Hydrolyzed Collagen and Undenatured Collagen Type II in OA Knee

Not Applicable

Completed

• Conditions: Osteo Arthritis Knee
• Interventions: Dietary Supplement: Collagen; Other: Placebo

• Registration Number: NCT06229951
• Lead Sponsor: Prince of Songkla University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Study First Submitted: 2024-01-16
• Study First Submitted QC: 2024-01-25
• Study First Posted: 2024-01-29
• Primary Completion: 2024-08-31
• Study Completion: 2024-11-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collagen supplement group	Collagen	Patients who have taken 480 mg of hydrolyzed collagen and 20 mg of undenatured type II collagen (in one tablet) twice a day
Control group	Placebo	Control patients will take placebo twice a day

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Prince of Songkla University; 🇹🇭 Hat Yai, Songkhla, Thailand