The Safety and Efficacy of an Enzyme Combination in Managing Knee Osteoarthritis Pain in Adults

Study Overview
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Brief Summary
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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.

Official Title
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The Safety and Efficacy of an Enzyme Combination in Managing Knee Osteoarthritis Pain in Adults: a Randomized, Double-blind, Placebo-controlled Trial.

Conditions
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Wobenzym, Osteoarthritis

Intervention / Treatment
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* Drug: Diclofenac
* Dietary Supplement: Wobenzym
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diclofenac<br>Subjects assigned to receive 1 tablet of Diclofenac Sodium (50 mg) and two tablets of an indistinguishable placebo three times daily for a duration of 12 weeks. | Drug: Diclofenac<br> <br> |
| Active Comparator: Wobenzym<br>Subjects assigned to receive 2 tablets of Wobenzym(R) and 1 tablet of an indistinguishable placebo three times daily for a duration of 12 weeks. | Dietary Supplement: Wobenzym<br> <br> |
| Placebo Comparator: Placebo<br>Subjects assigned to receive three tablets of an indistinguishable placebo three times daily for a duration of 12 weeks. | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Change from baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Index version 3.0 subscale for pain (WOMAC-A) |  | Change from baseline to 12 weeks | 
| 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 | 
| Paracetamol Consumption | Number of paracetamol tablets consumed during the study by subjects | 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 | Change from baseline to 12 weeks | 
| Adverse Events | Any complications throughout study. | Through baseline to 12 weeks |