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 Murcia1 site in 1 country87 target enrollmentMarch 20, 2018

ConditionsOsteoarthritis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Universidad Católica San Antonio de Murcia
Enrollment: 87
Locations: 1
Primary Endpoint: Change in Pain from baseline at 8 weeks
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

March 20, 2018

End Date

September 30, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Universidad Católica San Antonio de Murcia

Responsible Party

Principal Investigator

Francisco Javier López Román

MD. PhD

Universidad Católica San Antonio de Murcia

Eligibility Criteria

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.

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.)