Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT07114120
Status:
RECRUITING
Last Update Posted:
2025-08-11
First Post:
2025-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study on the Treatment of Stable Bronchiectasis With Bailing Capsules Combined With Guben Kechuan Granules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001987', 'term': 'Bronchiectasis'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533614', 'term': 'bailing capsules'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 214}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2025-06-19', 'studyFirstSubmitQcDate': '2025-08-07', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of acute exacerbations during treatment and follow-up', 'timeFrame': '24 weeks and 48 weeks'}], 'secondaryOutcomes': [{'measure': 'Pulmonary function', 'timeFrame': '12, 24, 48 weeks', 'description': 'FVC'}, {'measure': 'Pulmonary function', 'timeFrame': '12, 24, 48 weeks', 'description': 'FEV1'}, {'measure': 'Pulmonary function', 'timeFrame': '12, 24 48 weeks', 'description': 'FEV1/FVC'}, {'measure': 'Pulmonary function', 'timeFrame': '12, 24, 48 weeks', 'description': 'TLC'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bronchiectasis', 'COPD']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if Bailing Capsules in combination Guben Kechuan Granules works to treat stable bronchiectasis in adults.It will also learn about the safety of Bailing Capsules in combination Guben Kechuan Granules The main questions it aims to answer are:\n\nDoes Bailing Capsules in combination Guben Kechuan Granules lower the number of acute exacerbation in patients with stable bronchiectasis? The safety of the combination of Bailing Capsules and Guben Kechuan Granules ? Researchers will compare the combination of Bailing Capsules and Guben Kechuan Granules to standard Western medical treatment to see if them works to treat stable bronchiectasis.\n\nParticipants will:\n\nTake Bailing Capsules orally (four capsules each time, three times a day) and Guben Kechuan Granules ( three times a day, 1 bag each time )on the basis of standard Western medical treatment or only standard Western medical treatment for 24 weeks Visit the clinic for checkups and tests on 4, 12, 24, 48 weeks Keep a diary of their symptoms'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18-80 years old, gender not limited;\n2. It conforms to the Western medical diagnosis of bronchiectasis;\n3. There has been no acute exacerbation or respiratory tract infection in the past 4 weeks. (Acute exacerbation is defined as the deterioration of three or more of the following six conditions: cough, changes in sputum volume, purulent sputum, breathing difficulties or exercise tolerance, fatigue or discomfort, and hemoptysis, lasting for more than 48 hours, and considered by the clinician to require treatment);\n4. There have been at least two documented acute exacerbations in the past year, prescribed by doctors and diagnosed as signs and symptoms of respiratory tract infections;\n5. Pulmonary function tests can be conducted, and there is evidence of airflow limitation when screening vital capacity (FEV1/FVC ratio \\<70%, and clinically stable at the time of entering the study);\n6. Voluntarily participate in this clinical trial and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Dry bronchiectasis mainly characterized by hemoptysis;\n2. Bronchiectasis caused by cystic fibrosis, allergic bronchopulmonary aspergillosis, etc;\n3. Previous respiratory diseases other than bronchiectasis (such as bronchial asthma, lung cancer, active pulmonary tuberculosis, interstitial lung disease, pulmonary thromboembolism and severe pneumonia, etc.);\n4. Combined with serious diseases of the heart, liver, kidneys, digestive system, blood system, etc., evaluated by the researcher, including but not limited to acute severe hepatitis, liver failure, liver cirrhosis, acute renal failure, acute myocardial infarction, heart failure, gastric perforation, gastrointestinal bleeding, gastric cancer, intestinal cancer, acute leukemia, acute aplastic anemia, etc., subject to the judgment of the researcher;\n5. Abnormal liver function was found in the patient screening examination, with the following criteria: total bilirubin \\> 1.5×ULN; ALT \\> 3×ULN; AST \\> 3×ULN;\n6. Inability to swallow the research drug;\n7. Known allergy to the test drug;\n8. Participate in other clinical trials, use other research drugs or research devices within 30 days before randomization;\n9. Women or men of childbearing age refused to use contraceptive measures during the study period;\n10. Pregnant or lactating women;\n11. Any other factors that may not be suitable for participation in clinical research as determined by the researcher;\n12. In the past year, there has been a history of alcohol abuse, drug abuse or drug abuse;\n13. Other traditional Chinese medicine treatments were used within 7 days before the use of the study drug and during the study period.'}, 'identificationModule': {'nctId': 'NCT07114120', 'briefTitle': 'Clinical Study on the Treatment of Stable Bronchiectasis With Bailing Capsules Combined With Guben Kechuan Granules', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Clinical Study on the Treatment of Stable Bronchiectasis With Bailing Capsules Combined With Guben Kechuan Granules', 'orgStudyIdInfo': {'id': '2025-0537'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Bailing Capsules orally (four capsules each time, three times a day) and Guben Kechuan Granules (1 bag each time, three times a day) on the basis of standard Western medical treatment', 'interventionNames': ['Drug: Bailing Capsules in combination Guben Kechuan Granules']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'standard Western medical treatment'}], 'interventions': [{'name': 'Bailing Capsules in combination Guben Kechuan Granules', 'type': 'DRUG', 'otherNames': ['Bailing Capsules', 'Guben Kechuan Granules'], 'description': 'Bailing Capsules (four capsules each time, three times a day) in combination Guben Kechuan Granules (1 bag each time，three times a day,)', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haibin Dai', 'role': 'CONTACT', 'email': 'HREC2013@126.com', 'phone': '0571-87783759'}], 'facility': 'The Second Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '313000', 'city': 'Huzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Zhang', 'role': 'CONTACT'}], 'facility': 'Huzhou Central Hospital', 'geoPoint': {'lat': 30.8703, 'lon': 120.0933}}, {'zip': '321000', 'city': 'Jinhua', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junwei Tu', 'role': 'CONTACT'}], 'facility': 'Jinhua Central Hospital', 'geoPoint': {'lat': 29.10678, 'lon': 119.64421}}, {'zip': '325600', 'city': 'Yueqing', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jifa Li', 'role': 'CONTACT'}], 'facility': "Yueqing People's Hospital", 'geoPoint': {'lat': 28.11941, 'lon': 120.96121}}, {'zip': '316000', 'city': 'Zhoushan', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huaiyu Zheng', 'role': 'CONTACT'}], 'facility': 'Zhoushan Hospital', 'geoPoint': {'lat': 29.98869, 'lon': 122.20488}}], 'centralContacts': [{'name': 'Haibin Dai', 'role': 'CONTACT', 'email': 'haibindai@163.com', 'phone': '（0571）87783759'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZhuZhou Central Hospital', 'class': 'OTHER'}, {'name': 'Jinhua Central Hospital', 'class': 'OTHER'}, {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, {'name': 'Affiliated Yueqing Hospital of Wenzhou Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}