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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paracetamol | Active Comparator | The 1st group includes 19 patients given 1500mg/day paracetamol for three months |
|
| native collagen type 2 + paracetamol | Experimental | The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paracetamol | Drug | 1500 mg |
| |
| paracetamol+native collagen type 2 |
| 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 |
| 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 |
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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
-
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| Name | Affiliation | Role |
|---|---|---|
| Fulya Bakilan, Specialist | Yerkoy State Hospital | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27551171 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Paracetamol | The 1st group includes 19 patients given 1500mg/day paracetamol for three months paracetamol: 1500 mg |
| FG001 | Native Collagen Type 2 + Paracetamol | The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months paracetamol+native collagen type 2: paracetamol (1500 mg) + native collagen type 2 (10mg) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Paracetamol | The 1st group includes 19 patients given 1500mg/day paracetamol for three months paracetamol: 1500 mg |
| BG001 | Native Collagen Type 2 + Paracetamol | The 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months paracetamol+native collagen type 2: paracetamol (1500 mg) + native collagen type 2 (10mg) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | score on a scale | 3 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | 1500 mg/day acetaminophen and 10 mg/day of native type II collagen |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Fulya Bakılan | Eskisehir Osmangazi University | +905057737335 | fulyabakilan@gmail.com |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Drug |
paracetamol (1500 mg) + native collagen type 2 (10mg) |
|
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | 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 | Posted | Mean | Standard Deviation | seconds | 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 | Posted | Median | Inter-Quartile Range | score | 3 months |
|
|
|
| Secondary | the Change From Baseline in Coll2-1 Levels | Post treatment comparison of Coll2-1 levels between groups | Posted | Median | Inter-Quartile Range | microgram/ml | 3 months |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Control Group | 1500 mg/day acetaminophen | 0 | 19 | 0 | 19 | 0 | 19 |
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| D012216 |
| Rheumatic Diseases |
| Aniline Compounds |
| D000588 | Amines |