None listed
Conditions
Interventions
Dietary Supplement : Test group: once a day, intake 1 capsule once (eggshell membrane extract (NEM® 500mg/1day)
Control group: once a day, intake 1 tablet once (dextrin)
Sponsors
ARI BnC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adults between the ages of 40 and 75 - Subjects with knee KL (Kellgren-Lawrence) grade ?-? - 30 ~ 100mm factor when measuring VAS - Subjects with a BMI (Body Mass Index) of 18.5 kg/m2 or more and less than 30 kg - Subjects who complained of knee discomfort related to exercise or physical activity at any time during the 2 weeks prior to screening - Subjects who voluntarily decides to participate after hearing a detailed explanation of this study and fully understands it and agrees in writing to abide by the precautions
Exclusion criteria
Exclusion criteria: - Subjects diagnosed with inflammatory joint disorder according to the American College of Rheumatology (ACR) - Subjects with moderate or severe synovitis (Kellgren-Lawrence grade III or higher) - Subjects with meniscus rupture - Subjects suffering from diseases of the kidney, liver, respiratory system, gastrointestinal tract, cardiovascular system, endocrine system, or nervous system - Subjects with a history of knee or hip replacement surgery - Pregnant women, those preparing for pregnancy / lactating women - Glucosamine sulfate, chondroitin sulfate, intra-articular hyaluronate or - Subjects who have a history of using systemic or intra-articular glucocorticoids - Subjects who has a history of taking anti-inflammatory drugs, boswellia, curcumin, omega-3 fatty acids, or collagen supplements within 30 days or has used them chronically - alcoholic - Subjects with hyperuricemia and suspected gout - Subjects with allergies/side effects to the test substance - Subjects who have participated in other clinical trials within the last 3 months - Subjects who took painkillers or cold medicine within 1 week of the visit - Uncontrolled diabetes (HbA1C >7.0%) - If you have hip or back pain that interferes with the gait or exercise tests used throughout the study - Subjects who has a history of clinically significant hypersensitivity reaction or who has experience or possibility of hypersensitivity reaction to raw materials (egg shell, egg) for human application test - Subjects who are judged unsuitable for participation in human application tests by the test director - Subjects with mental illness such as identity fever, drug addiction, and those undergoing treatment for depression - Subjects who have a history of treatment for alcoholism or drug abuse - Subjects with AST or ALT more than 3 times the upper limit of normal - Subjects whose serum creatinine is more than twice the upper limit of normal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (WOMAC: Western Ontario and McMaster Universities Osteoarthritis) | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS: Visual analogue scale, WHOZOL-BREF, inflammatory markers(hs-CRP, ESR, TNF-a, IL-1ß), cartilage markers(COMP, MMP-2, (u)CTX-?), Change in knee gap ;Clinical pathology test (blood, urine test) | — |
Countries
Korea, Republic of
Contacts
Public Contacthan joo Lee
ARI BnC
Outcome results
None listed