Title

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

    N/A
  • Study Type

    Interventional
  • Study Participants

    39
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.
Study Started
Jan 31
2013
Primary Completion
Dec 31
2013
Study Completion
Dec 31
2013
Results Posted
Sep 18
2020
Last Update
Sep 18
2020

Drug paracetamol

1500 mg

Drug paracetamol+native collagen type 2

paracetamol (1500 mg) + native collagen type 2 (10mg)

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

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

-

Summary

Treatment Group

Control Group

All Events

Event Type Organ System Event Term

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.

Paracetamol

3.0
score on a scale (Median)
Inter-Quartile Range: 0.0 to 9.0

Native Collagen Type 2 + Paracetamol

3.0
score on a scale (Median)
Inter-Quartile Range: 0.0 to 9.0

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.

Paracetamol

52.0
units on a scale (Median)
Inter-Quartile Range: 24.0 to 100.0

Native Collagen Type 2 + Paracetamol

44.0
units on a scale (Median)
Inter-Quartile Range: 24.0 to 100.0

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

Paracetamol

18.84
seconds (Mean)
Standard Deviation: 4.79

Native Collagen Type 2 + Paracetamol

18.0
seconds (Mean)
Standard Deviation: 3.49

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

Paracetamol

51.0
score (Median)
Inter-Quartile Range: 10.0 to 100.0

Native Collagen Type 2 + Paracetamol

52.0
score (Median)
Inter-Quartile Range: 10.0 to 84.0

the Change From Baseline in Coll2-1 Levels

Post treatment comparison of Coll2-1 levels between groups

Paracetamol

130.0
microgram/ml (Median)
Inter-Quartile Range: 22.4 to 596.13

Native Collagen Type 2 + Paracetamol

155.25
microgram/ml (Median)
Inter-Quartile Range: 26.84 to 558.01

Total

39
Participants

Age, Continuous

58.2
years (Mean)
Standard Deviation: 7.8

Ethnicity (NIH/OMB)

Region of Enrollment

Sex: Female, Male

Overall Study

Paracetamol

Native Collagen Type 2 + Paracetamol