Clinical Trial on the Articular Pain of Diagnosed Patients of Arthrosis

NCT03525249 | Completed

• 1 other identifier: UCAM-CFE-0002
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

Study Arms (3)

Comparator Membraflex 500mg

EXPERIMENTAL

experimental product one dose

Dietary Supplement: nutraceutical

Comparator Membraflex 300mg

EXPERIMENTAL

experimental product two doses

Dietary Supplement: nutraceutical

Placebo Comparator

PLACEBO COMPARATOR

placebo product

Dietary Supplement: nutraceutical

Interventions

nutraceutical DIETARY_SUPPLEMENT

Subjects will consume a capsule for eight weeks

Comparator Membraflex 300mg; Comparator Membraflex 500mg; Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PhD

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: May 15, 2018
• Study Start: March 20, 2018
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: October 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)