M17
Conditions
Interventions
Group 1: Multinutrient food supplement with Glucosaminhydrochlorid, Chondroitinsulfate, Collagen complex with Type II collagen, mucopolysaccharids, hyaluronic acid, methylsulfonylmethan (MSM), seleniu
Sponsors
Apomedica Pharmazeutische Produkte GmbH
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parameter will be evaluated exploratory. Therefore main parameter are listed in this section: - Change in Knee injury and Osteoarthritis Outcome Score (KOOS) with its subdomains measured at baseline, after 6 and 12 weeks - 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 - Global assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| - SF-36 questionnaire at baseline and after 12 weeks - Biomarker cartilage oligomeric matrix protein (COMP) at baseline and after 12 weeks | — |
Countries
Germany
Outcome results
None listed