Effects Of Native Collagen Type 2 Treatment
1 other identifier
interventional
39
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable knee-osteoarthritis
Started Jan 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 10, 2014
CompletedFirst Posted
Study publicly available on registry
September 12, 2014
CompletedResults Posted
Study results publicly available
September 18, 2020
CompletedSeptember 18, 2020
September 1, 2020
11 months
September 10, 2014
August 13, 2020
September 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
the Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
3 months
the Change From Baseline in 20 Meters Walking Time
3 months
the Change From Baseline in Short Form 36 / Bodily Pain Subgroup
3 months
the Change From Baseline in Coll2-1 Levels
3 months
Study Arms (2)
paracetamol
ACTIVE COMPARATORThe 1st group includes 19 patients given 1500mg/day paracetamol for three months
native collagen type 2 + paracetamol
EXPERIMENTALThe 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months
Interventions
paracetamol (1500 mg) + native collagen type 2 (10mg)
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 27551171DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Fulya Bakılan
- Organization
- Eskisehir Osmangazi University
Study Officials
- STUDY DIRECTOR
Fulya Bakilan, Specialist
Yerkoy State Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Onur Armagan, Medical Doctor
Study Record Dates
First Submitted
September 10, 2014
First Posted
September 12, 2014
Study Start
January 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
September 18, 2020
Results First Posted
September 18, 2020
Record last verified: 2020-09