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.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing an Ejiao paste for knee osteoarthritis pain — can you explain what Ejiao is and whether there's any existing safety or effectiveness data I should know about before considering it?
2Since this is a Phase 2 trial, what does that mean for what's already known — and what's still uncertain — about how safe and effective this paste might be compared to treatments I could start right now?
3The trial is 'enrolling by invitation only' — do you know how patients are selected, and is this something you could refer me for if you thought it was appropriate for my situation?
4The main thing being measured is how much my knee pain score changes over 12 weeks — given where my pain level is right now, do you think that timeframe and that type of outcome measurement makes sense for my particular case?
5Before discussing a trial like this, do you think I should try standard treatments for knee osteoarthritis first, or is my situation one where exploring an experimental option like this could be a reasonable path?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in Numerical Rating Scale (NRS) score for target knee pain at Week 12
. 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