Placebo-controlled, randomized double-blind study to evaluate the efficacy and tolerability of Rosaxan® in patients with Gonarthrosis
- Conditions
- M17Gonarthrosis [arthrosis of knee]
- Registration Number
- DRKS00009034
- Lead Sponsor
- medAgil Gesundheitsgesellschaft mbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 92
• clinically diagnosed Gonarthrosis one or both knees with: o moderate pain symptoms [4-8 points as the average of the WOMAC pain index]
• neg. Pregnancy test (ß HCG) prior inclusion of child-bearing women
• contraceptive protection for child-bearing women
Knee pain or functional limitation of the knee joint other cause • Threat of disability • Known allergies and / or sensitivities to components of the investigational product • Major organic and / or systemic diseases that are unacceptable to continue the participation from investigator view • ingestion (during the study) of: • dietary supplements such as vitamin supplements
• Complementary balanced diets • anti-inflammatory plant extracts like e.g. Devil's Claw • enzyme preparations such as Wobenzym® • mineral products, protein hydrolysates, Amino acid concentrates • chondroprotectives (cartilage protection products as e.g. Glucosamine, chondroitin sulfate, collagen Hydrolyzate, gelatin, hyaluronic acid, Methylsulfonylmethane)
• Fish oil capsules (omega 3 fatty acid capsules) • treatment with cartilage protection products in the last 3 Months and during the study • treatment during the study (oral ingestion, injection, topical application) with steroidal and non- Antirheumatic drugs with the exception of: Acetylsalicylic acid (ASA, aspirin), diclofenac (Voltaren example) and Paracetamol
• Cortisone treatment in the last 3 weeks and during the study
• Administration of opioid analgesics, • pregnancy or lactation • medication, alcohol and / or drug abuse • peripheral arterial occlusive disease (PAOD) • acute meniscus injuries Rheumatoid arthritis • infection-associated arthritis • Bony injuries of the lower extremities (eg Femoral neck fracture) in the last 12 months • herniated disc • Arthroscopic surgery of the knee joint in the last 6 months and during the study
•Concomitant treatment of osteoarthritis of the knee with Magnetic therapy, shockwave therapy, acupuncture during study
• Signs that the patient is unable to comply with the protocol (eg, lack of cooperation) • Simultaneous participation in another clinical trial or participation in such within the last 6 weeks • Dependence / working relationship with the sponsor or investigator
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome: <br>Change in the WOMAC index Pain as the difference between the score values ??at baseline and the final visit after 12 weeks compared to the study groups (verum or placebo)
- Secondary Outcome Measures
Name Time Method Secondary outcomes measures: <br>Differences between verum and Placebo group:<br>• changes in the WOMAC index pain after 6 weeks • changes in the WOMAC global index after 6 and 12 weeks <br>• changes in the WOMAC indices function and stiffness after 6 and 12 weeks<br>• Changes in quality of life (SF-12) after 6 and 12 weeks<br>• change in analgesics consumption during the study period<br>• adverse events occurrence (UE) during the study period<br>• Global evaluation of efficacy and tolerability by investigator and patient after 12 weeks