Effect of a dietary supplement purposes in patients with osteoarthritis - Randomized, placebo-controlled, double-blind intervention study
- Conditions
- M17.0Primary gonarthrosis, bilateral
- Registration Number
- DRKS00000724
- Lead Sponsor
- eibniz Universtiät HannoverInstitut für Lebensmittelwissenschaft und Humanernährung
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 212
Men and women >18 years - diagnosed gonarthrosis - WOMAC subscore pain >/=15 points, >/=150 mm, respectively
allergy or intolerance to any component of the test product - severe chronic diseases (tumors etc) - severe cardiovascular disease, renal failure, liver disease - chronic inflammatory joint diseases, infectious diseases of the joints - classification of Kellgren stage IV - BMI >40 kg/m² - chronic diseases of the gastrointestinal tract - taking additional glucosamine, chondroitin and hyaluronic acid-containing products before or during the study - intra-articular injections - intra-articular and systemic corticosteroid therapy - pain relief or ointments during the study - pregnancy and lactation - alcohol, drug addiction - incapacitated subjects - refusal or withdrawal of consent by the subjects - simultaneous participation in another clinical study or participation within the past 30 days
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method WOMAC Score (Questionnaire), Measurement of changes after 24 weeks compared to baseline
- Secondary Outcome Measures
Name Time Method generel health (questionnaire): at baseline and after 6, 12, 18 and 24 weeks - blood parameters (blood count, liver enzymes, glucose, HbA1c, blood lipids, hsCRP, vitamin C, vitamin D, selenium, glutathione peroxidase) (blood samples): at baseline and after 6, 12, 18 and 24 weeks- documentation of acute medication (questionnaire and diary): at baseline and after 6, 12, 18 and 24 weeks