None listed
Conditions
Interventions
Dietary Supplement : This clinical trial is a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the effects of oral intake of oyster hydrolysate on joint and cart
Sponsors
Dong-eui University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female adults aged between 40 and 75 years 2. Individuals with knee joint pain scoring 30 to 100 mm on the Visual Analogue Scale (VAS) 3. Individuals whose bilateral knee joint X-rays (AP/LAT views) are classified as Grade 1 or 2 according to the Kellgren & Lawrence grading scale 4. Individuals capable of performing normal physical activity and who voluntarily agree to participate by signing the written informed consent form after receiving a full explanation of the study
Exclusion criteria
Exclusion criteria: 1. Individuals with a body mass index (BMI) greater than 29 kg/m² 2. History of bone fracture within the past 1 year 3. Presence of meniscal tear 4. Individuals with osteophytes around the joint, irregular joint surfaces, or subchondral cysts, and judged to have moderate osteoarthritis 5. Use within 4 weeks prior to screening of COX-2 inhibitors, NSAIDs, or dietary supplements affecting joint function (e.g., glucosamine, green-lipped mussel oil complex, Boswellia extract, chondroitin, MSM, vitamin D, collagen, turmeric extract, or Taheebo extract), or those who are required to take such supplements during the study 6. Individuals diagnosed with thyroid disease and currently undergoing treatment 7. Individuals with renal disease or serum creatinine = 1.4 mg/dL 8. Individuals with liver disease or AST or ALT = 100 IU/L 9. Individuals with uncontrolled hypertension (=160/100 mmHg), angina, myocardial infarction, or other significant cardiovascular diseases 10. Individuals taking medication for psychiatric disorders (except intermittent use for sleep disorders) 11. History of taking herbal medicine or traditional remedies within the past 2 months 12. Participation in another clinical trial or use of investigational drugs within the past 4 weeks 13. Individuals who must continue using medications that may interfere with study outcomes 14. History of gastrointestinal surgery (excluding appendectomy) 15. Pregnant or lactating women 16. Individuals with alcoholism or those who consume alcohol more than 4 times per week on a regular basis 17. Individuals with a history of allergy or hypersensitivity to components of the test food (e.g., oysters, fish, shellfish, etc.) 18. Individuals who are likely to be non-compliant with the study protocol or deemed unsuitable for participation by the investigator 19. Individuals judged by the investigator to have arthritis caused by non-degenerative factors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the total score of the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in WOMAC subscale scores (pain, stiffness, and physical function);Change in VAS (Visual Analogue Scale) score;Change in the concentrations of pro-inflammatory cytokines (TNF-a, IL-1ß, IL-6);Change in serum Cartilage Oligomeric Matrix Protein concentration;Change in the concentrations of anti-inflammatory markers (C-reactive protein, erythrocyte sedimentation rate) | — |
Countries
Korea, Republic of
Contacts
Public ContactBong Jin Shin
Pusan National University Korean Medicine Hospital
Outcome results
None listed