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

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

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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