Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-25 @ 7:08 PM
Study NCT ID:
NCT05764304
Status:
UNKNOWN
Last Update Posted:
2023-03-10
First Post:
2023-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sinomenine Versus Glucocorticoid for Knee OA
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C009271', 'term': 'sinomenine'}, {'id': 'D005938', 'term': 'Glucocorticoids'}], 'ancestors': [{'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 328}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-02-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-01', 'studyFirstSubmitDate': '2023-02-17', 'studyFirstSubmitQcDate': '2023-03-01', 'lastUpdatePostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Bone marrow lesion (BML)', 'timeFrame': '12 and 24 months after the first injection', 'description': '12 and 24 months after the first injection, to evaluate bone marrow lesion (BML) size of patients and whether sinomenine was noninferior to glucocorticoid.'}], 'primaryOutcomes': [{'measure': 'total WOMAC score and tibial cartilage volume', 'timeFrame': '24 months after the first injection', 'description': '24 months after the first injection (1) the change in the total WOMAC score from baseline and whether sinomenine was noninferior to glucocorticoid, and (2) the change in tibial cartilage volume from baseline (on average thickness in mm) and whether sinomenine was noninferior to glucocorticoid.'}], 'secondaryOutcomes': [{'measure': 'The Timed Up and Go and 20m walking time', 'timeFrame': '24 months after the first injection', 'description': '24 months after the first injection (1) the change in time from baseline in The Timed Up and Go (TUG) test and whether sinomenine was noninferior to glucocorticoid, and (2) the change in time spent at 20m walking time from baseline was and whether sinomenine was noninferior to glucocorticoid.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Both glucocorticoid and sinomenine are widely used in the routine clinical treatment of osteoarthritis, but there is still a lack of high level of clinical evidence for the direct comparison of efficacy between the two drugs. This trial aims to evaluate whether intraarticular injection of sinomenine was noninferior to intraarticular injection of glucocorticoid for symptom relief in patients with early knee arthritis, and whether intraarticular injection of sinomenine was superior to intraarticular injection of glucocorticoid for changes in tibial cartilage volume (measured by mean thickness) from baseline compared with intraarticular injection of glucocorticoid. 326 people will participate in the study at 3 different research/medical institutions, with centres competing for inclusion. This trial was designed by random blind method. This trial will last for 2 years and participants will receive 6 injections every 4 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\> 40 and \\<70.\n2. Bilateral knee pain lasting for more than 6 months and most of the last month;\n3. X-rays showed that Kellgren and Lawrence had grade 2 or 3 knee osteoarthritis.\n\nExclusion Criteria:\n\n1. Kellgren and Lawrence Level 1 or 4.\n2. Radiographs showed that the reduction of the lateral joint space was greater than or equal to the medial joint space.\n3. The affected knee had been injected with glucocorticoid or hyaluronic acid within the past 6 months.\n4. Have had knee surgery or plan to have joint surgery on the affected knee.\n5. Other medical conditions such as: systemic or inflammatory joint diseases (rheumatoid arthritis), history of crystalline or neurological joints, other muscular, joint or nervous system diseases affecting lower limb function.\n6. Have a needle phobia.\n7. Immunosuppression or acute infection is present.\n8. Patients are allergic to the drugs involved in the study.\n9. Have or have had cancer or tumours.\n10. Have a hemorrhagic disease or are receiving anticoagulant or antiplatelet therapy.\n11. History of hyperlipidemia, or plasma total cholesterol ≥6.2mmol/L and triglycerides \\>2.3mmol/L\n12. Have any other medical conditions that do not participate in the study, including contraindications to MRI, such as pacemakers.\n13. Pregnancy.\n14. Body mass Index (BMI) \\> 40 kg/m2.\n15. Unable to attend all study appointments within 24 months;\n16. Inability to understand written and spoken Chinese.\n17. Any history of mental and psychological illness.'}, 'identificationModule': {'nctId': 'NCT05764304', 'briefTitle': 'Sinomenine Versus Glucocorticoid for Knee OA', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 6th People's Hospital"}, 'officialTitle': 'Therapeutic Evaluation of Treatment With Sinomenine Versus Glucocorticoid for Early Knee Osteoarthritis: A Prospective, Double-Blind, Randomized, Multicenter Clinical Trial', 'orgStudyIdInfo': {'id': '2021-277'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sinomenine', 'interventionNames': ['Drug: Sinomenine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glucocorticoid', 'interventionNames': ['Drug: Glucocorticoid']}], 'interventions': [{'name': 'Sinomenine', 'type': 'DRUG', 'description': 'Participants will receive one intra-articular injection every 4 months', 'armGroupLabels': ['Sinomenine']}, {'name': 'Glucocorticoid', 'type': 'DRUG', 'description': 'Participants will receive one intra-articular injection every 4 months', 'armGroupLabels': ['Glucocorticoid']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 6th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Changqing Zhang', 'investigatorAffiliation': "Shanghai 6th People's Hospital"}}}}