Knee Osteoarthritis: Patients diagnosed with knee osteoarthritis according to the Chinese Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 edition) issued by the Chinese Medical Association, with Kellgren-Lawrence grade 1-3 and knee pain Visual Analog Scale (VAS) scores ranging from 4.0 to 8.0.
Conditions
Interventions
Placebo group:Oral administration of olive oil
Experimental group:Oral administration of Antarctic krill oil
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 45–75 years; 2. Clinically diagnosed with knee osteoarthritis per the Chinese Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 edition) issued by the Chinese Medical Association, with Kellgren-Lawrence grade 1–3; 3. Knee pain Visual Analog Scale (VAS) score between 4.0 and 8.0; 4. Ability to comprehend and complete VAS and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) assessments; 5. Willingness and ability to undergo knee MRI examinations.
Exclusion criteria
Exclusion criteria: 1. Ipsilateral hip osteoarthritis; 2. Diagnosis of rheumatoid arthritis (RA), ankylosing spondylitis, sarcoidosis, amyloidosis, or any other inflammatory arthritis (e.g., gout, pseudogout); 3. Chronic pain syndromes, fibromyalgia, or comorbidities that may confound knee pain assessment; 4. Pain intensity in the lower extremities or back equal to or greater than knee pain; 5. Arthroscopic or open knee surgery within the preceding 12 months or planned during the study period; 6. Oral, intra-articular, or intramuscular corticosteroid use within 6 months prior to screening or during the study; 7. Intra-articular hyaluronic acid injection within 6 months prior to screening or during the study; 8. High-dose NSAID use (>= maximum recommended daily dose for osteoarthritis pain relief) within 1 month prior to screening, including but not limited to: Diclofenac >=150 mg/day; Aceclofenac >=100 mg/day; Meloxicam >=15 mg/day; Naproxen >=1,000 mg/day; Piroxicam >=20 mg/day; Ibuprofen >2,400 mg/day (Exempt if a >=4-week washout period is completed prior to Day 1); 9. Bleeding disorders or anticoagulant use within 1 month (except low-dose aspirin =4-week washout period (>=3 months for fish oil) is completed prior to Day 1; 11. Hypersensitivity to trial medications or seafood; 12. Administration of any medication within 6 months prior to Day 1 that may interfere with study outcomes, as judged by investigators; 13. Pregnancy (positive urine test at screening or Day 1), lactation, or inadequate contraception; 14. History of alcoholism, substance abuse, major systemic diseases (e.g., renal, cardiac, hepatic, or gastrointestinal disorders), or conditions deemed by investigators to compromise study participation or data integrity; 15. Uncontrolled hypertension (screening blood pressure >=140/90 mmHg) unless confirmed as non-hypertensive or well-controlled by a specialist; 16. Inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Reactions;Visual Analogue Pain Scale;Serious Adverse Reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS Pain Score Change from Baseline;WOMAC Pain Subscale;WOMAC Stiffness Subscale;Volume of Joint Effusion;WOMAC Physical Function Subscale; | — |
Countries
China
Contacts
Public ContactYuankai Zhang
Qilu Hospital of Shandong University
Outcome results
None listed