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Clinical Trials/NCT06229951
NCT06229951
Completed
Not Applicable

Efficacy of Hydrolyzed Collagen and Undenatured Collagen Type II in Alleviating Pain in Patients With Knee Osteoarthritis

Prince of Songkla University1 site in 1 country68 target enrollmentNovember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteo Arthritis Knee
Sponsor
Prince of Songkla University
Enrollment
68
Locations
1
Primary Endpoint
Pain (VNRS)
Status
Completed
Last Updated
last year

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

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
November 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Varah Yuenyongviwat

Professor

Prince of Songkla University

Eligibility Criteria

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)

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

  • Knee and Osteoarthritis Outcome Score (KOOS)(12 weeks)
  • Rescue medication(12 weeks)
  • Patient satisfaction(12 weeks)

Study Sites (1)

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