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

• ClinicalTrials.gov Identifier: NCT03525249
• Recruitment Status: Completed
• First Posted: May 15, 2018
• Last Update Posted: October 18, 2019
• Sponsor: Universidad Católica San Antonio de Murcia
• Information provided by (Responsible Party): Francisco Javier López Román, Universidad Católica San Antonio de Murcia

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis	Dietary Supplement: nutraceutical	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 87 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: March 20, 2018
• Actual Primary Completion Date: September 30, 2018
• Actual Study Completion Date: September 30, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. quality of life test [ Time Frame: 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.
2. functional test [ Time Frame: 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
3. blood pressure [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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 32.
• Subjects with a known allergy to eggs.
• Pregnant or lactating women.
• Inability to understand informed consent.

Contacts and Locations

Locations

Spain

Catholic University of Murcia

Murcia, Spain, 30107

Sponsors and Collaborators

Universidad Católica San Antonio de Murcia

More Information

• Responsible Party: Francisco Javier López Román, MD. PhD, Universidad Católica San Antonio de Murcia
• ClinicalTrials.gov Identifier: NCT03525249
• Other Study ID Numbers: UCAM-CFE-0002
• First Posted: May 15, 2018
• Last Update Posted: October 18, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases