Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-01-13 @ 3:24 AM
Study NCT ID:
NCT04267432
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2020-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Assessment of TCI633 Probiotics on Pain Relief and Functional Improvement in Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-10', 'studyFirstSubmitDate': '2020-01-06', 'studyFirstSubmitQcDate': '2020-02-10', 'lastUpdatePostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'KL Grade (evaluated by doctor)', 'timeFrame': 'Change from baseline at 6 months', 'description': 'Pain relief and functional improvement in osteoarthritis'}, {'measure': 'WOMAC™ Osteoarthritis Index', 'timeFrame': 'Change from baseline at 6 months', 'description': 'The questionnaire includes three-part: i) join pain (five questions); ii) joint stiffness (two questions); and, iii) physical functions of joints (seventeen questions). Each question is scored 0-4. Low to high WOMAC scores represent slight to severe OA symptoms. The lower scores mean a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Blood C-terminal telopeptide of collagen type II (CTX-II) level', 'timeFrame': 'Change from baseline at 6 months', 'description': 'To measure the level of CTX-II in blood'}, {'measure': 'Blood C-reactive protein (CRP) level', 'timeFrame': 'Change from baseline at 6 months', 'description': 'To measure the level of CRP in blood'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'To assess TCI633 probiotics on pain relief and functional improvement in osteoarthritis', 'detailedDescription': 'This is a double-blind and randomized study. Subjects are informed to consume the samples before meals in the morning every day. The clinical and radiological diagnosis of osteoarthritis of the knee is evaluated by the doctor. The blood samples and questionnaires are collected at every visit of the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Osteoarthritis patients with joint pain or discomfort (diagnosed by the physician for severe classification of the Kellgren-Lawrence Grade 1-3)\n2. Without heart, liver, kidney, endocrine and other major organic diseases (patient return)\n\nExclusion criteria\n\n1. With heart, liver (GOT and GPT values are 3-fold higher than the standard maximum), kidney (estimated creatinine clearance less than 25 mL/min), endocrine and other major organic diseases (patient return)\n2. People with mental illness'}, 'identificationModule': {'nctId': 'NCT04267432', 'briefTitle': 'The Assessment of TCI633 Probiotics on Pain Relief and Functional Improvement in Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'TCI Co., Ltd.'}, 'officialTitle': 'The Assessment of TCI633 Probiotics on Pain Relief and Functional Improvement in Osteoarthritis', 'orgStudyIdInfo': {'id': '201703132MSC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'TCI633', 'description': 'Testing product', 'interventionNames': ['Dietary Supplement: TCI633']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Type 2 collagen', 'description': 'Known drug for OA', 'interventionNames': ['Drug: Type 2 collagen']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Blank', 'armGroupLabels': ['Placebo']}, {'name': 'TCI633', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Probiotics', 'armGroupLabels': ['TCI633']}, {'name': 'Type 2 collagen', 'type': 'DRUG', 'description': 'Positive control group', 'armGroupLabels': ['Type 2 collagen']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Ting-Ming Wang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TCI Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}