Effects Of Native Collagen Type 2 Treatment

Not Applicable

Completed

Conditions: Knee Osteoarthritis

Interventions: Drug: paracetamol+native collagen type 2
Drug: paracetamol

Registration Number: NCT02237989

Lead Sponsor: Eskisehir Osmangazi University

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 39

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
native collagen type 2 + paracetamol	paracetamol+native collagen type 2	The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months
paracetamol	paracetamol	The 1st group includes 19 patients given 1500mg/day paracetamol for three months

Primary Outcome Measures

Name	Time	Method
the Change From Baseline in Pain During Walking Visual Analog Scale (VAS Walking)	3 months	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.

Secondary Outcome Measures

Name	Time	Method
the Change From Baseline in Coll2-1 Levels	3 months	Post treatment comparison of Coll2-1 levels between groups
the Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score	3 months	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.
the Change From Baseline in 20 Meters Walking Time	3 months	Post treatment comparison of 20 meters walking time between the groups When the time increases, clinical of the patient worses
the Change From Baseline in Short Form 36 / Bodily Pain Subgroup	3 months	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