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Completed

NCT Number: NCT03525249

Clinical Trial 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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Murcia

Murcia, 30107, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutraceutical

Dietary Supplement

Subjects will consume a capsule for eight weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study 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

Acronym: FISMEH

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 15, 2018
Registry last updated
Oct 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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