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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sinomenine | Experimental |
| |
| Glucocorticoid | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sinomenine | Drug | Participants will receive one intra-articular injection every 4 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| total WOMAC score and tibial cartilage volume | 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. | 24 months after the first injection |
| Measure | Description | Time Frame |
|---|---|---|
| The Timed Up and Go and 20m walking time | 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. | 24 months after the first injection |
| Measure | Description | Time Frame |
|---|---|---|
| Bone marrow lesion (BML) | 12 and 24 months after the first injection, to evaluate bone marrow lesion (BML) size of patients and whether sinomenine was noninferior to glucocorticoid. | 12 and 24 months after the first injection |
Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41560786 | Derived | Zhang X, Lin Z, Lv M, Lu C, Hu B, Yu W, Wang Z, Liu X, Zhang C, Wu D, He Y. Cartilage organoids bridging bench to bedside: A steroid-free strategy for early osteoarthritis repair. Mater Today Bio. 2025 Dec 21;36:102688. doi: 10.1016/j.mtbio.2025.102688. eCollection 2026 Feb. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C009271 | sinomenine |
| D005938 | Glucocorticoids |
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
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| Glucocorticoid |
| Drug |
Participants will receive one intra-articular injection every 4 months |
|
| D012216 |
| Rheumatic Diseases |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |