Effects Of Native Collagen Type 2 Treatment

Study Overview
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Brief Summary
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The aim of this study was to evaluate symptomatic efficacy of native collagen type 2 on joint pain and function and its effects on urinary biological markers related to cartilage degeneration in patients with knee osteoarthritis.

Detailed Description
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39 patients diagnosed with knee osteoarthritis were separated into two groups. The 1st group includes 19 patients given 1500mg/day paracetamol, the 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months.Pretreatment and posttreatment Visual Analog Scale, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), 20-m walking time and Short Form-36 (SF-36), Coll2-1, Coll2-1NO2 and Fibulin-3 levels in urine were compared.

Official Title
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Effects Of Native Collagen Type 2 Treatment In Knee Osteoarthritis : A Randomized Controlled Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Drug: paracetamol
* Drug: paracetamol+native collagen type 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:Patients aged 45-70 years with the diagnosis of primary knee OA according to the American College of Rheumatology (ACR) criteria, Kellgren Lawrence radiological stage II or III and knee pain - Exclusion Criteria:Patients with intraarticular injections or physical therapy within the last year, a previous lower extremity surgery, oral treatment with glucosamine chondroitin or other natural health products within the last month, serious concomitant systemic diseases, peripheral or central neurological disorder, hypersensitivity to paracetamol or se¬vere cardiac, renal, hepatic, hematologic disease -

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: paracetamol<br>The 1st group includes 19 patients given 1500mg/day paracetamol for three months | Drug: paracetamol<br>* 1500 mg<br>|
| Experimental: native collagen type 2 + paracetamol<br>The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months | Drug: paracetamol+native collagen type 2<br>* paracetamol (1500 mg) + native collagen type 2 (10mg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Change From Baseline in Pain During Walking Visual Analog Scale (VAS Walking) | Post treatment comparison of VAS walking between the groups minimum score is 0, maximum score is 10. The clinic of the patient worses when the score increases. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score | Post treatment comparison of WOMAC between the groups minimum score is 0, maximum score is 100. The clinic of the patient worses when the score increases. | 3 months | 
| the Change From Baseline in 20 Meters Walking Time | Post treatment comparison of 20 meters walking time between the groups When the time increases, clinical of the patient worses | 3 months | 
| the Change From Baseline in Short Form 36 / Bodily Pain Subgroup | Post treatment comparison of short form 36-bodily pain between groups minimum score 0 maximum score 100 When the score increases, clinic of patient gets better | 3 months | 
| the Change From Baseline in Coll2-1 Levels | Post treatment comparison of Coll2-1 levels between groups | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee osteoarthritis, native collagen type 2, paracetamol