Randomized Clinical Trial to Analyze the Efficacy of a Supplement Removed From Cucumber on the Articular Pain of Diagnosed Patients of Arthrosis

Universidad Católica San Antonio de Murcia1 site in 1 country60 target enrollmentJanuary 11, 2021

ConditionsOsteoarthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Universidad Católica San Antonio de Murcia
Enrollment: 60
Locations: 1
Primary Endpoint: Change in Pain from baseline at 8 weeks
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Randomized, controlled, double-blind clinical trial of two parallel branches to analyze the efficacy of a supplement extracted from the cucumber on the joint pain of patients diagnosed with osteoarthritis.

Detailed Description

The subjects that meet the selection criteria will make a total of two visits to the research laboratory and will carry out the pre-established tests in the protocol. Subsequently, a statistical analysis will be carried out with the variables measured in the study to obtain results.

Registry

clinicaltrials.gov

Start Date

January 11, 2021

End Date

September 1, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Universidad Católica San Antonio de Murcia

Responsible Party

Principal Investigator

Francisco Javier López Román

Principal Investigator

Universidad Católica San Antonio de Murcia

Eligibility Criteria

Inclusion Criteria

•Age over 40 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 a baseline score of at least 30 mm on the VAS pain assessment.
•Subjects should not present narcotic drugs or steroidal anti-inflammatory drugs or immunosuppressants in their treatment.

Exclusion Criteria

•Serious or terminal illnesses.
•Subjects currently taking glucosamine, chondroitin sulfate, collagen or hyaluronic infiltrations 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
•Pregnant or lactating women.
•Inability to understand informed consent.

Outcomes

Primary Outcomes

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).

Visual analog scale from 0 to 10. The higher the value, the more pain.

Secondary Outcomes

Liver safety variables(Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.)
Functional test(Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.)
Inflammatory state IL-b(Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.)
Change in concomitant analgesic medication(Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.)
Quality of life test: WOMAC test(it will be measured twice, once at baseline or at the end of the study after 8 weeks of use)
Muscle function(Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.)
Cartilage metabolism(Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.)