Effect of green lipped mussel powder on joint health; a randomized, double-blinded, placebo-controlled clinical trial
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0008821
- Lead Sponsor
- Pusan National University Korean Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 100
1. Adult men and women between the ages of 40 and 75
2. Those with a knee joint pain score (Visual Analogue Scale (VAS)) of 3/10 or higher
3. Those who are grade 1 or 2 on the Kellgren & Lawrence grading scale through ‘Both Knee Joint AP/LAT’
4. Those who have had a wash-out period of arthritis-related medicines or health functional foods for more than 4 weeks
5. Applicants who are capable of normal physical activity are subjects of this test and voluntarily agree in writing to the test consent form
1. Those with a history of fracture within the last year
2. Those who are diagnosed with moderate arthritis and are accompanied by osteophytes around the joints, irregular joint surfaces, and subchondral bone cysts of the joints.
3. Those diagnosed with thyroid disease and currently receiving treatment
4. Those with kidney disease or serum creatinine level of 1.4 mg/dL or higher
5. Those with proteinuria of 2+ or more
6. Those with liver disease (excluding fatty liver) or AST or ALT of 100 IU/L or more
7. Patients with uncontrolled high blood pressure or heart diseases such as angina pectoris or myocardial infarction
8. Persons taking medication for psychiatric illness (excluding cases of intermittent medication due to sleep disorders)
9. Those who have taken any herbal medicine or herbal medicine within 2 months before the screening test
10. Those who received other investigational drugs within 4 weeks before the screening test
11. Persons who must continue to take drugs that are judged to have an effect on the results of human application tests
12. Those with a history of gastrointestinal resection (excluding the appendix)
13. Pregnant or lactating women
14. Alcohol abuse
15. Persons with hypersensitivity to the test food or its ingredients
16. Persons who may be uncooperative in this examination
Or a person who the researcher determines is unable to proceed with the test.
17. A person who, at the discretion of the test director, has arthritis caused by a specific factor other than degenerative disease.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method WOMAC questionnaire total score
- Secondary Outcome Measures
Name Time Method WOMAC questionnaire detailed item scores (pain, joint stiffness, physical function);Visual Analogue Scale;ESR(Erythrocyte Sedimentation Rate);CRP(C-reactive protein) density