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:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT02843620
Eligibility Criteria:
Inclusion Criteria:
* Adults between 40 and 75 years old.
* Subject who suffers mild joint discomfort (value between 3 and 5 VAS scale for a minimum of 6 months).
* Subject that after reading and understanding the study's protocol has provided written informed consent to participate in the study.
* Subjects willing to keep stable eating and activity patterns during the duration of the study.
* Subjects who use other therapies for joint discomfort, such as exercise, heat / cold, joint protection and physiotherapy / occupational therapy agree to follow the treatments avoiding changes in the frequency or intensity of them and reporting them at baseline and during follow-ups.
* Subjects agree not start any new therapy during the study period.
* Subjects who have lateral or longitudinal knee synovial effusion according to the index OMERACT (Outcome Measures in Rheumatology) .
Exclusion Criteria:
* Active rheumatoid arthritis, diagnosed osteoarthritis or any other inflammatory arthritic condition that researchers consider non appropriate.
* Being pregnant or lactating.
* Be waiting for joint surgery or major surgery in the next 8 months
* Joint injury in the last 4 months in the area osteoarthritis-affected (i.e. meniscal tear)
* Having underwent reconstructive surgery on the cartilage of the affected knee
* Background of peptidic ulcer and other symptomatic/active disorders of the intestinal tract that may interfere with product under evaluation .
* History of congestive heart failure,
* Allergy to chicken or other ingredients in the product
* Anticipated problems with product consumption
* High alcohol consumption (\> 2 drinks per day)
* History of psychiatric disorders that may impede the ability of subjects to give written informed consent
* Failure to comply with washout periods before the start of the study.
* Paracetamol intake 24 hours before randomization
* The subject does not want to stop taking medication in addition to the study medication (for arthritis or other pain) or not to take other types of medication for the treatment of osteoarthritis pain
* Other conditions that, in the opinion of the principal investigator adversely affect the subject's ability to complete the study or its measures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT02843620
Study Brief:
Protocol Section:
NCT02843620