Hydrolyzed Collagen and Undenatured Collagen Type II in OA Knee

NCT06229951 | Completed DMC

• 1 other identifier: 66-304-11-1
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Conditions

Osteo Arthritis Knee

Keywords

Osteoarthritis; Collagen supplement

Outcome Measures

Primary Outcomes (1)

• Pain (VNRS)

  Pain level (verbal numerical rating scale :VNRS) - 0 is no pain and 10 is the worst pain

  12 weeks

Secondary Outcomes (3)

• Knee and Osteoarthritis Outcome Score (KOOS)

  12 weeks

• Rescue medication

  12 weeks

• Patient satisfaction

  12 weeks

Study Arms (2)

Collagen supplement group

EXPERIMENTAL

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

Dietary Supplement: Collagen

Control group

PLACEBO COMPARATOR

Control patients will take placebo 2 tabs a day

Other: Placebo

Interventions

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

Collagen supplement group

Placebo OTHER

Control patients will take placebo 2 tabs a day.

Control group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 50-80 years old
• Medial compartment knee osteoarthritis
• Kellgren and Lawrence classification stage 2 -3
• Able to walk without walking aid

You may not qualify if:

• 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)

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Related Publications (1)

• Yuenyongviwat V, Anusitviwat C, Tuntarattanapong P, Hongnaparak T, Iamthanaporn K. Efficacy of combined undenatured type II collagen and hydrolysed collagen supplementation in knee osteoarthritis: a randomised controlled trial. Sci Rep. 2025 Sep 2;15(1):32313. doi: 10.1038/s41598-025-17505-0.

  PMID: 40897777 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Collagen

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Biopolymers; Polymers; Macromolecular Substances; Extracellular Matrix Proteins; Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 29, 2024
• Study Start: November 1, 2023
• Primary Completion: August 31, 2024
• Study Completion: November 30, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will become available and for 1 year after publication.
• Access Criteria: Open Science Framework (OSF)

Locations

TH (1)