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OpenTrials
Completed

NCT Number: NCT06229951

Hydrolyzed Collagen and Undenatured Collagen Type II in OA Knee

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

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Key information

Conditions

Osteo Arthritis Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Collagen

Dietary Supplement

Patients who have taken 480 mg of hydrolyzed collagen and 20 mg of undenatured type II collagen (in one tablet) 2 tabs a day

Placebo

Other

Control patients will take placebo 2 tabs a day.

Primary outcomes

  1. 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

  1. Knee and Osteoarthritis Outcome Score (KOOS)

    Time frame: 12 weeks

    Knee and Osteoarthritis Outcome Score (KOOS) - 100 indicates the best possible results and 0 the worst outcome

  2. Rescue medication

    Time frame: 12 weeks

    Amount of pain medication intake

  3. Patient satisfaction

    Time frame: 12 weeks

    Patient satisfaction (verbal numerical rating scale :VNRS) - (0-10; 0=worst and 10=best)

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 29, 2024
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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