Clinical Trial on the Articular Pain of Diagnosed Patients of Arthrosis

Osteoarthritis Clinical Trial

— FISMEH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03525249
• Other study ID #: UCAM-CFE-0002
• Status: Completed
• Phase: N/A
• Start date: March 20, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: October 2019
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Osteoarthritis

Intervention

Dietary Supplement:
• nutraceutical
Subjects will consume a capsule for eight weeks

Locations

Country	Name	City	State
Spain	Catholic University of Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	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.