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CompletedNCT03525249FISMEHUpdated Oct 18, 2019

Clinical Trial on the Articular Pain of Diagnosed Patients of Arthrosis

An interventional study of nutraceutical in Osteoarthritis, sponsored by Universidad Católica San Antonio de Murcia. Completed at 1 site in Spain. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-18.

Sponsored by Universidad Católica San Antonio de Murcia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
87
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Osteoarthritis

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03

In context

Osteoarthritis

4,397 studies on the registry are indexed under Osteoarthritis; 581 are open to participants now.

This study's enrollment of 87 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Universidad Católica San Antonio de Murcia is the lead sponsor of 132 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
87 participants (actual)

Study arms

  • Experimental
    Comparator Membraflex 500mg

    experimental product one dose

    Dietary Supplement: nutraceutical

  • Experimental
    Comparator Membraflex 300mg

    experimental product two doses

    Dietary Supplement: nutraceutical

  • Placebo comparator
    Placebo Comparator

    placebo product

    Dietary Supplement: nutraceutical

Interventions

  • Dietary supplementnutraceutical

    Subjects will consume a capsule for eight weeks

06

What researchers measure

Primary outcomes

  1. Change in Pain from baseline at 8 weeks

    analog visual scale

    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).

Secondary outcomes

  1. quality of life test

    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.

    Time frame: it will be measured twice, once at baseline or at the end of the study after 8 weeks of use

  2. functional test

    The balance and mobility of the subjects will be measured with the Timed Up and Go Test

    Time frame: Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.

  3. blood pressure

    the arterial pressure will be measured to the subjects

    Time frame: Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.

07

Study locations

1 site
  • Catholic University of Murcia
    Murcia, 30107, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03525249
Lead sponsor
Universidad Católica San Antonio de Murcia
Responsible party
Francisco Javier López Román (MD. PhD, Universidad Católica San Antonio de Murcia) — Principal investigator
First posted
May 15, 2018
Start date
Mar 20, 2018
Primary completion
Sep 30, 2018
Completion
Sep 30, 2018
Last update
Oct 18, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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