Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT06535204
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 40 to 75 years, regardless of gender
* Individuals with a Visual Analogue Scale (VAS) score of 3/10 or higher
* Individuals with a Kellgren \& Lawrence grading scale of grade 1 or 2, determined by 'Both Knee Joint AP/LAT' radiographs
* Individuals who have had a washout period of at least 4 weeks for arthritis- related medications or health supplements
* Individuals capable of normal physical activity who have voluntarily provided written informed consent to participate in this study
Exclusion Criteria:
* Individuals with a history of fractures within the past year
* Individuals with osteophytes around the joints, irregular joint surfaces, or subchondral bone cysts, indicating moderate arthritis
* Individuals currently undergoing treatment for a diagnosed thyroid disorder
* Individuals with kidney disease or serum creatinine levels of 1.4 mg/dL or higher
* Individuals with proteinuria of 2+ or higher
* Individuals with liver disease or AST or ALT levels of 100 IU/L or higher
* Individuals with uncontrolled hypertension or heart conditions such as angina or myocardial infarction
* Individuals taking medication for psychiatric disorders, except for intermittent medication for sleep disorders
* Individuals who have taken herbal or medicinal decoctions within the past two months
* Individuals who have received other investigational drugs within the past four weeks
* Individuals who need to continuously take medication that may affect the outcome of the study
* Individuals with a history of gastrointestinal resection surgery (excluding appendectomy)
* Pregnant or breastfeeding women
* Individuals with alcoholism or those who drink more than four times per week regularly
* Individuals with hypersensitivity to the test food or its ingredients
* Individuals who may be uncooperative or deemed incapable of completing the study by the investigator
* Individuals with arthritis due to specific factors other than degeneration, as determined by the principal investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT06535204
Study Brief:
Protocol Section:
NCT06535204