Clinical Trial on the Articular Pain of Diagnosed Patients of Arthrosis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Dietary Supplement: nutraceutical


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comparator Membraflex 500mg<br>experimental product one dose | Dietary Supplement: nutraceutical<br>* Subjects will consume a capsule for eight weeks<br>|
| Experimental: Comparator Membraflex 300mg<br>experimental product two doses | Dietary Supplement: nutraceutical<br>* Subjects will consume a capsule for eight weeks<br>|
| Placebo Comparator: Placebo Comparator<br>placebo product | Dietary Supplement: nutraceutical<br>* Subjects will consume a capsule for eight weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain from baseline at 8 weeks | analog visual scale | The pain will be measured by a scale twice, at the beginning and at the end of the study (after an 8 week consumption). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life test | 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. | it will be measured twice, once at baseline or at the end of the study after 8 weeks of use | 
| functional test | The balance and mobility of the subjects will be measured with the Timed Up and Go Test | Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption. | 
| blood pressure | the arterial pressure will be measured to the subjects | Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption. |