Clinical Trial on the Articular Pain of Diagnosed Patients of Arthrosis

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Dietary Supplement: nutraceutical

• Registration Number: NCT03525249
• Lead Sponsor: Universidad Católica San Antonio de Murcia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-09
• Study Start: 2018-03-20
• Study First Submitted QC: 2018-05-14
• Study First Posted: 2018-05-15
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-17
• Last Update Posted: 2019-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator	nutraceutical	placebo product
Comparator Membraflex 500mg	nutraceutical	experimental product one dose
Comparator Membraflex 300mg	nutraceutical	experimental product two doses

Primary Outcome Measures

Name	Time	Method
Change in Pain from baseline at 8 weeks	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

Name	Time	Method
quality of life test	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.
functional test	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
blood pressure	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

Trial Locations

Locations (1)

Catholic University of Murcia; 🇪🇸 Murcia, Spain