Osteoarthritis
Conditions
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.
Interventions
DIETARY_SUPPLEMENTnutraceutical
Subjects will consume a capsule for eight weeks
Sponsors
Universidad Católica San Antonio de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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 32. * Subjects with a known allergy to eggs. * Pregnant or lactating women. * Inability to understand informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain from baseline at 8 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| quality of life test | it will be measured twice, once at baseline or at the end of the study after 8 weeks of use | The quality of life of the subjects will be measured with the WOMAC test. It is a 24-item test that will measure the degree of pain on a scale of: nothing, little, enough, a lot, and a lot) when performing activities in daily life. |
| functional test | Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption. | The balance and mobility of the subjects will be measured with the Timed Up and Go Test |
| blood pressure | Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption. | the arterial pressure will be measured to the subjects |
Countries
Spain
Outcome results
None listed