Antarctic Krill Oil for Knee Osteoarthritis Pain

Exclusion Criteria

• •Ipsilateral hip osteoarthritis;
• •Diagnosis of rheumatoid arthritis (RA), ankylosing spondylitis, sarcoidosis, amyloidosis, or any other inflammatory arthritis (e.g., gout, pseudogout);
• •Chronic pain syndromes, fibromyalgia, or comorbidities that may confound knee pain assessment;
• •Pain intensity in the lower extremities or back equal to or greater than knee pain;
• •Arthroscopic or open knee surgery within the preceding 12 months or planned during the study period;
• •Oral, intra-articular, or intramuscular corticosteroid use within 6 months prior to screening or during the study;
• •Intra-articular hyaluronic acid injection within 6 months prior to screening or during the study;
• •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);
• •Bleeding disorders or anticoagulant use within 1 month (except low-dose aspirin ≤150 mg/day);
• •Regular use of glucosamine, fish oil, or other supplements unless a ≥4-week washout period (≥3 months for fish oil) is completed prior to Day 1;
• •Hypersensitivity to trial medications or seafood;
• •Administration of any medication within 6 months prior to Day 1 that may interfere with study outcomes, as judged by investigators;
• •Pregnancy (positive urine test at screening or Day 1), lactation, or inadequate contraception;
• •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;
• •Uncontrolled hypertension (screening blood pressure ≥140/90 mmHg) unless confirmed as non-hypertensive or well-controlled by a specialist;
• •Inability to provide informed consent.