Knee joint pain, joint stiffness, pain during squatting or stair climbing, restricted ambulation, and joint swelling.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 35–56 years (including 20 participants aged 35–45 and 20 participants aged 46–56). 2. BMI 18~30 kg/m^2; 3. Able to understand and sign the written informed consent form. 4. No serious systemic diseases that would interfere with the assessments. 5. Has not participated in, and will not concurrently participate in, any other studies involving related content within the past month. 6. In accordance with the diagnostic criteria for osteoarthritis outlined in the Chinese Osteoarthritis Diagnosis and Treatment Guidelines (2024 edition), participants were required to meet criterion 1 plus any two of the following criteria: Recurrent knee pain within the past month; Age >=50 years; Morning stiffness lasting <=30 minutes; Presence of crepitus (palpable or audible) during knee joint movement; Radiographic evidence (standing or weight-bearing X-ray) of joint space narrowing in the knee, with or without subchondral sclerosis, cystic changes, or marginal osteophyte formation.
Exclusion criteria
Exclusion criteria: 1. Currently receiving or having recently used potent anti-inflammatory or immunosuppressive medications (e.g., long-term high-dose triamcinolone, cyclosporine, etc.); short-term, as-needed antipyretic/analgesic use (e.g., paracetamol) may be documented but must remain stable. 2. Planning to undergo surgery or intra-articular injections (e.g., hyaluronic acid or corticosteroid injections) in the same joint. 3. Known history of severe allergy to fish/seafood or to excipients contained in the investigational product. 4. Severe hepatic or renal insufficiency, active malignancy, or women who are pregnant or breastfeeding. 5. Participants enrolled in other interventional clinical studies. 6. Conditions or ethical considerations that, in the investigator’s judgment, make the individual unsuitable for participation (e.g., individuals with hyperuricemia). 7. Use of products related to the study outcomes within the past 3 months that may affect result interpretation, such as health supplements (e.g., glucosamine, chondroitin sulfate, hyaluronic acid, curcumin, omega-3, collagen) or therapeutic agents including anti-inflammatory analgesics and corticosteroids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total and subscale scores (pain, stiffness, function) of the WOMAC from Day 0 to Week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in VAS (resting/walking) pain scores (0–10) from Day 0 to Week 12. (Primarily assessed using patient-reported VAS);Change in knee joint X-ray Kellgren–Lawrence (K-L) grading from baseline to Week 12, used to evaluate trends in structural improvement; | — |
Countries
China
Contacts
Shanghai Fengxian District Central Hospital