Efficacy of Hydrolyzed Collagen and Undenatured Collagen Type II in Alleviating Pain in Patients With Knee Osteoarthritis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Prince of Songkla University
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Pain (VNRS)
Study Overview
Brief Summary
Randomized controlled trial
Targeted patients who come to receive treatment for osteoarthritis that meets the research indications will be assigned to a random group by the box of 4 randomization method, with a sequence that is randomly generated by a computer. The groups are divided into two groups:
Group 1: Patients who have taken 480 mg of hydrolyzed collagen and 20 mg of undenatured type II collagen
Group 2: Control patients will take placebo
Primary outcome : Pain level
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: 50-80 years old
- •Medial compartment knee osteoarthritis
- •Kellgren and Lawrence classification stage 2 -3
- •Able to walk without walking aid
Exclusion Criteria
- •History of knee surgery on the study side
- •History of intra-articular steroid injection within 6 months prior to study entry
- •Systemic arthritis conditions
- •Degenerative neurological and muscular conditions in the lower extremities
- •Chronic kidney disease with CrCl < 30 ml/min (glomerular filtration rate <60 mL/min/1.73 m2)
Arms & Interventions
Control group
Control patients will take placebo 2 tabs a day
Intervention: Placebo (Other)
Collagen supplement group
Patients who have taken 480 mg of hydrolyzed collagen and 20 mg of undenatured type II collagen (in one tablet) 2 tabs a day
Intervention: Collagen (Dietary Supplement)
Outcomes
Primary Outcomes
Pain (VNRS)
Time Frame: 12 weeks
Pain level (verbal numerical rating scale :VNRS) - 0 is no pain and 10 is the worst pain
Secondary Outcomes
- Rescue medication(12 weeks)
- Knee and Osteoarthritis Outcome Score (KOOS)(12 weeks)
- Patient satisfaction(12 weeks)
Investigators
Varah Yuenyongviwat
Professor
Prince of Songkla University