Actively Recruiting
Hyaluronic Acid and Adelmidrol (Hyadrol®) in Patients With Degenerative Joint Disease
Led by University of Roma La Sapienza · Updated on 2024-07-18
59
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
Sponsors
U
University of Roma La Sapienza
Lead Sponsor
A
Azienda Ospedaliera "Sant'Andrea"
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 mast cells present in the synovial membranes act as first sensors in pathological situations, degranulating in an uncontrolled manner. Furthermore, in degenerative joint pathologies, there is a marked reduction in the viscoelastic capacity of the synovial fluid associated with a reduction in both the concentration and the average molecular weight of endogenous hyaluronic acid. The association of hyaluronic acid and Adelmidrol (Hyadrol®) could represent an effective treatment for controlling the neuroinflammation process that supports degenerative joint diseases. The objective of the present clinical investigation is to evaluate its safety and efficacy in patients with arthritis of the hip (coxarthrosis) and trapezium-metacarpal joints (rhizoarthrosis).
CONDITIONS
Official Title
Hyaluronic Acid and Adelmidrol (Hyadrol®) in Patients With Degenerative Joint Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 years or older
- Both genders
- Diagnosis of stage II-III coxarthrosis or rhizoarthrosis confirmed by radiological classification
- Pain intensity of 5 or higher on a numeric rating scale
- No use of anti-inflammatory drugs for at least two weeks before enrollment
- Patients able to follow study requirements
- Signed informed consent
You will not qualify if you...
- Under 40 years of age
- Presence of inflammatory systemic diseases like rheumatoid arthritis
- Severe or progressive medical conditions
- Use of NSAIDs within 2 weeks before enrollment
- Use of corticosteroids within 3 months before enrollment
- Intake of chondroprotectors within 6 months before enrollment
- Arthroscopic or intra-articular treatments within 6 months before enrollment
- Cognitive impairment
- Ongoing rehabilitation or physiotherapy
- Allergy or sensitivity to the study treatment
- Pregnant or breastfeeding women
- Patients unable to comply with study requirements
- Declined to give informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Azienda Ospedaliero-Universitaria Sant'Andrea
Roma, Italy
Actively Recruiting
Research Team
M
Maria Chiara Vulpiani
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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