Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:46 PM
Study NCT ID:
NCT06355193
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2024-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Isatidis Root and Forsythia Oral Liquid for the Treatment of Mild Cases of COVID-19: A Trial Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000588632', 'term': 'lianhuaqingwen'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 253}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-08', 'studyFirstSubmitDate': '2024-04-08', 'studyFirstSubmitQcDate': '2024-04-08', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment and symptomatic improvement effects of LGLQ', 'timeFrame': '1 month', 'description': 'LGLQ and LHQW were able to significantly reduce the duration of infection with novel coronaviruses'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Treatment of Mild Cases of COVID-19']}, 'descriptionModule': {'briefSummary': 'This study has significant implications for research, as it provides a basis for further studies on the antiviral effects of LGLQ Oral Liquid, encouraging more extensive clinical studies in larger populations and diverse age groups to validate these findings. For medical practice, the findings suggest that LGLQ can be considered an alternative treatment option for mild cases of COVID-19, especially in managing symptoms like fatigue, potentially broadening the range of effective treatments available to healthcare practitioners. In terms of policy, the demonstrated efficacy of LGLQ could lead to its inclusion in treatment guidelines for COVID-19 and other viral infections, fostering a more integrated approach combining Western medicine and Traditional Chinese Medicine in the global fight against pandemics. The insights from this study might prompt health policymakers to reassess the potential of herbal formulations in managing and treating infectious diseases and consider them in the development of future healthcare strategies and policies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* the diagnosis of SARS-Cov-2 infection confirmed by quantitative polymerase chain reaction (qPCR) test\n* aged 18 years or older\n* patients received more than 2 doses of SARS-Cov-2 vaccine\n* asymptomatic or mild at the time of hospitalization\n\nExclusion Criteria:\n\n* patients with malignant diseases, autoimmune diseases, liver and kidney diseases, blood diseases, neurological diseases, endocrine diseases and other serious diseases may affect the patient's participation in the trial or affect the results of the study\n* pregnant women, lactating mothers; allergic conditions\n* allergic to the known components of the drug\n* patients vaccinated with vaccines less than 1 shot\n* Patient does not agree to participate in this study"}, 'identificationModule': {'nctId': 'NCT06355193', 'briefTitle': 'The Use of Isatidis Root and Forsythia Oral Liquid for the Treatment of Mild Cases of COVID-19: A Trial Clinical Study', 'organization': {'class': 'OTHER', 'fullName': 'Central South University'}, 'officialTitle': 'The Use of Isatidis Root and Forsythia Oral Liquid for the Treatment of Mild Cases of COVID-19: A Trial Clinical Study', 'orgStudyIdInfo': {'id': 'MZhou'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LGLQ group', 'interventionNames': ['Drug: Langenlianqiao']}, {'type': 'EXPERIMENTAL', 'label': 'LHQW group', 'interventionNames': ['Drug: LianhuaQingWen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo control group', 'interventionNames': ['Other: placebo control group']}], 'interventions': [{'name': 'Langenlianqiao', 'type': 'DRUG', 'description': 'The data of patients with COVID-19 mild disease treated in our Hospital from November to December 2022 were collected, and the patients were divided into 100 cases of langenlianqiao(LGLQ) treatment group, 100 cases of LianhuaQingWen(LHQW) treatment group, and 53 cases of placebo control group according to the treatments they received, and the proportion of occurrence of major clinical symptoms, the time of symptom disappearance, and the number of days in hospitalization, and the duration of infection were compared among the three groups.', 'armGroupLabels': ['LGLQ group']}, {'name': 'LianhuaQingWen', 'type': 'DRUG', 'description': 'The data of patients with COVID-19 mild disease treated in our Hospital from November to December 2022 were collected, and the patients were divided into 100 cases of langenlianqiao(LGLQ) treatment group, 100 cases of LianhuaQingWen(LHQW) treatment group, and 53 cases of placebo control group according to the treatments they received, and the proportion of occurrence of major clinical symptoms, the time of symptom disappearance, and the number of days in hospitalization, and the duration of infection were compared among the three groups.', 'armGroupLabels': ['LHQW group']}, {'name': 'placebo control group', 'type': 'OTHER', 'description': 'placebo control group', 'armGroupLabels': ['placebo control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changde', 'state': 'Hunan', 'country': 'China', 'facility': 'Changde Hospital', 'geoPoint': {'lat': 29.03205, 'lon': 111.69844}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Mi Zhou', 'investigatorAffiliation': 'Central South University'}}}}