Knee Pain Ejiao Paste for Knee Osteoarthritis

Sponsor
ShuGuang Hospital
Study ID
NCT07504562
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Knee Pain Ejiao Paste — DRUG
    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.
  • Knee Pain Ejiao-free Clear Paste — DRUG
    Using an Ejiao-free clear paste as a parallel control.

Study Details

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.

Key Dates

First listed
Apr 1, 2026
Start date
Mar 30, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Knee Pain Ejiao Paste
    Knee Pain Ejiao Paste: Oral administration, 1 bag per dose, twice daily (20g per dose); Composition: Xi Yang Shen (Panacis Quinquefolii Radix, 260g), Long Yan Rou (Arillus Longan, 1300g), Shan Yao (Dioscoreae Rhizoma, 1300g), and E Jiao (Colla Corii Asini, 350g); Instruction: It is recommended to take the medication at a fixed time each day.
  • Placebo Comparator: Knee Pain Ejiao-free Clear Paste
    Knee Pain Ejiao-free Clear Paste: Oral administration, 1 bag per dose, twice daily (20g per dose); Composition: Xi Yang Shen (Panacis Quinquefolii Radix, 260g), Long Yan Rou (Arillus Longan, 1300g), Shan Yao (Dioscoreae Rhizoma, 1300g), and Mu Tang Chun (Xylitol, 350g)

Primary Outcome Measure

Change from baseline in Numerical Rating Scale (NRS) score for target knee pain at Week 12 [ Time Frame: Screening Period/Baseline, Week 12 ]

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