Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 10:09 PM
Study NCT ID:
NCT06143358
Status:
COMPLETED
Last Update Posted:
2023-11-24
First Post:
2023-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Qingkepingchuan Granules Clinical Observation of Phlegm-Heat and Lung Depletion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Qingkepingchuan Granules'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-21', 'studyFirstSubmitDate': '2023-11-16', 'studyFirstSubmitQcDate': '2023-11-16', 'lastUpdatePostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chinese Medicine Symptoms Scale', 'timeFrame': 'Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up', 'description': "Record changes in patients' TCM indicators。The scale includes cough, wheezing, shortness of breath, sputum volume, chest tightness, sputum colour, sputum quality, fever, thirst, irritability, constipation, tongue coating, and pulse. The first four items are rated 0-6, and the last nine items are rated 0-3, with higher ratings indicating poorer treatment outcomes."}, {'measure': 'COPD assessment test', 'timeFrame': 'Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up', 'description': "Record changes in the patient's condition"}, {'measure': 'breathlessness measurement using the modified British Medical Research Council', 'timeFrame': 'Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up', 'description': "Record changes in the patient's condition"}], 'secondaryOutcomes': [{'measure': '6-minute walking test', 'timeFrame': 'Before the start of treatment, 2 weeks of treatment', 'description': "Record changes in the patient's condition"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'Through the clinical observation of Qingcheng Pingxian Granules in the treatment of acute exacerbation of chronic obstructive pulmonary disease (phlegm-heat lung syndrome), (1) to evaluate the safety of Qingcheng Pingxian Granules in the acute exacerbation of chronic obstructive pulmonary disease; (2) to observe the clinical efficacy of Qingcheng Pingxian Granules in the treatment of acute exacerbation of chronic obstructive pulmonary disease, to provide an effective medication and solution for the treatment of acute exacerbation of chronic obstructive pulmonary disease, and to provide data for the development of the further application of Qingcheng Pingxian Granules.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Meet the diagnostic criteria of AECOPD.\n2. Chinese medicine diagnosis is consistent with phlegm-heat and lung depletion evidence\n3. 40 years old ≤ age ≤ 90 years old\n4. Patients who signed the informed consent form and volunteered to participate in the study\n\nExclusion Criteria:\n\n1. Combined with other primary lung diseases such as bronchial asthma, bronchiectasis, etc.\n2. Combination of serious cardiovascular, urinary, digestive, haematopoietic, endocrine metabolic system diseases, other psychiatric and neurological diseases.\n3. Pregnant or lactating patients.\n4. Allergic to the clinical trial drugs.'}, 'identificationModule': {'nctId': 'NCT06143358', 'briefTitle': 'Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Qingkepingchuan Granules Clinical Observation of Phlegm-Heat and Lung Depletion', 'organization': {'class': 'OTHER', 'fullName': 'Beijing University of Chinese Medicine'}, 'officialTitle': 'Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Qingkepingchuan Granules Clinical Observation of Phlegm-Heat and Lung Depletion', 'orgStudyIdInfo': {'id': 'SY-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment group', 'description': 'Qingkepingchuan Granules+Conventional basic therapy', 'interventionNames': ['Drug: Qingkepingchuan Granules']}, {'type': 'OTHER', 'label': 'control subjects', 'description': 'Conventional basic therapy', 'interventionNames': ['Other: conventional treatment']}], 'interventions': [{'name': 'Qingkepingchuan Granules', 'type': 'DRUG', 'description': 'Qingkepingchuan Granules,Take it three times a day with water after meals.', 'armGroupLabels': ['treatment group']}, {'name': 'conventional treatment', 'type': 'OTHER', 'description': 'Oxygen intake, selection of appropriate antibiotics based on lab results, and other treatments', 'armGroupLabels': ['control subjects']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Beijing University of Chinese Medicine', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhang Zhijie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Zhang Zhijie', 'investigatorAffiliation': 'Beijing University of Chinese Medicine'}}}}