Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 3:24 PM
Study NCT ID:
NCT04810728
Status:
COMPLETED
Last Update Posted:
2021-04-20
First Post:
2021-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Psidii Guava's Extract For COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-17', 'studyFirstSubmitDate': '2021-03-16', 'studyFirstSubmitQcDate': '2021-03-20', 'lastUpdatePostDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of inflammatory cells and marker', 'timeFrame': '7 days (1 week)', 'description': '1. Leucocyte count in mm3\n2. Neutrophil count in %\n3. Lymphocyte count in %\n4. Monocyte count in %\n5. Neutrophil-lymphocyte ratio\n6. High sensitivity C reactive protein in ng/mL'}], 'secondaryOutcomes': [{'measure': 'Recovery rate', 'timeFrame': '14 days (2 weeks), maximal 28 days (4 weeks)', 'description': 'Recovery proportion patients with COVID-19 mild and symptompless cases at the end of study'}, {'measure': 'Duration of seroconversion', 'timeFrame': 'Maximal 28 days', 'description': 'Length of conversion detected of RT PCR RNA virus of SARS-COV-19 from positive to negative'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psidii guava extract', 'Coronavirus Disease-19'], 'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '37009425', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.\n\nOne 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.\n\nThere 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.', 'detailedDescription': 'There will be 2 groups of treatment; each group will consist of 45 subjects with the treatment regimens maximal for 4 weeks.\n\nThe 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).\n\nThe 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.\n\nSubjects 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '59 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n* Confirmed positive COVID-19 mild and symptomless\n* Aged 13 - 59 years\n* Willing to take part in the study and sign an informed consent\n\nExclusion Criteria:\n\n* Not willing to join the study\n* History of allergy to the research drug (extract Psidii guava)'}, 'identificationModule': {'nctId': 'NCT04810728', 'briefTitle': "Efficacy of Psidii Guava's Extract For COVID-19", 'organization': {'class': 'OTHER', 'fullName': 'Faculty of Medicine Baiturrahmah University'}, 'officialTitle': "Efficacy of Psidii Guava's Extract For Mild And Symptomless Coronavirus Disease-19 (COVID-19)", 'orgStudyIdInfo': {'id': 'PSIDII0520_COV19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Extract Psidii guava', 'description': '2 Capsule of extract Psidii guava, three times daily', 'interventionNames': ['Drug: Extract Psidii guava', 'Combination Product: Standard therapy for Covid-19 patient']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard therapy', 'description': 'Standard therapy for Covid-19 patient (vitamin C, Zinc, medication for clinical symptoms such as: antipyretic agent, decongestan and mucolytic.)', 'interventionNames': ['Combination Product: Standard therapy for Covid-19 patient']}], 'interventions': [{'name': 'Extract Psidii guava', 'type': 'DRUG', 'otherNames': ['Psidii'], 'description': '2 Capsule Extract Psidii guava, three times daily', 'armGroupLabels': ['Extract Psidii guava']}, {'name': 'Standard therapy for Covid-19 patient', 'type': 'COMBINATION_PRODUCT', 'description': '(Vitamin C, Zinc, medication for clinical symptoms such as: antipyretic agent, decongestan and mucolytic.)', 'armGroupLabels': ['Extract Psidii guava', 'Standard therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25586', 'city': 'Padang', 'state': 'West Sumatera', 'country': 'Indonesia', 'facility': 'Faculty of Medicine, Baiturrahmah University', 'geoPoint': {'lat': -0.94924, 'lon': 100.35427}}], 'overallOfficials': [{'name': 'Fredia Heppy, MD, FINASIM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Baiturrahmah University, Padang, West Sumatera, Indonesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculty of Medicine Baiturrahmah University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Internal Medicine, Prinsipal Investigator', 'investigatorFullName': 'Fredia Heppy, MD, SpPD, FINASIM', 'investigatorAffiliation': 'Faculty of Medicine Baiturrahmah University'}}}}