Knee Pain Ejiao Paste for Knee Osteoarthritis

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

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

Secondary outcome measures (12)

• Patient Electronic Diary (ePRO) Joint Pain NRS Score [Time frame: Baseline to Week 12]
• Change from baseline in NRS score for target knee pain at Weeks 4 and 8 [Time frame: Screening Period/Baseline, Week 4, and Week 8]
• Pain relief rate of target knee pain at Weeks 4, 8, and 12 post-treatment [Time frame: Screening Period/Baseline, Week 4, Week 8, and Week 12]
• Time to onset of target knee pain relief [Time frame: Baseline to Week 12]
• Change from baseline in WOMAC total score for the target knee at Weeks 4, 8, and 12 post-treatment [Time frame: Screening Period/Baseline, Week 4, Week 8, and Week 12]
• Changes from baseline in WOMAC subscale scores (Pain, Stiffness, and Physical Function) for the target knee at Weeks 4, 8, and 12 post-treatment [Time frame: Screening Period/Baseline, Week 4, Week 8, and Week 12]
• Comparison of MOAKS scores for joint effusion in the target knee at Week 12 post-treatment [Time frame: Screening Period/Baseline, Week 12]
• Change from baseline in subject satisfaction scores at Week 12 post-treatment [Time frame: Screening Period/Baseline, Week 4, Week 8, and Week 12]
• Change from baseline in investigator satisfaction scores at Week 12 post-treatment [Time frame: Screening Period/Baseline, Week 4, Week 8, and Week 12]
• Consumption of rescue medication during the treatment period [Time frame: Baseline to Week 12]
• Effective rate of TCM syndrome at Weeks 4, 8, and 12 post-treatment [Time frame: Screening Period/Baseline, Week 4, Week 8, and Week 12]
• Changes from baseline in TCM syndrome total scores and individual symptom scores at Weeks 4, 8, and 12 post-treatment [Time frame: Screening Period/Baseline, Week 4, Week 8, and Week 12]

Eligibility criteria

Inclusion criteria

• Meets the diagnostic criteria for knee osteoarthritis (OA), with unilateral or bilateral knee involvement
• Prior to randomization, the NRS pain score of the target knee joint ≥4, and the NRS score of the contralateral knee joint is not higher than that of the target knee joint; among the 5 pain items on the WOMAC, at least 1 item scores ≥40 mm
• Body Mass Index (BMI) ≤32 kg/m²
• Meets the diagnostic criteria for Qi and Blood Deficiency Pattern
• Age between 40 and 75 years inclusive (40 years ≤ age ≤ 75 years), male or female
• The Kellgren-Lawrence grading of the target knee joint is grade I-III, and the Kellgren-Lawrence grading of the contralateral knee joint is not higher than that of the target knee joint (in cases of unilateral disease, the affected side is the target knee joint; in cases of bilateral disease, the target knee joint must satisfy the above criteria)
• Voluntarily participates in this clinical trial, provides informed consent, and signs the informed consent form

Exclusion criteria

• Other conditions exist that may confound the assessment of function and pain in the target knee joint, such as: systemic diseases that may involve the joints (e.g., gouty arthritis, rheumatoid arthritis, etc.), chronic inflammatory or connective tissue diseases, neurological disorders, Paget's disease involving the knee, localized pain resulting from radicular lumbar compression, and any other conditions that may interfere with the efficacy assessment
• Use of other Chinese or Western medicines or therapies for osteoarthritis within one week prior to screening (excluding celecoxib tablets): such as non-steroidal anti-inflammatory drugs (excluding aspirin at no more than 325mg daily for cardiovascular disease prevention) , analgesics (including opioids, non-steroidal anti-inflammatory drugs, cyclooxygenase-2 (COX-2) inhibitors, tramadol, ketamine, clonidine, gabapentin, pregabalin and/or cannabinoids), or traditional Chinese medicine formulations with similar therapeutic indications to Knee Pain Ejiao Paste (i.e., those possessing qi-tonifying and blood-nourishing effects)
• Use within 4 weeks prior to screening of drugs that relieve osteoarthritis (OA) symptoms (such as glucosamine, chondroitin sulfate, diacerein, etc.), any nutritional supplements with potential activity on articular cartilage, systemic corticosteroids or immunosuppressive drugs (subjects requiring only inhaled corticosteroids for asthma treatment may be enrolled)
• Receipt of biological products or intra-articular drug injection therapy (e.g., glucocorticoids, sodium hyaluronate, medical chitosan, growth factors, platelet-rich plasma, stem cell therapy, etc.) within 3 months prior to screening
• Invasive procedures such as arthroscopy or lavage of the target knee joint within 6 months before screening or planned during the study period
• Previous or planned target knee joint replacement (partial or total), autologous osteochondral mosaicplasty, microfracture, meniscectomy, osteotomy or other surgery during the study period
• Planned change or new use of mobility aids (e.g., wheelchair, walker, cane or crutch) or need for lower limb prosthesis and/or structural knee brace during the study period
• Investigator-judged serious comorbid cardiovascular, cerebrovascular, gastrointestinal diseases, poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), or other conditions that could affect the assessment of the investigational product's efficacy and safety
• Laboratory abnormalities: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times the upper limit of normal (ULN), or creatinine (Cr) >ULN
• Known or suspected allergy to the investigational product, rescue medication, or any of their components
• Pregnant or lactating women, or women of childbearing potential planning pregnancy from enrollment through 3 months after the end of the study
• Known or suspected history of alcohol or drug abuse
• Intellectual disability, psychosis, or neurosis
• Subjects who participated in any interventional drug clinical trial and received the investigational drug within 3 months prior to enrollment, or who are within 5 half-lives (whichever is longer) of any other clinical trial drug

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 2 centers

• Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine — Shanghai
• Shanghai Municipal Hospital of Traditional Chinese Medicine — Shanghai

Identifiers

NCT: NCT07504562 · SG-XTEJG-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗