Covid19Phase 3NCT04810728
Efficacy of Psidii Guava's Extract For COVID-19
A Phase 3 study testing Extract Psidii guava and Standard therapy for Covid-19 patient in people with Covid19, run by Baiturrahmah University at 1 site in Indonesia.
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… Read more about this study
- Who is it for?
- Ages 13 to 59 years
- Conditions the study is for
- Covid19
- What is being tested?
- Extract Psidii guava and Standard therapy for Covid-19 patient
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIndonesia
- Study dates
- 20 Jun 2020to 30 Jan 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 59 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Not willing to join the study
- History of allergy to the research drug (extract Psidii guava)
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine, Baiturrahmah University
Padang, West Sumatera, 25586
About this study
Official title: Efficacy of Psidii Guava's Extract For Mild And Symptomless Coronavirus Disease-19 (COVID-19)
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.
Read the 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
- Being tested
- Extract Psidii guava, Standard therapy for Covid-19 patient
- Keywords
- Psidii guava extract, Coronavirus Disease-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extract Psidii guavaDrug
Also called Psidii
2 Capsule Extract Psidii guava, three times daily
Standard therapy for Covid-19 patientCombination product
(Vitamin C, Zinc, medication for clinical symptoms such as: antipyretic agent, decongestan and mucolytic.)
| Study group | Role | What they receive |
|---|---|---|
| Extract Psidii guava | Experimental | 2 Capsule of extract Psidii guava, three times daily Receives: 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.) Receives: Combination Product: Standard therapy for Covid-19 patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days (1 week)
Secondary outcomes (2)
Recovery rate
Recovery proportion patients with COVID-19 mild and symptompless cases at the end of study
Measured: 14 days (2 weeks), maximal 28 days (4 weeks)
Duration of seroconversion
Length of conversion detected of RT PCR RNA virus of SARS-COV-19 from positive to negative
Measured: Maximal 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start20 Jun 2020
- Primary completion4 Dec 2020
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baiturrahmah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fredia Heppy, MD, SpPD, FINASIM, Baiturrahmah University
- Investigators
- Fredia Heppy, MD, FINASIM, Principal investigator, Faculty of Medicine, Baiturrahmah University, Padang, West Sumatera, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810728
- Sponsor's protocol ID
- PSIDII0520_COV19
- Status last verified
- Apr 2021
- First submitted
- 16 Mar 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37009425
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Psidii Guava's Extract For Mild And Symptomless Coronavirus Disease-19 (COVID-19)
- ClinicalTrials.gov ID
- NCT04810728
- Acronym / sponsor ID
- PSIDII0520_COV19
- Conditions
- Covid19
- Keywords
- Psidii guava extract, Coronavirus Disease-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Baiturrahmah UniversityUniversity, hospital or other
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- 4 Dec 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extract Psidii guava | Experimental | Drug: Extract Psidii guava, Combination Product: Standard therapy for Covid-19 patient2 Capsule of extract Psidii guava, three times daily |
| Standard therapy | Active comparator | Combination Product: Standard therapy for Covid-19 patientStandard therapy for Covid-19 patient (vitamin C, Zinc, medication for clinical symptoms such as: antipyretic agent, decongestan and mucolytic.) |
Who may qualify
- Ages
- 13 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Not willing to join the study
- History of allergy to the research drug (extract Psidii guava)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extract Psidii guavaAlso: Psidii2 Capsule Extract Psidii guava, three times daily | Drug | Extract Psidii guava |
| Standard therapy for Covid-19 patient(Vitamin C, Zinc, medication for clinical symptoms such as: antipyretic agent, decongestan and mucolytic.) | Combination product | Extract Psidii guava, Standard therapy |
Primary outcome
Changes of inflammatory cells and marker
Time frame: 7 days (1 week)
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
2 secondary outcomes
Recovery rate
Time frame: 14 days (2 weeks), maximal 28 days (4 weeks)
Duration of seroconversion
Time frame: Maximal 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Derived from this study: PubMed 37009425Heppy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fredia Heppy, MD, FINASIM principal investigator
Faculty of Medicine, Baiturrahmah University, Padang, West Sumatera, Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Extract Psidii guava and Standard therapy for Covid-19 patient in people with Covid19, run by Baiturrahmah University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of inflammatory cells and marker (time frame: 7 days (1 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04810728, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.