Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-03 @ 5:28 PM
Study NCT ID:
NCT06506656
Status:
RECRUITING
Last Update Posted:
2024-07-18
First Post:
2024-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyaluronic Acid and Adelmidrol (Hyadrol®) in Patients With Degenerative Joint Disease
Sponsor:
University of Roma La Sapienza
Organization:
Study Overview
Official Title:
Effect of an Intra-articular Treatment With a Combination of Hyaluronic Acid and Adelmidrol (Hyadrol®) on Pain, Joint Stiffness and Functional Limitation in Patients With Degenerative Joint Disease
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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).
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: