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

U

Universidad Católica San Antonio de Murcia

Status

Completed

Conditions

Osteoarthritis

Treatments

Dietary Supplement: nutraceutical

Study type

Interventional

Funder types

Other

Identifiers

NCT03525249
UCAM-CFE-0002

Details and patient eligibility

About

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.

Enrollment

87 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

87 participants in 3 patient groups, including a placebo group

Comparator Membraflex 500mg
Experimental group
Description:
experimental product one dose
Treatment:
Dietary Supplement: nutraceutical
Comparator Membraflex 300mg
Experimental group
Description:
experimental product two doses
Treatment:
Dietary Supplement: nutraceutical
Placebo Comparator
Placebo Comparator group
Description:
placebo product
Treatment:
Dietary Supplement: nutraceutical

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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