Type: ACTIVE_COMPARATOR

Standard therapy for Covid-19 patient

Intervention Type: COMBINATION_PRODUCT

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

Interventions

Extract Psidii guava

2 Capsule Extract Psidii guava, three times daily

Intervention Type: DRUG

Standard therapy for Covid-19 patient

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

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Psidii

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)

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Faculty of Medicine Baiturrahmah University

OTHER

Sponsor Role: lead

Responsible Party

Fredia Heppy, MD, SpPD, FINASIM

Lecturer of Internal Medicine, Prinsipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fredia Heppy, MD, FINASIM

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Faculty of Medicine, Baiturrahmah University

Padang, West Sumatera, Indonesia

Countries

Indonesia

References

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.

Reference Type: DERIVED

PMID: 37009425 (View on PubMed)

Other Identifiers

PSIDII0520_COV19

Identifier Type: -

Identifier Source: org_study_id