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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT06506656
Eligibility Criteria:
Inclusion Criteria:
* age ≥ 40 years;
* both genders;
* diagnosis of stage II-III coxarthrosis or rhizoarthrosis according to radiological classification (Kellgren and Lawrence or modified Eaton-Littler criteria respectively)
* pain intensity ≥ 5 on NRS;
* wash-out for at least two weeks from anti-inflammatory drugs before enrollment;
* compliant patients;
* signed informed consent.
Exclusion Criteria:
* age \< 40 years;
* presence of concomitant inflammatory systemic pathologies (e.g.: rheumatoid arthritis, etc.);
* severe and progressive clinical conditions,
* NSAIDs therapy in the 2 weeks prior to enrollment;
* corticosteroid therapy in the 3 months prior to enrollment;
* chondroprotectors intake in the 6 months prior to enrollment;
* arthroscopic procedures or intra-articular visco-supplementation in the 6 months prior to enrollment;
* presence of cognitive impairment;
* ongoing rehabilitation and/or physiotherapy;
* allergy or hypersensitivity to the study treatment;
* pregnant and/or lactating female subjects;
* not compliant patients;
* denied informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT06506656
Study Brief:
Protocol Section:
NCT06506656