NCT07504562

Knee Pain Ejiao Paste for Knee Osteoarthritis

A Randomized, Double-Blind, Two-Control Clinical Study of Knee Pain Ejiao Paste in the Treatment of Knee Osteoarthritis (Qi and Blood Deficiency Pattern)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: ShuGuang Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To explore the analgesic efficacy of Knee Pain Ejiao Paste in the treatment of knee osteoarthritis (Qi and Blood Deficiency Pattern) after 12 weeks, using an Ejiao-free clear paste as a parallel control and incorporating a synthetic external control.

Detailed description

Overall Design: This study employs a randomized, double-blind, internal and external dual-control clinical trial design. Trial Procedures: The trial consists of a screening/baseline period and a 12-week treatment period, with an End-of-Study (EOS) or End-of-Treatment (EOT) visit conducted after 12 weeks of administration. Randomization and Blinding: A stratified block randomization method will be used to assign participants to each group in a 1:1 ratio, with competitive enrollment across all centers and a double-blind design. External Control: Literature-based data. Data Collection: Electronic Data Capture (EDC) system and Electronic Patient-Reported Outcome (ePRO) system.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	Knee Pain Ejiao Paste	By comparing Knee Pain Ejiao Paste with the base formula, Knee Pain Ejiao-free Clear Paste, this study minimizes confounding factors such as dosage form, administration method, and matrix components. This approach allows for a precise evaluation of the incremental therapeutic benefits contributed by the addition of Ejiao, thereby providing direct evidence for the medicinal value of Colla Corii Asini.
DRUG	Knee Pain Ejiao-free Clear Paste	Using an Ejiao-free clear paste as a parallel control.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-03-31
• Completion: 2028-12-31
• First posted: 2026-04-01
• Last updated: 2026-04-01

Locations

2 sites across 1 country: China