Knee Osteoarthritis Clinical Trial
Official title:
A 6 Week, Double Blind, Placebo-controlled, Multi-center Pilot Study Evaluating the Efficacy of Wobenzym(R)N at Reducing Pain Severity as Measured by the WOMAC Pain Score in Subjects With Knee Osteoarthritis
The objective of this study is to determine the most effective dose of Wobenzym® N versus placebo at reducing pain severity as measured by the WOMAC pain score in subjects with symptomatic knee osteoarthritis (OA) at 6 weeks of treatment.
Osteoarthritis (OA) is the most common disease of the joints. The main symptom of OA is pain
and later followed by stiffness and decreased function of the joints. It is estimated to
affect more than 100 million people worldwide, substantially decreasing their quality of
their life. Treatment that can relieve the disease symptoms and more particularly the pain
level can greatly improve the quality of life and function of patients suffering from OA of
weight-bearing joints such as the knee. Wobenzym® N is a fixed compound made of plant and
animal enzyme products with the non-enzymatic component rutin recommended for the treatment
of musculoskeletal disorders. The Wobenzym® N formulation contains, per tablet: pancreatin
100 mg, trypsin 24 mg and chymotrypsin 1 mg (from pancreas); bromelain 45 mg; papain 60 mg;
and rutin 50 mg.
Over 50 clinical studies have been conducted using similar oral proteolytic enzyme
preparations-- Wobenzym® and Phlogenzym®-- with consistently positive findings related to
rheumatoid arthritis, sprains and strains, reduction of C-reactive protein, sports injuries
and joint and muscular pain, as well as OA of the knee. Several comparative studies
conducted with Phlogenzym®, an oral enzyme-rutin combination containing bromelain 90 mg,
trypsin 48 mg and rutin 100 mg, have proved the product to be effective and safe in the
treatment of OA as compared to NSAIDs. [For review, see Leipner, et al. Biodrugs
2001;15(12):779-89.]
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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