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 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT04607759
Eligibility Criteria:
Inclusion Criteria:
* Age over 40 years.
* Subjects diagnosed with osteoarthritis with functional grades I-III according to the modified criteria of the American College of Rheumatology.
* Subjects must have persistent knee pain associated with osteoarthritis with a baseline score of at least 30 mm on the VAS pain assessment.
* Subjects should not present narcotic drugs or steroidal anti-inflammatory drugs or immunosuppressants in their treatment.
Exclusion Criteria:
* Serious or terminal illnesses.
* Subjects currently taking glucosamine, chondroitin sulfate, collagen or hyaluronic infiltrations or any supplement indicated for joint health.
* Subjects with chronic inflammatory diseases that affect the musculoskeletal system (rheumatoid arthritis, gout, pseudo-gout, Paget's disease, chronic pain syndrome, etc.).
* Subjects with a body mass index above 32.
* Pregnant or lactating women.
* Inability to understand informed consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT04607759
Study Brief:
Protocol Section:
NCT04607759