NCT03525249CompletedNot Applicable
Randomized Clinical Trial to Analyze the Efficacy of a Supplement Removed From the Internal Membrane of the Egg Shell on the Articular Pain of Diagnosed Patients of Arthrosis
Universidad Católica San Antonio de Murcia2 sites in 1 country87 target enrollmentStarted: March 20, 2018Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 87
- Locations
- 2
- Primary Endpoint
- Change in Pain from baseline at 8 weeks
Study Overview
Brief Summary
Randomized, controlled, double-blind clinical trial of three parallel branches to analyze the efficacy of a supplement extracted from the internal membrane of the egg shell on the joint pain of patients diagnosed with osteoarthritis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age over 18 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 an initial score of at least 30 mm in the assessment of pain according to the EVA scale.
- •The subjects should not present in their treatment narcotic drugs or steroidal anti-inflammatory or immunosuppressive drugs.
Exclusion Criteria
- •Serious or terminal illnesses.
- •Subjects who are currently taking glucosamine, chondroitin sulfate, collagen or hyaluronic infiltrates 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
- •Subjects with a known allergy to eggs.
- •Pregnant or lactating women.
- •Inability to understand informed consent.
Arms & Interventions
Comparator Membraflex 300mg
Experimental
experimental product two doses
Intervention: nutraceutical (Dietary Supplement)
Placebo Comparator
Placebo Comparator
placebo product
Intervention: nutraceutical (Dietary Supplement)
Comparator Membraflex 500mg
Experimental
experimental product one dose
Intervention: nutraceutical (Dietary Supplement)
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).
analog visual scale
Secondary Outcomes
- quality of life test(it will be measured twice, once at baseline or at the end of the study after 8 weeks of use)
- functional test(Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.)
- blood pressure(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
MD. PhD
Universidad Católica San Antonio de Murcia
Study Sites (2)
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