Effects Of Native Collagen Type 2 Treatment

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02237989
• Other study ID #: FY2001
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 2013

Study information

• Verified date: September 2020
• Source: Eskisehir Osmangazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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

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Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• paracetamol
1500 mg
• paracetamol+native collagen type 2
paracetamol (1500 mg) + native collagen type 2 (10mg)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	the Change From Baseline in Coll2-1 Levels	Post treatment comparison of Coll2-1 levels between groups	3 months