Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT05778318
Status:
UNKNOWN
Last Update Posted:
2023-05-11
First Post:
2023-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Lianhua Qingwen in Treating Patients Infected With the Omicron Variant of the COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-09', 'studyFirstSubmitDate': '2023-03-20', 'studyFirstSubmitQcDate': '2023-03-20', 'lastUpdatePostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disappearance rate of symptoms', 'timeFrame': 'two weeks', 'description': 'Disappearance rate of symptoms (fever, fatigue, cough)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19 Pneumonia']}, 'descriptionModule': {'briefSummary': 'A retrospective analysis was conducted on patients infected with the Omicron variant of COVID-19 diagnosed from August 2022 to now. Patients were divided into observation groups and control groups according to whether or not oral Lianhua Qingwen granules were used. Through data analysis and follow-up, the effectiveness of Lianhua Qingwen in treating patients infected with the Omicron variant of COVID-19 was discussed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '① For patients infected with the Omicron variant of COVID-19, the diagnostic criteria are confirmed cases of COVID-19 and clinical classification according to the diagnostic criteria of Prevention and Control Protocol for Novel Coronavirus Pneumonia (Trial Eighth Edition) issued by the National Health and Construction Commission; ② The clinical symptoms were classified as mild or ordinary; ③ They have been vaccinated against the COVID-19.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For patients infected with the Omicron variant, the diagnostic criteria are confirmed cases of COVID-19 and clinical classification according to the diagnostic criteria of Prevention and Control Protocol for COVID-19 (Trial Eighth Edition) issued by the National Health and Construction Commission.\n* The clinical symptoms were classified as mild or ordinary.\n* They have been vaccinated against the COVID-19.\n\nExclusion Criteria:\n\n* Patients receiving antiviral or antibiotic drugs\n* Severe and critical patients with COVID-19.\n* Patients with chronic respiratory diseases, bacterial infections of the respiratory system, and other respiratory diseases affecting the study.\n* Patients with serious primary diseases of the heart, brain, lung, liver, kidney, and hematopoietic systems, as well as mental diseases.\n* Allergic reaction to Lianhua Qingwen granules.\n* Excluded patients treated with the same drug as Lianhua Qingwen.'}, 'identificationModule': {'nctId': 'NCT05778318', 'briefTitle': 'Efficacy of Lianhua Qingwen in Treating Patients Infected With the Omicron Variant of the COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Qianfoshan Hospital'}, 'officialTitle': 'Efficacy of Lianhua Qingwen in Treating Patients Infected With the Omicron Variant of the COVID-19', 'orgStudyIdInfo': {'id': 'YXLL-KY-2022(095)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': 'Patients without Lianhua Qingwen treatment.', 'interventionNames': ['Other: The group of patients who did not receive Lianhua Qingwen orally']}, {'label': 'Observation Group', 'description': 'Patients with Lianhua Qingwen treatment.', 'interventionNames': ['Drug: The group of patients who received Lianhua Qingwen orally']}], 'interventions': [{'name': 'The group of patients who received Lianhua Qingwen orally', 'type': 'DRUG', 'description': 'Lianhua Qingwen Granules: oral. One bag at a time, three times a day. The course of treatment for mild and ordinary cases of novel coronavirus pneumonia is 7-10 days.', 'armGroupLabels': ['Observation Group']}, {'name': 'The group of patients who did not receive Lianhua Qingwen orally', 'type': 'OTHER', 'description': 'The group of patients who did not receive Lianhua Qingwen orally.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qian Qi, Dr.', 'role': 'CONTACT', 'email': 'qiqianqlh@163.com', 'phone': '+86 13706380314'}], 'facility': 'Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Qian Qi, Dr.', 'role': 'CONTACT', 'email': 'qiqianqlh@163.com', 'phone': '+86 13706380314'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qianfoshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Qian Qi', 'investigatorAffiliation': 'Qianfoshan Hospital'}}}}