Osteoarthritis, Wobenzym
Conditions
Brief summary
The aim of this randomized, double-blind, placebo-controlled, comparator-controlled trial was to evaluate the safety and efficacy of an enzyme combination, as Wobenzym®, in adults with moderate-to-severe osteoarthritis (OA) of the knee.
Interventions
Sponsors
Mucos Pharma GmbH, Oberhaching, Germany
Atrium Innovations
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Knee osteoarthritis confirmed by radiography or tomography * Lequesne Functional Index score of 10-14 * WOMAC-A pain subscale score greater than or equal to 25
Exclusion criteria
* History of knee trauma * History of joint infection * History of joint surgery * History of intra-articular injection (viscotherapy) * History of gastrointestinal diseases * Use of corticosteroids * Use of COX-II inhibitors * Use of glucosamine/chondroitin * Known sensitivity to paracetamol * Known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) * Known sensitivity to oral enzymes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lequesne Functional Index | Change from baseline to 12 weeks | Self-assessment of the affected knee joint by physician interview using the Lequesne Functional Index (providing an estimate of the degree of pain associated with the affected joint, the maximum distance talked, and activities of daily living). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities Index version 3.0 subscale for joint stiffness (WOMAC-B) | Change from baseline to 12 weeks | — |
| Western Ontario and McMaster Universities Index version 3.0 subscale for joint function (WOMAC-C) | Change from baseline to 12 weeks | — |
| Western Ontario and McMaster Universities Index version 3.0 subscale for pain (WOMAC-A) | Change from baseline to 12 weeks | — |
| Indices of systemic inflammation | Change from baseline to 12 weeks | Erythrocyte sedimentation rates at 1 and 2 hours and serum concentration of C-reactive protein |
| Adverse Events | Through baseline to 12 weeks | Any complications throughout study. |
| Paracetamol Consumption | Change from baseline to 12 weeks | Number of paracetamol tablets consumed during the study by subjects |
Countries
Germany
Outcome results
None listed