drugset / Trial / NCT05764304

Sinomenine Versus Glucocorticoid for Knee OA

NCT05764304

Phase 3 Unknown 328 enrolled Shanghai 6th People's Hospital
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2023-02-28
Primary completion
2025-02-27
Completion
2025-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Sinomenine Small molecule Other
Comparator Triamcinolone Acetonide Other / unclassified Other

Indications