Status:
RECRUITING
Hyaluronic Acid and Adelmidrol (Hyadrol®) in Patients With Degenerative Joint Disease
Lead Sponsor:
University of Roma La Sapienza
Collaborating Sponsors:
Azienda Ospedaliera "Sant'Andrea"
Conditions:
Degenerative Joint Disease
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
Osteoarthritis is a major cause of chronic musculoskeletal pain. Behind this disorder there is a process of chronic neuroinflammation due to the overactivation of mast cells at the tissue level. The m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT06506656
Start Date
July 16 2024
End Date
July 1 2025
Last Update
July 18 2024
Active Locations (1)
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1
Azienda Ospedaliero-Universitaria Sant'Andrea
Roma, Italy