Back to resultsEffects Of Native Collagen Type 2 Treatment
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
paracetamol
paracetamol+native collagen type 2
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, native collagen type 2, paracetamol
Eligibility Criteria
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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Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
paracetamol
native collagen type 2 + paracetamol
Arm Description
The 1st group includes 19 patients given 1500mg/day paracetamol for three months
The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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
the Change From Baseline in Coll2-1 Levels
Post treatment comparison of Coll2-1 levels between groups
Full Information
NCT ID
NCT02237989
First Posted
September 10, 2014
Last Updated
September 17, 2020
Sponsor
Eskisehir Osmangazi University
1. Study Identification
Unique Protocol Identification Number
NCT02237989
Brief Title
Effects Of Native Collagen Type 2 Treatment
Official Title
Effects Of Native Collagen Type 2 Treatment In Knee Osteoarthritis : A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir Osmangazi University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis, native collagen type 2, paracetamol
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
paracetamol
Arm Type
Active Comparator
Arm Description
The 1st group includes 19 patients given 1500mg/day paracetamol for three months
Arm Title
native collagen type 2 + paracetamol
Arm Type
Experimental
Arm Description
The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months
Intervention Type
Drug
Intervention Name(s)
paracetamol
Intervention Description
1500 mg
Intervention Type
Drug
Intervention Name(s)
paracetamol+native collagen type 2
Intervention Description
paracetamol (1500 mg) + native collagen type 2 (10mg)
Primary Outcome Measure Information:
Title
the Change From Baseline in Pain During Walking Visual Analog Scale (VAS Walking)
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
the Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
Description
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.
Time Frame
3 months
Title
the Change From Baseline in 20 Meters Walking Time
Description
Post treatment comparison of 20 meters walking time between the groups When the time increases, clinical of the patient worses
Time Frame
3 months
Title
the Change From Baseline in Short Form 36 / Bodily Pain Subgroup
Description
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
Time Frame
3 months
Title
the Change From Baseline in Coll2-1 Levels
Description
Post treatment comparison of Coll2-1 levels between groups
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fulya Bakilan, Specialist
Organizational Affiliation
Yerkoy State Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
27551171
Citation
Bakilan F, Armagan O, Ozgen M, Tascioglu F, Bolluk O, Alatas O. Effects of Native Type II Collagen Treatment on Knee Osteoarthritis: A Randomized Controlled Trial. Eurasian J Med. 2016 Jun;48(2):95-101. doi: 10.5152/eurasianjmed.2015.15030.
Results Reference
derived
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Effects Of Native Collagen Type 2 Treatment
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