Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-03-02 @ 4:11 AM
Study NCT ID:
NCT02408094
Status:
UNKNOWN
Last Update Posted:
2017-04-25
First Post:
2015-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening Protein Markers in Patients With Rheumatoid Arthritis and Hot-dampness and Blood Stasis Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-12-04', 'releaseDate': '2024-10-17'}], 'estimatedResultsFirstSubmitDate': '2024-10-17'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-22', 'studyFirstSubmitDate': '2015-03-31', 'studyFirstSubmitQcDate': '2015-04-02', 'lastUpdatePostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum and saliva protein markers', 'timeFrame': 'six hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis', 'Heat-dampness and blood stasis syndrome', 'Protein markers'], 'conditions': ['Arthritis, Rheumatoid']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the protein markers and to applicate those protein markers in syndrome diagnosis of hot-dampness and blood stasis syndrome in patients with RA.', 'detailedDescription': 'RA is one of the main disabling diseases in nowadays, which is an autoimmune disease with complex networks mechanism involving multiple signaling pathways and existing cross path. The investigators consider that the "heat-dampness and blood stasis" syndrome is the main syndrome and major pathogenesis for active RA, which on the base of the theory of traditional Chinese medicine and a large quantity of clinical practice, and also examined by mechanism experiments. But the material basis of this syndrome is remained unclear, lack of high specific objective basis to ensure the syndrome differentiation consistency accurately in clinical practice. Proteomic techniques study cells or the body by all the protein expression and function, thus has the potential efficient for decoding syndrome biological basis. Proteomic techniques are the most effective way to reveal the essence of TCM syndrome. The investigators will use proteomic technology to explore the protein markers and to applicate those protein markers in syndrome diagnosis of hot-dampness and blood stasis syndrome in patients with RA. With strong clinical applicability, this will reveal the scientific connotation of this syndrome, preliminarily guide the syndrome differentiation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with rheunmtoid arthritis and "heat-dampness and blood stasis" syndrome', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects are made or confirmed diagnosis according to the American College of Rheumatology criterion and "heat-dampness and blood stasis" syndrome according to Traditional Chinese Medicine.\n\nExclusion Criteria:\n\n1. Subjects have other serious diseases, such as liver and kidney disease, cerebral-cardio vascular diseases.\n2. Subjects, who belong to "non-heat-dampness and blood stasis" syndrome, have double syndrome of heat or dampness.'}, 'identificationModule': {'nctId': 'NCT02408094', 'briefTitle': 'Screening Protein Markers in Patients With Rheumatoid Arthritis and Hot-dampness and Blood Stasis Syndrome', 'organization': {'class': 'OTHER', 'fullName': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}, 'officialTitle': 'Screening Sensitive Protein Markers and Exploring Application in Syndrome Diagnosis of Hot-dampness and Blood Stasis Syndrome in Patients With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': '81403364'}}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiao Juan, Doctor', 'role': 'CONTACT', 'email': 'jiao.juan@hotmail.com', 'phone': '01088001030'}], 'facility': "Guang'anmen Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jiao Juan, Doctor', 'role': 'CONTACT', 'email': 'jiao.juan@hotmail.com', 'phone': '01088001030'}], 'overallOfficials': [{'name': 'Jiao Juan, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Natural Science Foundation of China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending physician', 'investigatorFullName': 'Juan Jiao', 'investigatorAffiliation': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-10-17', 'type': 'RELEASE'}, {'date': '2024-12-04', 'type': 'RESET'}], 'unpostedResponsibleParty': "Juan Jiao, Attending physician, Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}}}}