Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2026-02-25 @ 11:48 PM
Study NCT ID:
NCT02770950
Status:
COMPLETED
Last Update Posted:
2018-11-20
First Post:
2016-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zushima Plaster for Treating Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-01-09', 'releaseDate': '2024-11-23'}, {'resetDate': '2025-05-01', 'releaseDate': '2025-04-13'}], 'estimatedResultsFirstSubmitDate': '2024-11-23'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 396}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-19', 'studyFirstSubmitDate': '2016-05-02', 'studyFirstSubmitQcDate': '2016-05-10', 'lastUpdatePostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the change of Visual Analogue Scale (VAS) pain score from baseline to posttreatment', 'timeFrame': 'Week 2.'}], 'secondaryOutcomes': [{'measure': "the change of Patient's global assessment of disease activity from baseline to posttreatment", 'timeFrame': 'Week 2.'}, {'measure': 'the change of WOMAC Osteoarthritis Index from baseline to posttreatment', 'timeFrame': 'Week 2.'}, {'measure': 'the change of Short Form 36 Questionnaire (SF-36) score from baseline to posttreatment', 'timeFrame': 'Week 2.', 'description': 'The SF-36 is a generic instrument to assess health-related quality of life. It consists of 36 questions and assesses 8 dimensions: physical functioning, role physical, pain index, general health, vitality, social functioning, role emotional, and mental health index. It also provides 2 summary measures of physical and mental components. The SF-36 score ranges from 0 to 100, with higher scores indicating better health status.'}, {'measure': 'the change of Erythrocyte Sedimentation rate (ESR) from baseline to posttreatment', 'timeFrame': 'Week 2.', 'description': 'ESR, also called a sedimentation rate, is the rate at which red blood cells sediment in a period of one hour. It is a non-specific measure of inflammation.'}, {'measure': 'the change of C-reactive protein (CRP) from baseline to posttreatment', 'timeFrame': 'Week 2.'}, {'measure': 'the change of knee musculoskeletal ultrasound (MSUS) from baseline to posttreatment', 'timeFrame': 'Week 2.', 'description': 'MSUS had wisely using in rheumatology practice and research. MSUS includes synovitis classification, synovial hyperplasia classification, articular cavity effusion and bone erosion classification. Specific as follows: Synovitis classification: 0 level, no doppler signal; level 1: three independent point or 2 successive or 1 and 2 in independent dot doppler signal; level 2: doppler signal \\< 50% of the synovial membrane area; level 3 doppler signal is the synovium in \\> 50% of the area. Synovial hyperplasia classification: 0 level, no synovial hyperplasia; level 1: synovial hyperplasia of mild, not more than bone surface high attachment; level 2: synovial hyperplasia more than bone surface high wire, but not more than the backbone; level 3: synovial hyperplasia more than bone surface peak wires, and extends along the backbone of the side. Articular cavity effusion and bone erosion classification: adopt binary evaluation, namely 0: normal, 1: abnormal.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Knee Osteoarthritis'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to further evaluate the clinical efficacy and safety of Zushima plaster for patients in knee osteoarthrosis post-marketing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 40-75;\n* Unilateral or bilateral knee OA, confirmed radiographically;\n* Patients taking oral NSAIDs prior to the breakthrough period will be permitted;\n* VAS pain score is or above 20mm.\n\nExclusion Criteria:\n\n* Knee is swollen and hot;\n* Allergic to any ingredient in Girald Daphne Bark Plaster (Girald Daphne Bark, Lithargite, Linseed oil, Red lead) ;\n* Congestive Heart Failure and Edema;\n* Advanced renal disease;\n* Knee joint skin is burst or skin disease or allergies.'}, 'identificationModule': {'nctId': 'NCT02770950', 'briefTitle': 'Zushima Plaster for Treating Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}, 'officialTitle': 'Zushima Plaster for Patients in Knee Osteoarthritis: a Random, Positive Drug Controlled, Multi-center Clinical Research', 'orgStudyIdInfo': {'id': '81758'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High dose group', 'description': 'High dose of Zushima plaster: a piece of Zushima plaster will be used topically for each knee for 24h per day.\n\nEligible subjects will use a piece of Zushima plaster topically for each knee for 24h per day.', 'interventionNames': ['Drug: Zushima plaster with high dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low dose group', 'description': 'Low dose of Zushima plaster: a piece of Zushima plaster will be used topically for each knee for 12h per day.\n\nEligible subjects will use a piece of Zushima plaster topically for each knee for 12h per day.', 'interventionNames': ['Drug: Zushima plaster with low dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Controlled group', 'description': 'Indometacin Cataplasms will be used topically on the knee for 24h per day', 'interventionNames': ['Drug: Indometacin Cataplasms']}], 'interventions': [{'name': 'Zushima plaster with high dose', 'type': 'DRUG', 'description': 'Patients in high dose Zushima plaster group will use Zushima plaster topically on knee(s) for 24h per day.', 'armGroupLabels': ['High dose group']}, {'name': 'Zushima plaster with low dose', 'type': 'DRUG', 'description': 'Patients in low dose Zushima plaster group will use Zushima plaster topically on knee(s) for 12h per day.', 'armGroupLabels': ['Low dose group']}, {'name': 'Indometacin Cataplasms', 'type': 'DRUG', 'description': 'Patients in Indometacin Cataplasms group will use Indometacin Cataplasms on knee(s)for 24h per day.', 'armGroupLabels': ['Controlled group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Guang'anmen Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Quan Jiang, MD. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rheumatology Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences", 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'Beijing Hospital', 'class': 'OTHER_GOV'}, {'name': 'Beijing Jishuitan Hospital', 'class': 'OTHER'}, {'name': 'Beijing Shijitan Hospital, Capital Medical University', 'class': 'OTHER'}, {'name': 'Shanghai Municipal Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'Gansu Provincial Hospital', 'class': 'OTHER'}, {'name': 'General Hospital of Beijing Military Area', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Doctor', 'investigatorFullName': 'Juan Jiao', 'investigatorAffiliation': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-11-23', 'type': 'RELEASE'}, {'date': '2025-01-09', 'type': 'RESET'}, {'date': '2025-04-13', 'type': 'RELEASE'}, {'date': '2025-05-01', 'type': 'RESET'}], 'unpostedResponsibleParty': "Juan Jiao, Attending Doctor, Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}}}}