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Effects Of Native Collagen Type 2 Treatment

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ClinicalTrials.gov Identifier: NCT02237989
Recruitment Status : Completed
First Posted : September 12, 2014
Last Update Posted : September 12, 2014
Sponsor:
Information provided by (Responsible Party):
Onur Armağan, Eskisehir Osmangazi University

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : January 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Collagen

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)




Primary Outcome Measures :
  1. the change from baseline in pain at rest and during walking [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. the change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 3 months ]
  2. the change from baseline in 20 meters walking time [ Time Frame: 3 months ]
  3. the change from baseline in short form 36 [ Time Frame: 3 months ]
  4. the change from baseline in Coll2-1, Coll2-1NO2 and Fibulin-3 levels in urine [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02237989


Sponsors and Collaborators
Eskisehir Osmangazi University
Investigators
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Study Director: Fulya Bakilan, Specialist Yerkoy State Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Onur Armağan, Onur Armagan, Medical Doctor, Eskisehir Osmangazi University
ClinicalTrials.gov Identifier: NCT02237989     History of Changes
Other Study ID Numbers: FY2001
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: September 12, 2014
Last Verified: December 2013

Keywords provided by Onur Armağan, Eskisehir Osmangazi University:
knee osteoarthritis, native collagen type 2, paracetamol

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics