None listed
Conditions
Interventions
Others : Treatment: Low molecular weight collagen peptide(700mg), 3 capsules/time, 2 times/day, total 4,200mg/day
Placebo: Placebo capsule(740mg), 3 capsules/time, 2 times/day, total 4,440mg/day
Sponsors
Pusan National University Korean Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion 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
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 11. Persons who received the following drugs before the first consumption of food for human application test -Those who received hyaluronic acid or steroid administration to the knee joint within 1 month from the time of screening test -Those who have systemically used steroids within 1 month from the time of screening test (except topical application and inhalation) -Those who took drugs that affect knee joint pain, such as NSAID, glucosamine, and chondroitin sulfate, within 1 month before the first ingestion of the human test food 12. Persons who cannot stop drugs or health functional foods that affect knee pain during the test period from 1 month before the first intake of human test food 13. Those who have participated in or plan to participate in other clinical trials within the last 1 month 14. Those who are judged to interfere with the test due to excessive alcohol consumption 15. Pregnant or nursing mothers who plan to become pregnant during this human application test 16. Those with a body mass index (BMI) of 30 ?/? or more 17. A person who judges that the tester is unsuitable for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WOMAC pain score | — |
Secondary
| Measure | Time frame |
|---|---|
| 0, 45, 90, 135, 180?;Change of joint space width;Change of WOMAC pain score;Change of joint stiffness, physical function, total score in WOMAC;Change of patient global assessment;Change of ESR, hs-CRP;Clinical laboratory test(blood) and vital sign(body temperature, pulse, blood pressure);Adverse events | — |
Countries
Korea, Republic of
Contacts
Public ContactSang Hyun Lee
Pusan National University Korean Medicine Hospital
Outcome results
None listed