Effects Of Native Collagen Type 2 Treatment

• Sponsor: Eskisehir Osmangazi University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02237989
• Collaborator: (none)
• Enrollment: 39
• Arms: 2
• Duration (Months): 11

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Drug: paracetamol; Drug: paracetamol+native collagen type 2	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects Of Native Collagen Type 2 Treatment In Knee Osteoarthritis : A Randomized Controlled Trial
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: paracetamol The 1st group includes 19 patients given 1500mg/day paracetamol for three months	Drug: paracetamol; 1500 mg
Experimental: 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	Drug: paracetamol+native collagen type 2; paracetamol (1500 mg) + native collagen type 2 (10mg)

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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

3. 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

4. the Change From Baseline in Coll2-1 Levels [3 months]

   Post treatment comparison of Coll2-1 levels between groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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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Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Eskisehir Osmangazi University

Investigators

• Study Director: Fulya Bakilan, Specialist, Yerkoy State Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Onur Armağan, Onur Armagan, Medical Doctor, Eskisehir Osmangazi University
• ClinicalTrials.gov Identifier: NCT02237989
• Other Study ID Numbers: FY2001
• First Posted: Sep 12, 2014
• Last Update Posted: Sep 18, 2020
• Last Verified: Sep 1, 2020

• Keywords provided by Onur Armağan, Onur Armagan, Medical Doctor, Eskisehir Osmangazi University: knee osteoarthritis, native collagen type 2, paracetamol
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Acetaminophen

Study Results

Participant Flow

Arm/Group Title	Paracetamol	Native Collagen Type 2 + Paracetamol
Arm/Group Description	The 1st group includes 19 patients given 1500mg/day paracetamol for three months paracetamol: 1500 mg	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)
Period Title: Overall Study
STARTED	19	20
COMPLETED	19	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Paracetamol	Native Collagen Type 2 + Paracetamol	Total
Arm/Group Description	The 1st group includes 19 patients given 1500mg/day paracetamol for three months paracetamol: 1500 mg	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)	Total of all reporting groups
Overall Participants	19	20	39
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.84 (6.55)	57.65 (8.73)	58.2 (7.8)
Sex: Female, Male (Count of Participants)
Female	17 89.5%	19 95%	36 92.3%
Male	2 10.5%	1 5%	3 7.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	0 0%	0 0%	0 0%
Unknown or Not Reported	19 100%	20 100%	39 100%
Region of Enrollment (participants) [Number]
Turkey	19 100%	20 100%	39 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paracetamol	Native Collagen Type 2 + Paracetamol
Arm/Group Description	The 1st group includes 19 patients given 1500mg/day paracetamol for three months paracetamol: 1500 mg	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)
Measure Participants	19	20
Median (Inter-Quartile Range) [score on a scale]	3	3

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paracetamol	Native Collagen Type 2 + Paracetamol
Arm/Group Description	The 1st group includes 19 patients given 1500mg/day paracetamol for three months paracetamol: 1500 mg	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)
Measure Participants	19	20
Median (Inter-Quartile Range) [units on a scale]	52	44

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paracetamol	Native Collagen Type 2 + Paracetamol
Arm/Group Description	The 1st group includes 19 patients given 1500mg/day paracetamol for three months paracetamol: 1500 mg	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)
Measure Participants	19	20
Mean (Standard Deviation) [seconds]	18.84 (4.79)	18 (3.49)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paracetamol	Native Collagen Type 2 + Paracetamol
Arm/Group Description	The 1st group includes 19 patients given 1500mg/day paracetamol for three months paracetamol: 1500 mg	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)
Measure Participants	19	20
Median (Inter-Quartile Range) [score]	51	52

5. Secondary Outcome

Title	the Change From Baseline in Coll2-1 Levels
Description	Post treatment comparison of Coll2-1 levels between groups
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paracetamol	Native Collagen Type 2 + Paracetamol
Arm/Group Description	The 1st group includes 19 patients given 1500mg/day paracetamol for three months paracetamol: 1500 mg	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)
Measure Participants	19	20
Median (Inter-Quartile Range) [microgram/ml]	130	155.25

Adverse Events

Time Frame	3 months
Arm/Group Title	Treatment Group		Control Group
Arm/Group Description	1500 mg/day acetaminophen and 10 mg/day of native type II collagen		1500 mg/day acetaminophen
All Cause Mortality
	Treatment Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/19 (0%)
Serious Adverse Events
	Treatment Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Treatment Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.