Efficacy of Psidii Guava's Extract For COVID-19

Covid19 Clinical Trial

Official title:

Efficacy of Psidii Guava's Extract For Mild And Symptomless Coronavirus Disease-19 (COVID-19)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04810728
• Other study ID #: PSIDII0520_COV19
• Status: Completed
• Phase: Phase 3
• Start date: June 20, 2020
• Est. completion date: January 30, 2021

Study information

• Verified date: April 2021
• Source: Faculty of Medicine Baiturrahmah University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 30, 2021
• Est. primary completion date: December 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 59 Years

Eligibility

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)

Related Conditions & MeSH terms

• Covid19

Intervention

Drug:
• Extract Psidii guava
2 Capsule Extract Psidii guava, three times daily

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

Locations

Country	Name	City	State
Indonesia	Faculty of Medicine, Baiturrahmah University	Padang	West Sumatera

Sponsors (1)

Lead Sponsor	Collaborator
Faculty of Medicine Baiturrahmah University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 days (1 week)
Secondary	Recovery rate	Recovery proportion patients with COVID-19 mild and symptompless cases at the end of study	14 days (2 weeks), maximal 28 days (4 weeks)
Secondary	Duration of seroconversion	Length of conversion detected of RT PCR RNA virus of SARS-COV-19 from positive to negative	Maximal 28 days