Investigation of the effects of cartilage structure nutrients on symptoms of knee osteoarthritis: a 12-weeks, randomized, double-blind, placebo-controlled pilot study
- Conditions
- M17Gonarthrosis [arthrosis of knee]
- Registration Number
- DRKS00029563
- Lead Sponsor
- Apomedica Pharmazeutische Produkte GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 54
Main inclusion criteria:
• Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
• Sex: female and male (minimum 25% of each gender)
• Subjects with primary osteoarthritis who are not expected to require surgical treatment for at least three months after inclusion.
• Known X-ray or MRI finding (Kellgren score of 1 to 3; X-ray or MRI not older than 36 months)
• Discomfort over a period of at least 3 months
• KOOS pain score with maximum 75 (Maximum 100 (no pain problems)) at screening
• Age: 40 – 75 years
• BMI: 19 – 32 kg/m2
• Subjects agree to maintain physical activity levels throughout the study
• Except for osteoarthritis, the subject is in good physical and mental health as established by medical history, physical examination, vital signs, results of biochemistry, hematology
Main exclusion criteria
• Inflammatory, infectious or metabolic joint disorder
• Artificial joint replacement in knees or hip
• Surgery within the last 6 months in knees or hip
• Intra-articular therapy within the last 3 months
• Oral cartilage treatment within the last 3 months including also supplements e.g. glucosamine, chondroitin, hyaluronic acid or collagen.
• Medical treatment of joint disease besides Paracetamol as analgesic medication for emergency treatment
• Relevant history or presence of any severe medical disorder, potentially interfering with this study (e.g. mal absorption, chronic gastro-intestinal diseases (e.g. Morbus Crohn, Colitis Ulcerosa), heavy depression, significant cardiovascular disease or co-morbidities (e.g. myocardial infarction, stroke, congestive heart failure), diabetes, acute malignant disease within last 3 years except basal cell carcinoma of the skin, etc.)
• Present or recent use of drugs and dietary supplements with anti-inflammatory properties that could interfere with the study 2 months before or during the study (e.g. Curcumin, omega-3 FA, chronic intake of NSAR, ibuprofen, glucocorticoids (except inhalative) etc.), antioxidative supplements (e.g. vitamin C, vitamin E) or further antioxidative supplements (e.g. OPC etc.).
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Parameter will be evaluated exploratory. Therefore main parameter are listed in this section: <br>- Change in Knee injury and Osteoarthritis Outcome Score (KOOS) with its subdomains measured at baseline, after 6 and 12 weeks <br>- Change in performance based tests (40 m fast paced walk test, chair stand repetitions, stair claimbing) measured at baseline and after 6 and 12 weeks<br>- Global assessment
- Secondary Outcome Measures
Name Time Method - SF-36 questionnaire at baseline and after 12 weeks<br>- Biomarker cartilage oligomeric matrix protein (COMP) at baseline and after 12 weeks