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Clinical trial to evaluate efficacy and safety of low molecular collagen peptides for joint pai

Not Applicable
Completed
Conditions
Diseases of the musculoskeletal system and connective tissue
Registration Number
KCT0007584
Lead Sponsor
Yonsei University Health System, Severance Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
78
Inclusion Criteria

(1) Adult men and women aged 40 years or older and less than 75 years old for more than 6 months after being diagnosed with knee arthritis
(2) Those whose Kellgren-Lawrence grading scale of one or both knee joints is grade I or II in simple radiographic examination
(3) Those who have knee arthritis pain score of 30 mm or more evaluated by the Visual analog scale (VAS-100 mm)
(4) Those with a body mass index (BMI) of less than 30 kg/m2

Exclusion Criteria

(1) Those who have been diagnosed with inflammatory arthritis such as rheumatoid arthritis or lupus arthritis, or have been diagnosed with secondary osteoarthritis due to systemic disease, etc.
(2) Those with gout, recurrent pseudogout
(3) Those who have infection or severe inflammation of the knee joint, such as septic arthritis
(4) If there is a lower extremity fracture within the last 3 months
(5) Persons with a history of clinically significant hypersensitivity to collagen components
(6) Those who cannot stop taking drugs or health functional foods that affect knee joint pain during the test period from 2 weeks before the first intake of food for human application testing

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in Western Ontario and McMaster Universities (WOMAC) pain score after 12 weeks from baseline
Secondary Outcome Measures
NameTimeMethod
Changes in VAS (Visual Analogue Scale) after 6 weeks and 12 weeks from baseline;Change in WOMAC pain score after 6 weeks from baseline
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