Hydrolyzed Collagen and Undenatured Collagen Type II in OA Knee

Osteo Arthritis Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06229951
• Other study ID #: 66-304-11-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 20, 2024
• Est. completion date: March 30, 2025

Study information

• Verified date: January 2024
• Source: Prince of Songkla University
• Contact: Varah Yuenyongviwat, M.D.
• Phone: 6674451601
• Email: varah.y[@]psu.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: March 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Dietary Supplement:
• Collagen
Patients who have taken 480 mg of hydrolyzed collagen and 20 mg of undenatured type II collagen (in one tablet) twice a day

Other:
• Placebo
Control patients will take placebo twice a day.

Locations

Country	Name	City	State
Thailand	Prince of Songkla University	Hat Yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain (VNRS)	Pain level (verbal numerical rating scale :VNRS) - 0 is no pain and 10 is the worst pain	first, 2 weeks, 6 weeks, 12 weeks
Secondary	Knee and Osteoarthritis Outcome Score (KOOS)	Knee and Osteoarthritis Outcome Score (KOOS) - 100 indicates the best possible results and 0 the worst outcome	first, 2 weeks, 6 weeks, 12 weeks
Secondary	Rescue medication	Amount of pain medication intake	first, 2 weeks, 6 weeks, 12 weeks
Secondary	Patient satisfaction	Patient satisfaction (verbal numerical rating scale :VNRS) - (0-10; 0=worst and 10=best)	first, 2 weeks, 6 weeks, 12 weeks