M17
Conditions
Interventions
Group 1: Verum: dietary supplements Rosaxan® related to the daily dose of 4 Cl (40 ml) Composition: Rosehip puree 20.0 g
Rosehip juice concentrate 4.0 g
Nettle extract 160 mg
Devil's claw root powd
Sponsors
medAgil Gesundheitsgesellschaft mbH
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: 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
| Measure | Time frame |
|---|---|
| Secondary outcomes measures: Differences between verum and Placebo group: • changes in the WOMAC index "pain" after 6 weeks • changes in the WOMAC global index after 6 and 12 weeks • changes in the WOMAC indices "function" and "stiffness" after 6 and 12 weeks • Changes in quality of life (SF-12) after 6 and 12 weeks • change in analgesics consumption during the study period • adverse events occurrence (UE) during the study period • Global evaluation of efficacy and tolerability by investigator and patient after 12 weeks | — |
Countries
Germany
Contacts
Public ContactRalf Uebelhack
Prüfzentrumanalyze & realize GmbH
Outcome results
None listed