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NOT YET RECRUITING

NCT06880926

PHASE2

Antarctic Krill Oil for Knee Osteoarthritis Pain

Sponsor: Qilu Hospital of Shandong University

View on ClinicalTrials.gov

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 questions it aims to answer are: ①Does AKO reduce daily pain intensity in participants with moderate knee OA? ②What adverse effects do participants experience when taking AKO? Researchers will conduct a randomized, double-blind study comparing AKO to a placebo (identical appearance without active components) to assess: * Changes in joint pain severity; ②Functional improvement in daily activities; ③Biochemical safety parameters,etc.

Official title: A Randomized, Double-Blind, Parallel-Controlled, Multicenter Clinical Trial of Antarctic Krill Oil in the Management of Knee Osteoarthritis Pain

Key Details

Gender

All

Age Range

45 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

116

Start Date

2025-04-01

Completion Date

2026-02-28

Last Updated

2025-03-18

Healthy Volunteers

Conditions

Osteoarthritis (OA) of the Knee Osteoarthritis Knee Pain

Interventions

DRUG

Krill oil

Antarctic krill oil was used for intervention in the experimental group.

DIETARY_SUPPLEMENT

Olive Oil

Olive oil was used for intervention in the placebo group.

Inclusion Criteria: * 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 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.