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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Mucos Pharma GmbH & Co
Oberhaching, Germany
Lequesne Functional Index
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).
Time frame: Change from baseline to 12 weeks
Western Ontario and McMaster Universities Index version 3.0 subscale for pain (WOMAC-A)
Time frame: Change from baseline to 12 weeks
Western Ontario and McMaster Universities Index version 3.0 subscale for joint stiffness (WOMAC-B)
Time frame: Change from baseline to 12 weeks
Western Ontario and McMaster Universities Index version 3.0 subscale for joint function (WOMAC-C)
Time frame: Change from baseline to 12 weeks
Paracetamol Consumption
Number of paracetamol tablets consumed during the study by subjects
Time frame: Change from baseline to 12 weeks
Indices of systemic inflammation
Erythrocyte sedimentation rates at 1 and 2 hours and serum concentration of C-reactive protein
Time frame: Change from baseline to 12 weeks
Adverse Events
Any complications throughout study.
Time frame: Through baseline to 12 weeks
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