Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-02-10 @ 10:41 PM
Study NCT ID:
NCT03228134
Status:
UNKNOWN
Last Update Posted:
2023-05-25
First Post:
2017-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study on Treatment of Chronic Persistent Bronchial Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blind trial'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All treatment group received traditional chinese medicine plus a standard anti-asthma treatment on study entry, and the control group received placebo and standard anti-asthma treatment.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-24', 'studyFirstSubmitDate': '2017-07-17', 'studyFirstSubmitQcDate': '2017-07-19', 'lastUpdatePostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asthma control rate change', 'timeFrame': 'up to 4 weeks', 'description': 'Measured the change from Baseline of asthma control rate'}], 'secondaryOutcomes': [{'measure': 'Lung function(FEV1, PEF)', 'timeFrame': 'Up to 4 weeks', 'description': 'Measured routine pulmonary ventilation function test'}, {'measure': 'FeNO', 'timeFrame': 'Up to 4 weeks', 'description': 'The fractional concentration of exhaled nitric oxide'}, {'measure': 'Blood routine examination', 'timeFrame': 'Up to 4 weeks', 'description': 'Hematological routine examination'}, {'measure': 'Liver function test', 'timeFrame': 'Up to 4 weeks', 'description': 'Simple liver function test'}, {'measure': 'Cytokine levels of induced sputum', 'timeFrame': 'Up to 4 weeks', 'description': 'Measured cytokine levels of induced sputum supernatant'}, {'measure': 'Kidney function test', 'timeFrame': 'Up to 4 weeks', 'description': 'Simple kidney function test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['treatment； bronchial asthma'], 'conditions': ['Bronchial Asthma']}, 'descriptionModule': {'briefSummary': 'Investigators aimed to evaluate the clinical efficacy of integrated traditional Chinese and Western medicine in the treatment of asthma, and to further optimize the prescription of Chinese medicine treatment.', 'detailedDescription': 'The incidence of asthma in China is high and the rate of control is low. Traditional Chinese medicine has a long history of treating asthma, and has a good clinical curative effect.The purpose of this study is to evaluate the clinical efficacy of traditional Chinese medicine in the treatment of asthma, and to further optimize the prescription of Chinese medicine treatment.\n\nIn this study, investigators recruited chronic persistent asthma participants, and gave the corresponding western medicine background treatment and traditional Chinese medicine treatment program for 28 days.Participants will undergo a physical examination, lung function, blood and sputum collection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient diagnosed with chronic persistent asthma\n* Patients had positive bronchodilator reversibility test or positive bronchial challenge test or more than 50 parts per billion of FENO before\n* Conform to the predetermined 2 TCM Syndrome Types\n* Patients who have given written informed consent\n\nExclusion Criteria:\n\n* Smoking and continuous exposure to hazardous environment\n* With fever, or severity of intermittent state, high degree of sustained, or with respiratory failure, etc.\n* Pulmonary emphysema, chronic obstructive pulmonary disease, pulmonary emphysema, pulmonary heart disease, pneumonia, lung cancer and other lung diseases\n* Patients who are allergic to therapeutic medicine'}, 'identificationModule': {'nctId': 'NCT03228134', 'briefTitle': 'Clinical Study on Treatment of Chronic Persistent Bronchial Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai University of Traditional Chinese Medicine'}, 'officialTitle': 'Clinical Study on Treatment of Chronic Persistent Bronchial Asthma With Integrated Traditional Chinese and Western Medicine', 'orgStudyIdInfo': {'id': '2017LCSY347'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hanxiao treatment group', 'description': '80 patients belongs to Hanxiao type of asthma will take Ke Chuan Liu Wei Granule oral therapy twice everyday for 28 days and receive background therapy of ICS and beta2-agonist.', 'interventionNames': ['Drug: Ke Chuan Liu Wei Granule']}, {'type': 'SHAM_COMPARATOR', 'label': 'Hanxiao control group', 'description': '80 patients belongs to Hanxiao type of asthma will take Ke Chuan Liu Wei Granule placebo oral therapy twice everyday for 28 days and receive background therapy of ICS and beta2-agonist.', 'interventionNames': ['Other: Ke Chuan Liu Wei Granule placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Xuxiao treatment group', 'description': '80 patients of deficiency type of asthma will take Yang He Ping Chuan Granule oral therapy thrice everyday for 28 days and background therapy of ICS and beta2-agonist.', 'interventionNames': ['Drug: Yang He Ping Chuan Granule']}, {'type': 'SHAM_COMPARATOR', 'label': 'Xuxiao control group', 'description': '80 patients of deficiency type of asthma will take Yang He Ping Chuan Granule placebo oral therapy thrice everyday for 28 days and background therapy of ICS and beta2-agonist.', 'interventionNames': ['Other: Yang He Ping Chuan Granule placebo']}], 'interventions': [{'name': 'Ke Chuan Liu Wei Granule', 'type': 'DRUG', 'otherNames': ['KCLW Granule'], 'description': 'Traditional Chinese Medicine', 'armGroupLabels': ['Hanxiao treatment group']}, {'name': 'Yang He Ping Chuan Granule', 'type': 'DRUG', 'otherNames': ['YHPC Granule'], 'description': 'Traditional Chinese Medicine', 'armGroupLabels': ['Xuxiao treatment group']}, {'name': 'Ke Chuan Liu Wei Granule placebo', 'type': 'OTHER', 'otherNames': ['Placebo'], 'description': 'Placebo', 'armGroupLabels': ['Hanxiao control group']}, {'name': 'Yang He Ping Chuan Granule placebo', 'type': 'OTHER', 'otherNames': ['Placebo'], 'description': 'Placebo', 'armGroupLabels': ['Xuxiao control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chuntao Yi, Master', 'role': 'CONTACT', 'email': 'yichuntao@126.com', 'phone': '+8618817338803'}], 'facility': 'Fenglin Street Community Health Service Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Taiquan Huang, Master', 'role': 'CONTACT', 'email': 'tqh957@sina.com.cn', 'phone': '+8613918375404'}], 'facility': 'Kangjian Street Community Health Service Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xin He, Master', 'role': 'CONTACT', 'email': 'hexin2050@163.com', 'phone': '+8613501903509'}], 'facility': 'Tianping Street Community Health Service Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zifeng Ma, Master', 'role': 'CONTACT', 'email': 'mzf05@126.com', 'phone': '+8618817338863'}], 'facility': 'Longhua Hospital Affiliated Shanghai University of TCM', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '201400', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fang Fang, Master', 'role': 'CONTACT', 'email': '13816856217@139.com', 'phone': '+8613816856217'}], 'facility': 'Fengxian District Hospital of TCM', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zifeng Ma, Doctor', 'role': 'CONTACT', 'email': 'mzf05@126.com', 'phone': '+8621-64385700', 'phoneExt': '1307'}, {'name': 'Zhenghui Lu, PHD', 'role': 'CONTACT', 'email': 'tcmdoctorlu@163.com', 'phone': '+8621-64385700', 'phoneExt': '1307'}], 'overallOfficials': [{'name': 'Huiyong Zhang, Director', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'tcmdoctorzhang@163.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Longhua Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}