KCT0008241Completed未知
Human study for improving Joint Health of (NEM?) Randomized, double-blind, control clinical Trials
ARI BnC0 sites100 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 40(Year) to 75(Year) (—)
- Sex
- All
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
- •- 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
Investigators
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