NCT05764304

Sinomenine Versus Glucocorticoid for Knee OA

Therapeutic Evaluation of Treatment With Sinomenine Versus Glucocorticoid for Early Knee Osteoarthritis: A Prospective, Double-Blind, Randomized, Multicenter Clinical Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 328 (estimated)
• Sponsor: Shanghai 6th People's Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	Sinomenine	Participants will receive one intra-articular injection every 4 months
DRUG	Glucocorticoid	Participants will receive one intra-articular injection every 4 months

Timeline

• Start date: 2023-02-28
• Primary completion: 2025-02-27
• Completion: 2025-03-31
• First posted: 2023-03-10
• Last updated: 2023-03-10