DRKS00009034
Completed
未知
Placebo-controlled, randomized double-blind study to evaluate the efficacy and tolerability of Rosaxan® in patients with Gonarthrosis - MEA/008915
medAgil Gesundheitsgesellschaft mbH0 sites92 target enrollmentJanuary 25, 2016
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- M17
- Sponsor
- medAgil Gesundheitsgesellschaft mbH
- Enrollment
- 92
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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