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NCT05764304

Sinomenine Versus Glucocorticoid for Knee OA

Status unknown Phase 3 Last updated 10 March 2023
What this trial tests

Phase 3 trial testing Sinomenine in Knee Osteoarthritis in 328 participants. Status unknown.

Timeline
28 February 2023
Primary endpoint
27 February 2025
31 March 2025

Quick facts

Lead sponsorShanghai 6th People's Hospital
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment328
Start date28 February 2023
Primary completion27 February 2025
Estimated completion31 March 2025

Drugs / interventions tested

Conditions studied

Sponsor

Shanghai 6th People's Hospital

Who can join

Adults 40 to 70, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Redox regulation: mechanisms, biology and therapeutic targets in diseases.
    Li B, Ming H, Qin S, Nice EC, et al · · 2025 · cited 104× · PMID 40050273 · DOI 10.1038/s41392-024-02095-6
  2. Cartilage organoids bridging bench to bedside: A steroid-free strategy for early osteoarthritis repair.
    Zhang X, Lin Z, Lv M, Lu C, et al · · 2026 · PMID 41560786 · DOI 10.1016/j.mtbio.2025.102688

Verify or expand the search:

Other recruiting trials for Knee Osteoarthritis

Currently open trials in the same condition.

Other Shanghai 6th People's Hospital trials

Trials by the same sponsor.

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