Efficacy of Psidii Guava's Extract For COVID-19
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Extract Psidii guava; Standard therapy for Covid-19 patient
Intervention type(s): Drug; Combination Product
Intervention description(s): 2 Capsule Extract Psidii guava, three times daily; (Vitamin C, Zinc, medication for clinical symptoms such as: antipyretic agent, decongestan and mucolytic.)
Other intervention name(s): Psidii
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psidii guava extract; Coronavirus Disease-19