Clinical Trial on the Articular Pain of Diagnosed Patients of Arthrosis (FISMEH)

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

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 Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Dietary supplement: nutraceutical

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Comparator Membraflex 500mg; experimental product one dose	Dietary supplement: nutraceutical; Subjects will consume a capsule for eight weeks
Experimental: Comparator Membraflex 300mg; experimental product two doses	Dietary supplement: nutraceutical; Subjects will consume a capsule for eight weeks
Placebo Comparator: Placebo Comparator; placebo product	Dietary supplement: nutraceutical; Subjects will consume a capsule for eight weeks

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2018
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: March 9, 2018
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (Actual): May 15, 2018

Study Record Updates

• Last Update Posted (Actual): October 18, 2019
• Last Update Submitted That Met QC Criteria: October 17, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: UCAM-CFE-0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No