KCT0005507
Completed
未知
Randomized, double-blind, and controlled clinical study for improvement of articular cartilage via the analysis of effect of low molecular weight collagen peptide
Pusan National University Korean Medicine Hospital0 sites80 target enrollmentTBD
ConditionsNot Applicable
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not Applicable
- Sponsor
- Pusan National University Korean Medicine Hospital
- Enrollment
- 80
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adult aged 40 years or older and under 75 years old
- •2\. Persons with grade I or II Kellgren\-Lawrence grading scale of one or both knee joints in simple radiographic examination
- •3\. Persons with a knee arthritis pain score of 30 ? or more evaluated with a visual analog scale (VAS\-100 ?)
- •4\. Applicants who are capable of normal physical activity and have consented in writing to the test agreement
Exclusion Criteria
- •1\. Those who are currently being treated for clinically significant acute or chronic cardio\-cerebrovascular, immune system, respiratory system, hepatobiliary system, kidney and urinary system, nervous system, musculoskeletal disease, mental, infectious and blood, neoplastic disease
- •2\. Those who have undergone artificial knee replacement surgery or plan to receive it during the human application test period.
- •3\. Those who have been diagnosed with inflammatory arthritis such as rheumatoid arthritis or lupus arthritis, or who have been diagnosed with secondary osteoarthritis due to systemic diseases.
- •4\. People with gout or recurrent pseudo gout
- •5\. Those with infection or severe inflammation of the knee joint such as septic arthritis
- •6\. Those who had a fracture of the leg within the last 3 months
- •7\. Those with a history of clinically significant hypersensitivity reactions to collagen components
- •8\. Patients with uncontrolled hypertension (measured after 10 minutes of rest for subjects with blood pressure of 160/100 ?Hg or more)
- •9\. Creatinine is more than twice the normal upper limit of the laboratory
- •10\. Those whose AST (GOT) and ALT (GPT) are more than 2\.5 times the normal upper limit of the laboratory
Outcomes
Primary Outcomes
Not specified
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