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Knee Pain Ejiao Paste in Knee Osteoarthritis
NCT07504562Phase 2
Key facts
- Status
- Enrolling by invitation
- Start
- Mar 2026
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- Shuguang Hospital
- Modality
- TCM (Traditional Chinese Medicine)
- Conditions
- knee osteoarthritis (OA)
01
Overview
Phase 2, randomised, double-blind trial of Knee Pain Ejiao Paste in knee osteoarthritis (OA) (2 arms), sponsored by Shuguang Hospital. Primary endpoint: Numerical Rating Scale score for target knee pain at 12 weeks. Started Mar 2026; status: enrolling by invitation.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Knee Pain Ejiao Paste
Oral administration, 1 bag per dose, twice daily (20g per dose)
Knee Pain Ejiao-free Clear Paste
Oral administration, 1 bag per dose, twice daily (20g per dose)
03
Who it enrols
Patients aged 40-75 with knee osteoarthritis and Qi and Blood Deficiency Pattern, with an NRS pain score >= 4, excluding those with other confounding joint diseases or recent use of specific OA treatments.
04
Endpoints
Primary
Numerical Rating Scale score for target knee pain
Secondary
Patient Electronic Diary Joint Pain NRS Score
Numerical Rating Scale score for target knee pain
Pain relief rate of target knee pain
Time to onset of target knee pain relief
Western Ontario and McMaster Universities Osteoarthritis Index total score
WOMAC subscale scores (Pain, Stiffness, and Physical Function)
MRI Osteoarthritis Knee Score for joint effusion
Subject satisfaction scores
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