Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-02-27 @ 10:05 AM
Study NCT ID:
NCT03690232
Status:
UNKNOWN
Last Update Posted:
2018-10-11
First Post:
2018-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraarticular Glucose Versus Hyaluronic Acid Injection for Knee Osteoarthrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'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', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'outcomes assessor and participant do not know the treatment patient received.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study in the first year is a prospective, randomized controlled, double-blind study. The enrolled patients were randomly divided into two groups: the intraarticular glucose group and the intraarticular HA group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-09', 'studyFirstSubmitDate': '2018-09-09', 'studyFirstSubmitQcDate': '2018-09-27', 'lastUpdatePostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': '12 weeks', 'description': 'The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales'}], 'secondaryOutcomes': [{'measure': 'Lequesne index', 'timeFrame': '0,6,12 weeks', 'description': 'The Lequesne Index is a 10-question survey given to patients with osteoarthritis of the knee. It has five questions pertaining to pain or discomfort, 1 question dealing with maximum distance walked, and four questions about activities of daily living'}, {'measure': 'visual analogue scale (VAS)', 'timeFrame': '0,6,12 weeks', 'description': 'pain intensity was measured by VAS from 0 to 10'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'The study is a prospective, randomized controlled, double-blind study. The enrolled patients were randomly divided into two groups: the intraarticular glucose group and the intraarticular HA group.', 'detailedDescription': 'The glucose group underwent 3 sessions of 6cc 25% glucose injection with a 2-week interval between each treatment. The HA group was administered intra-articular HA ((Hyruan PlusR, average MW 3000 kD; LG Life Sciences Ltd, Korea)) for sessions with a 1-week interval between each treatment. The results were measured with the visual analogue scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Lequesne index. A baseline for each test was measured before treatment and then the effects of the treatments were measured by each test at 6 and 12 weeks after treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. people aged 45 years or more;\n2. subjects diagnosed with knee OA according to the clinical criteria of the American College of Rheumatology\n3. subjects diagnosed with grade II or III OA during radiological examination as defined by the radiological classification of Kellgren and Lawrence (K-L) scale for knee OA\n4. subjects with tenderness in the medial tibial plateau area\n\nExclusion Criteria:\n\n1. . subjects having other illnesses of neurologic diseases, cardiac disorders, hemodynamically unstable systems, or physical functions;\n2. . Inflammatory arthritis or subjects with acute knee arthritis\n3. . subjects who have received intraarticular injection on the affected knee within the past 3 months.\n4. . subjects with previous medical histories involving the affected knee such as surgeries, cancer and maligament tumors.'}, 'identificationModule': {'nctId': 'NCT03690232', 'briefTitle': 'Intraarticular Glucose Versus Hyaluronic Acid Injection for Knee Osteoarthrosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'Comparison of the Clinical Efficacy of Intraarticular Glucose Versus Hyaluronic Acid Injection for Knee Osteoarthrosis', 'orgStudyIdInfo': {'id': '2018-01-014C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glucose group', 'description': 'The glucose group underwent 3 sessions of 6cc 25% glucose injection with a 2-week interval between each treatment', 'interventionNames': ['Drug: glucose water']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'hyaluronic acid group', 'description': 'The HA group was administered intra-articular HA ((Hyruan Plus® , average MW 3000 kD; LG Life Sciences Ltd, Korea)) for sessions with a 1-week interval between each treatment.', 'interventionNames': ['Drug: hyaluronic aicd']}], 'interventions': [{'name': 'glucose water', 'type': 'DRUG', 'description': '3 sessions of 6cc 25% glucose injection with a 2-week interval', 'armGroupLabels': ['Glucose group']}, {'name': 'hyaluronic aicd', 'type': 'DRUG', 'otherNames': ['Hyruan'], 'description': 'intra-articular HA ((Hyruan Plus® , average MW 3000 kD; LG Life Sciences Ltd, Korea)) for sessions with a 1-week interval between each treatment', 'armGroupLabels': ['hyaluronic acid group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '241', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Jia chi c Wang, MD', 'role': 'CONTACT', 'email': 'jcwang0726@gmail.com', 'phone': '886-2-28757361'}], 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Jia chi Wang, MD', 'role': 'CONTACT', 'email': 'jcwang0726@gmail.com', 'phone': '886-2-28757361'}], 'overallOfficials': [{'name': 'Jia chi Wang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taipei Veterans General Hospital, Taiwan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}