NCT06506656 Hyaluronic Acid and Adelmidrol (Hyadrol®) in Patients With Degenerative Joint Disease
| NCT ID | NCT06506656 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Roma La Sapienza |
| Condition | Degenerative Joint Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 59 participants |
| Start Date | 2024-07-16 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 59 participants in total. It began in 2024-07-16 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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.
Contact & Investigator
Maria Chiara Vulpiani
PRINCIPAL INVESTIGATOR
University of Roma La Sapienza
Frequently Asked Questions
Who can join the NCT06506656 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Degenerative Joint Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06506656 currently recruiting?
Yes, NCT06506656 is actively recruiting participants. Contact the research team at mariachiara.vulpiani@uniroma1.it for enrollment information.
Where is the NCT06506656 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06506656 clinical trial?
NCT06506656 is sponsored by University of Roma La Sapienza. The principal investigator is Maria Chiara Vulpiani at University of Roma La Sapienza. The trial plans to enroll 59 participants.