NCT04607759CompletedNot Applicable
Randomized Clinical Trial to Analyze the Efficacy of a Supplement Removed From Cucumber on the Articular Pain of Diagnosed Patients of Arthrosis
Universidad Católica San Antonio de Murcia2 sites in 1 country60 target enrollmentStarted: January 11, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Change in Pain from baseline at 8 weeks
Study Overview
Brief Summary
Randomized, controlled, double-blind clinical trial of two parallel branches to analyze the efficacy of a supplement extracted from the cucumber on the joint pain of patients diagnosed with osteoarthritis.
Detailed Description
The subjects that meet the selection criteria will make a total of two visits to the research laboratory and will carry out the pre-established tests in the protocol. Subsequently, a statistical analysis will be carried out with the variables measured in the study to obtain results.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age over 40 years.
- •Subjects diagnosed with osteoarthritis with functional grades I-III according to the modified criteria of the American College of Rheumatology.
- •Subjects must have persistent knee pain associated with osteoarthritis with a baseline score of at least 30 mm on the VAS pain assessment.
- •Subjects should not present narcotic drugs or steroidal anti-inflammatory drugs or immunosuppressants in their treatment.
Exclusion Criteria
- •Serious or terminal illnesses.
- •Subjects currently taking glucosamine, chondroitin sulfate, collagen or hyaluronic infiltrations or any supplement indicated for joint health.
- •Subjects with chronic inflammatory diseases that affect the musculoskeletal system (rheumatoid arthritis, gout, pseudo-gout, Paget's disease, chronic pain syndrome, etc.).
- •Subjects with a body mass index above
- •Pregnant or lactating women.
- •Inability to understand informed consent.
Outcomes
Primary Outcomes
Change in Pain from baseline at 8 weeks
Time Frame: The pain will be measured by a scale twice, at the beginning and at the end of the study (after an 8 week consumption).
Visual analog scale from 0 to 10. The higher the value, the more pain.
Secondary Outcomes
- Liver safety variables(Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.)
- Functional test(Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.)
- Inflammatory state IL-b(Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.)
- Change in concomitant analgesic medication(Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.)
- Quality of life test: WOMAC test(it will be measured twice, once at baseline or at the end of the study after 8 weeks of use)
- Muscle function(Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.)
- Cartilage metabolism(Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.)
Investigators
Francisco Javier López Román
Principal Investigator
Universidad Católica San Antonio de Murcia
Study Sites (2)
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