Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-27 @ 10:07 PM
Study NCT ID:
NCT05798195
Status:
UNKNOWN
Last Update Posted:
2023-04-04
First Post:
2023-04-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Traditional Chinese Medicine or Low-dose Dexamethasone in COVID-19 Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 420}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-02', 'studyFirstSubmitDate': '2023-04-02', 'studyFirstSubmitQcDate': '2023-04-02', 'lastUpdatePostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung CT scan', 'timeFrame': '1 month', 'description': 'compared with base,≥90% pneumonia obsorbed'}], 'secondaryOutcomes': [{'measure': 'Lung CT scan', 'timeFrame': '3 months', 'description': 'compared with base,≥50% pneumonia obsorbed'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19 Pneumonia']}, 'descriptionModule': {'briefSummary': 'The goal of this type of clinical trial is to learn about symptomatic patients with post-COVID-19 parenchymal lung abnormalities. The main questions it aims to answer are: the efficacy and safety of low-dose dexamethasone or traditional Chinese medicine in symptomatic patients with post-COVID-19 parenchymal lung abnormalities.\n\nParticipants will be divided into three parallel groups：controlled group with conventional western medicine treatment including oxygen therapy, antibiotics, nebulization therapy, etc. dexamethasone group: dexamethasone 1.5mg/day for one week and 0.75mg/day for another week basing on conventional western medicine. Chinese medicine group: Strengthening spleen and tonifying lung decoction for 2 weeks basing on conventional western medicine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of COVID-19 pneumonia；\n* 3 to 8 weeks after the onset of the first symptoms of COVID-19 infection;\n* Modified Medical Research Council (mMRC) score ⩾2 or hypoxemia;\n* Imaging severity assessment of pneumonia: CT severity scores (CTSS):≥5；\n* Signed the informed consent.\n\nExclusion Criteria:\n\n* Participants still admitted to intensive care unit at the time of enrollment;\n* Known prior structural lung disease, including pulmonary fibrosis, severe COPD, severe bronchiectasis, and lung destruction;\n* Taking glucocorticoids or immunosuppressants because of other chronic diseases;\n* Contraindications of glucocorticoid;\n* Heart failure(NYHA III or IV);\n* Participants with renal replacement therapy;\n* Psychiatric disorders or cognitive impairments;\n* The expected survival time is less than six months due to diseases other than COVID-19 pneumonia.'}, 'identificationModule': {'nctId': 'NCT05798195', 'briefTitle': 'Traditional Chinese Medicine or Low-dose Dexamethasone in COVID-19 Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'Traditional Chinese Medicine or Low-dose Dexamethasone in Symptomatic Patients With Post-COVID-19 Parenchymal Lung Abnormalities: a Randomized Controlled Trial Three Arm, Parallel Group, Single Blind, Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '2023-ZF-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'controlled group', 'description': 'conventional western medicine treatment including oxygen therapy, antibiotics, nebulization therapy, etc.', 'interventionNames': ['Other: conventional western medicine treatment']}, {'type': 'EXPERIMENTAL', 'label': 'dexamethasone group', 'description': 'dexamethasone 1.5mg/day for one week and 0.75mg/day for another week basing on conventional western medicine.', 'interventionNames': ['Other: conventional western medicine treatment', 'Drug: Dexamethasone oral tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Chinese medicine group', 'description': 'Strengthening spleen and tonifying lung decoction for 2 weeks basing on conventional western medicine.', 'interventionNames': ['Other: conventional western medicine treatment', 'Other: Traditional Chinese medicine decoction']}], 'interventions': [{'name': 'conventional western medicine treatment', 'type': 'OTHER', 'description': 'conventional western medicine treatment only', 'armGroupLabels': ['Chinese medicine group', 'controlled group', 'dexamethasone group']}, {'name': 'Dexamethasone oral tablet', 'type': 'DRUG', 'description': 'treat with Dexamethasone for 2 weeks', 'armGroupLabels': ['dexamethasone group']}, {'name': 'Traditional Chinese medicine decoction', 'type': 'OTHER', 'description': 'treat with strengthening spleen and tonifying lung decoction for 2 weeks', 'armGroupLabels': ['Chinese medicine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wanmu Xie, Doctor', 'role': 'CONTACT', 'email': 'xiewanmu@126.com', 'phone': '86-10-84206246'}], 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Wanmu Xie, Doctor', 'role': 'CONTACT', 'email': 'xiewanmu@126.com', 'phone': '86-10-84206246'}], 'overallOfficials': [{'name': 'Zhenguo Zhai, Dcotor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Respiratory and Critical Care Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician of PCCM', 'investigatorFullName': 'Zhenguo Zhai,MD,PhD', 'investigatorAffiliation': 'China-Japan Friendship Hospital'}}}}