Hydrolyzed Collagen and Undenatured Collagen Type II in OA Knee

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06229951

Enrollment

Registered

2024-01-29

Start date

2023-11-01

Completion date

2024-11-30

Last updated

2024-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteo Arthritis Knee

Keywords

Osteoarthritis, Collagen supplement

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

Interventions

OTHERPlacebo

Control patients will take placebo 2 tabs a day.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Pain (VNRS)	12 weeks	Pain level (verbal numerical rating scale :VNRS) - 0 is no pain and 10 is the worst pain

Secondary

Measure	Time frame	Description
Knee and Osteoarthritis Outcome Score (KOOS)	12 weeks	Knee and Osteoarthritis Outcome Score (KOOS) - 100 indicates the best possible results and 0 the worst outcome
Rescue medication	12 weeks	Amount of pain medication intake
Patient satisfaction	12 weeks	Patient satisfaction (verbal numerical rating scale :VNRS) - (0-10; 0=worst and 10=best)

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026