None listed
Conditions
Interventions
Dietary Supplement : Test group: 600 mg of eggshell membrane powder, for 12 weeks, once a day, take 3 tablets per time orally with water
Placebo group: 0 mg of eggshell membrane powder, for 12 weeks,
Sponsors
Semyung University Oriental Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A person who is diagnosed with idiopathic (primary) knee osteoarthritis according to ACR diagnostic criteria 2) A person who corresponds to Kellgren-Lawrence grade I~II on knee radiographs 3) A person with knee joint Pain VAS on Walking measurement of 30~100 mm on a 100 mm scale 4) A person with a body mass index (BMI) of 18 kg/m² to 29 kg/m² 5) A person who has complained of knee discomfort related to exercise or physical activity at any time during the 2 weeks prior to screening 6) A person who has voluntarily provided written consent to participate in this human application trial
Exclusion criteria
Exclusion criteria: 1) A person has a history of hypersensitivity to natural substances 2) A person diagnosed with inflammatory joint disorders according to ACR diagnostic criteria 3) A person requiring treatment for degenerative arthritis, such as those with knee joint swelling, unbearable pain, or progressive arthritis 4) A person with hip or lower back pain that interferes with walking or exercise tests used throughout the study 5) A person who has undergone surgical procedures or has secondary knee osteoarthritis induced by trauma within 6 months prior to screening 6) A person with arthritis due to similar conditions (e.g., fibromyalgia, anserine bursitis, infectious arthritis, rheumatoid arthritis, ankylosing spondylitis, gout, or pseudogout) 7) A person who has taken steroids (oral or injectable), glucosamine, chondroitin, intra-articular hyaluronate, systemic or intra-articular glucocorticoids, osteoporosis treatments, muscle relaxants, or received any other treatments aimed at improving degenerative arthritis symptoms (e.g., physical therapy, prolotherapy, Korean medicine) within 3 months prior to screening 8) A person who has taken narcotic or non-narcotic anti-inflammatory/analgesic drugs within 1 week prior to screening 9) A person who has consumed health supplements or functional foods aimed at bone/joint health (e.g., boswellia, curcumin, omega-3 fatty acids, collagen supplements) within 1 month prior to screening or chronically 10) A person who has consumed eggshell membrane-related foods within 1 week prior to screening 11) A person who has undergone knee joint replacement surgery or has a meniscus tear in the target knee 12) A person who has undergone orthopedic surgery, including arthroscopy on the target knee, within 6 months prior to screening or is scheduled to during the study period 13) A person with uncontrolled hypertension (SBP > 170 mmHg or DBP > 100 mmHg) 14) A person with uncontrolled diabetes (HbA1c = 9%) 15) A person with a history of clinically significant endocrine or neurological diseases (e.g., stroke), cardiovascular diseases (e.g., ischemic heart disease, heart failure, anticoagulant use, hematologic abnormalities), or respiratory diseases (e.g., chronic obstructive pulmonary disease, pneumonia, infectious lung diseases) within 1 year prior to screening 16) A person with a history of bleeding within 6 months prior to screening or a history of peptic ulcers or inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis) 17) A person with a history of major gastrointestinal surgery (e.g., gastrectomy, gastrointestinal bypass, anastomosis, excluding appendectomy) 18) A person with clinically significant renal impairment (Serum Creatinine = 2.0 mg/dl) or liver dysfunction (ALT or AST more than 2.5 times the upper limit of normal) 19) A person with a history of drug addiction, dementia, alcohol use disorder, mental illness, or who has used narcotic or psychotropic drugs continuously for more than a week within 4 weeks prior to screening 20) A person with a history of malignant tumors within 5 years prior to screening 21) A person with genetic disorders (e.g., hypermobility), collagen gene abnormalities, Paget's disease, ochronosis, acromegaly, hemochromatosis, Wilson's disease, etc. 22) Pregnant or breastfeeding women, or women of childbearing potential not using appropriate contraception 23) A person who has participated in another clinical (human application) trial within 3 months prior to s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (VAS: Visual analogue scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| WOMAC: Western Ontario and McMaster Universities Osteoarthritis index;SF-36: Short Form-36, Cartilage markers(COMP, CTX-II, MMP9), GUG test: Get up and go test, Squats test | — |
Countries
Korea, Republic of
Contacts
Public ContactHong Ryoul Yoon
Semyung University Oriental Medicine Hospital
Outcome results
None listed