Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-31 @ 5:19 PM
Study NCT ID:
NCT01293734
Status:
COMPLETED
Last Update Posted:
2011-02-11
First Post:
2011-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research on Traditional Chinese Medicine (TCM) Clinical Treatment of the Acute Episode of 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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-10', 'studyFirstSubmitDate': '2011-02-10', 'studyFirstSubmitQcDate': '2011-02-10', 'lastUpdatePostDateStruct': {'date': '2011-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'primary Symptom', 'timeFrame': '30 days', 'description': 'Symptom: wheezing, cough, choking'}, {'measure': 'physical sign', 'timeFrame': '30 days', 'description': 'physical sign: wheezing sound'}, {'measure': 'assistant examination', 'timeFrame': '30 days', 'description': 'Pulmonary function: mend matters of FEV1, PEF, FEV1/FVC'}], 'secondaryOutcomes': [{'measure': 'Secondary Symptom', 'timeFrame': '30 days', 'description': 'Symptom: expectoration, fever, Aversion to wind and cold'}, {'measure': 'physical sign', 'timeFrame': '30 days', 'description': 'physical sign: tongue appearance and Pulse condition'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bronchial asthma', 'cold type', 'heat type', 'Asthenia type', 'TCM syndrome', 'symptoms', 'physical signs'], 'conditions': ['Bronchial Asthma']}, 'descriptionModule': {'briefSummary': 'Bronchial asthma is a common disease and frequently encountered disease of respiratory apparatus. It has very complex mechanism and multiple inducing factors. This study will focus on a new Chinese therapy on Bronchial asthma, analyzing the treatment mechanism of internal and external use, based on Traditional Chinese Medicine (TCM) theory and clinical practice. The study will also investigate the efficacy of the Chinese drugs and treatments on Bronchial asthma, and provide an effective therapy for this disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 to 65 years old;\n* Patients with mild-to-moderate bronchial asthma on attacking stage;\n* Without cardiopulmonary or other complications;\n* To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome differentiation;\n* Informed consent form is required to be signed.\n\nExclusion Criteria:\n\n* Older than 65 years or younger than 18 years old;\n* Pregnant woman or suckling period woman;\n* Patients combine serious primary disease in liver, renal, cardiovascular and cerebrovascular, hemopoietic system diseases,or psychosis.\n* Severe levels of disease is between severe and critical extent. Combine Pulmonary Heart Disease or respiratory failure;\n* Irritable the physique, or allergic to the given composition of drugs in this research;\n* Patients who are in the process of other clinical research.'}, 'identificationModule': {'nctId': 'NCT01293734', 'briefTitle': 'Research on Traditional Chinese Medicine (TCM) Clinical Treatment of the Acute Episode of Bronchial Asthma.', 'organization': {'class': 'OTHER', 'fullName': 'Liaoning University of Traditional Chinese Medicine'}, 'orgStudyIdInfo': {'id': 'sygzwu'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cold type', 'description': 'To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in cold type', 'interventionNames': ['Other: warming lung and relieving asthmatic granule and Securing origin and warming lung emplastrum']}, {'type': 'EXPERIMENTAL', 'label': 'heat type', 'description': 'To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in heat type.', 'interventionNames': ['Other: clearing lung and relieving asthmatic granule and securing origin and clearing lung emplastrum']}, {'type': 'EXPERIMENTAL', 'label': 'Asthenia type', 'description': 'To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in Asthenia type.', 'interventionNames': ['Other: securing origin and relieving asthmatic granule and securing origin and nourishing lung emplastrum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Western medicine control group', 'interventionNames': ['Drug: Theophylline Sustained-release Tablets and budesonide suspension']}], 'interventions': [{'name': 'warming lung and relieving asthmatic granule and Securing origin and warming lung emplastrum', 'type': 'OTHER', 'description': 'warming lung and relieving asthmatic granule:once 1 bag, 3 times a day. Securing origin and warming lung emplastrum: paste on acupuncture point and take the emplastrum down after 3 hours, once a day', 'armGroupLabels': ['cold type']}, {'name': 'clearing lung and relieving asthmatic granule and securing origin and clearing lung emplastrum', 'type': 'OTHER', 'description': 'clearing lung and relieving asthmatic granule: once 1 bag, 3 times a day. securing origin and clearing lung emplastrum: paste on acupuncture point and take the emplastrum down after 3 hours, once a day', 'armGroupLabels': ['heat type']}, {'name': 'securing origin and relieving asthmatic granule and securing origin and nourishing lung emplastrum', 'type': 'OTHER', 'description': 'securing origin and relieving asthmatic granule: once 1 bag, 3 times a day. securing origin and nourishing lung emplastrum: paste on acupuncture point and take the emplastrum down after 3 hours, once a day', 'armGroupLabels': ['Asthenia type']}, {'name': 'Theophylline Sustained-release Tablets and budesonide suspension', 'type': 'DRUG', 'description': 'Theophylline Sustained-release Tablets 0.2g a time, twice a day. budesonide suspension for inhalation 100ug, twice a day', 'armGroupLabels': ['Western medicine control group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liaoning University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shenyang Huanggu District Central Hospital', 'class': 'UNKNOWN'}, {'name': 'Benxi City hospital of Chinese medicine', 'class': 'OTHER'}, {'name': 'Anshan Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Zhenwu Guo', 'oldOrganization': 'No.2 Affiliated Hospital of Liaoning University of Traditional Chinese Medicine'}}}}