Ignite Creation Date:
2025-12-24 @ 9:27 PM
Ignite Modification Date:
2026-02-19 @ 11:57 AM
Study NCT ID:
NCT04108832
Status:
COMPLETED
Last Update Posted:
2019-09-30
First Post:
2014-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Traditional Chinese Medicine Formula Liu-Wei-Die-Huang-Wan in the Treatment of Osteoarthritis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-12-06', 'releaseDate': '2019-11-18'}], 'estimatedResultsFirstSubmitDate': '2019-11-18'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-26', 'studyFirstSubmitDate': '2014-09-17', 'studyFirstSubmitQcDate': '2019-09-26', 'lastUpdatePostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Western Ontario and McMaster Universities (WOMAC)', 'timeFrame': 'week 0, week 4, week 8', 'description': 'The investigators use WOMAC to compared the difference between the week 8 and week 0'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale for pain (VAS)', 'timeFrame': 'week0, week 4 and 8', 'description': 'The investigators use VAS to compared the difference between the week 4 and week 0, week 8 and week 0'}, {'measure': 'Physicians Global Assessment to measure quality of life (PGA)', 'timeFrame': 'week0, week 4 and week 8', 'description': 'The investigators use PGA to compared the difference between the week 4 and week 0, week 8 and week 0'}, {'measure': 'Quality of life by SF-36', 'timeFrame': 'week0, week 2 and week 4', 'description': 'The investigators use SF-36 to compared the difference between the week 4 and week 0, week 2 and week 0'}, {'measure': 'High sensitivity C-reactive protein (Hs-CRP)', 'timeFrame': 'week0, week 8', 'description': 'The investigators use Hs-CRP to compared the difference between the week 8 and week 0'}, {'measure': 'Erythrocyte sedimentation rate (ESR)', 'timeFrame': 'week0, week 8', 'description': 'The investigators use ESR to compared the difference between the week 8 and week 0'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Traditional Chinese Medicine', 'Herbs', 'Liu-wei-die-Huang-Wan'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Through an eight-week randomized, double-blind, placebo-controlled clinical trials formula to evaluate Chinese herbal compound OA2 improve osteoarthritis of efficacy and safety.', 'detailedDescription': "This trial was a 8 weeks' randomized, double-blind, placebo-controlled study. The study was approved by the Institutional Review Board of Chung Shan Medical University hospital, and signed informed consent was obtained from each patient. Eighty-one patients of osteoarthritis of knees or hips were enrolled in this study. Inclusion criteria were: age 20 to 80 years; primary osteoarthritis in at least 1 knee, verified radiologically and scored (as normal, minimal, moderate or marked) for joint-space narrowing and marginal osteophytes in the medial, lateral and patellofemoral compartments; at least moderate pain during the 2 weeks before random assignment to treatment, as identified with the Western Ontario and McMaster Universities (WOMAC) LK3.0 Osteoarthritis Index pain subscale.\n\nPrimary outcome measures: WOMAC (Western Ontario and McMaster Universities) osteoarthritis index at week 4.\n\nSecondary outcome measures: WOMAC (Western Ontario and McMaster Universities) osteoarthritis index at week 2; Visual analogue scale (VAS), Quality of life by SF-36, patient global assessment (PGA), at week 2 and 4; The PGA was scored from 0 to 4 (0 representing very good); Biomarkers: Hs-CRP, ESR."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥20 years old\n* Written informed consent obtained\n* Been diagnosed with knee or hip osteoarthritis\n* The physician interpretation of X-ray identification and joint space narrowing or bone spurs confirmed\n* In randomized trials before entering if used steroids or non-steroid medications osteoarthritis stable doses required at least one week\n* The WOMAC osteoarthritis index of the degree of pain assessment in the past two weeks at least\\> 4ppm pain\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women.\n* Chemotherapy or radiation therapy in cancer patients'}, 'identificationModule': {'nctId': 'NCT04108832', 'briefTitle': 'Traditional Chinese Medicine Formula Liu-Wei-Die-Huang-Wan in the Treatment of Osteoarthritis.', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'Traditional Chinese Medicine Formula Liu-Wei-Die-Huang-Wan in the Treatment of Osteoarthritis. An Eight-Weeks Double Blind Randomized Placebo-Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': 'CS13048'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TCM OA2', 'description': 'TCM OA2 3G BID FOR 8 WEEKS', 'interventionNames': ['Drug: TCM OA2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLACEBO', 'description': 'PLACEBO', 'interventionNames': ['Drug: PLACEBO']}], 'interventions': [{'name': 'TCM OA2', 'type': 'DRUG', 'otherNames': ['LIOW WEY DIH HUANG WAN EXTRACT PILL'], 'description': 'Usage: 3g twice daily', 'armGroupLabels': ['TCM OA2']}, {'name': 'PLACEBO', 'type': 'DRUG', 'description': 'Usage: 3g twice daily', 'armGroupLabels': ['PLACEBO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '402', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Chung Shan Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Wei C- C, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chung Shan Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung Shan Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Cheng-Chung Wei', 'investigatorAffiliation': 'Chung Shan Medical University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-11-18', 'type': 'RELEASE'}, {'date': '2019-12-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Cheng-Chung Wei, Professor, Chung Shan Medical University'}}}}