Status:
NOT_YET_RECRUITING
Antarctic Krill Oil for Knee Osteoarthritis Pain
Lead Sponsor:
Qilu Hospital of Shandong University
Conditions:
Osteoarthritis (OA) of the Knee
Osteoarthritis Knee Pain
Eligibility:
All Genders
45-75 years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to evaluate the effectiveness and safety of Antarctic Krill Oil (AKO) as a dietary supplement in managing pain associated with knee osteoarthritis (OA). The main que...
Detailed Description
Osteoarthritis (OA) is a chronic degenerative disease affecting the entire joint apparatus, characterized by pathological alterations in articular cartilage, subchondral bone, synovium, and joint caps...
Eligibility Criteria
Inclusion
- Aged 45-75 years；
- 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；
- Knee pain Visual Analog Scale (VAS) score between 4.0 and 8.0；
- Ability to comprehend and complete VAS and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) assessments；
- Willingness and ability to undergo knee MRI examinations.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT06880926
Start Date
April 1 2025
End Date
February 28 2026
Last Update
March 18 2025
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