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CompletedNCT06229951Updated Dec 24, 2024

Hydrolyzed Collagen and Undenatured Collagen Type II in OA Knee

An interventional study of Collagen and Placebo in Osteo Arthritis Knee, sponsored by Prince of Songkla University. Completed at 1 site in Thailand. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-24.

Sponsored by Prince of Songkla University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
All
01

Study 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

02

Conditions studied

  • Osteo Arthritis Knee

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Keywords

  • Osteoarthritis
  • Collagen supplement
03

In context

Osteoarthritis

4,445 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 68 is close to the median of 70 across 3,474 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Prince of Songkla University is the lead sponsor of 116 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    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

    Dietary Supplement: Collagen

  • Placebo comparator
    Control group

    Control patients will take placebo 2 tabs a day

    Other: Placebo

Interventions

  • Dietary supplementCollagen

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

  • OtherPlacebo

    Control patients will take placebo 2 tabs a day.

06

What researchers measure

Primary outcomes

  1. Pain (VNRS)

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

    Time frame: 12 weeks

Secondary outcomes

  1. Knee and Osteoarthritis Outcome Score (KOOS)

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

    Time frame: 12 weeks

  2. Rescue medication

    Amount of pain medication intake

    Time frame: 12 weeks

  3. Patient satisfaction

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

    Time frame: 12 weeks

07

Study locations

1 site
  • Prince of Songkla University
    Hat Yai, Changwat Songkhla 90110, Thailand
08

References and documents

Publications

  • 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. PubMed 40897777 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Clinical study report

Time frame: Data will become available and for 1 year after publication.

Access criteria: Open Science Framework (OSF)

Data sharing details ↗ · osf.io

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2023 to primary completion in Aug 2024, 9 months.

Of 1,126 non-industry interventional studies with no phase under Osteoarthritis, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's 9 months is below that.

Counting every sponsor, half of 1,315 studies reached it within 19 months; a quarter within 8 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 16, 2024
First posted
Jan 29, 2024
StartActual
Nov 1, 2023
Primary completionActual
Aug 31, 2024
CompletionActual
Nov 30, 2024
Last update
Dec 24, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06229951
Responsible party
Varah Yuenyongviwat (Professor, Prince of Songkla University) — Principal investigator
First posted
Jan 29, 2024
Start date
Nov 1, 2023
Primary completion
Aug 31, 2024
Completion
Nov 30, 2024
Last update
Dec 24, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Collagen

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