Clinical trial NCT04607759: Clinical Trial on the Articular Pain With a Cucumber Supplement in Patients Diagnosed With Arthrosis
Official title: Randomized Clinical Trial to Analyze the Efficacy of a Supplement Removed From Cucumber on the Articular Pain of Diagnosed Patients of Arthrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 32.
* Pregnant or lactating women.
* Inability to understand informed consent.

Primary outcomes:
measure: Change in Pain from baseline at 8 weeks
timeFrame: 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:
measure: Change in concomitant analgesic medication
timeFrame: Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.
measure: Quality of life test: WOMAC test
timeFrame: it will be measured twice, once at baseline or at the end of the study after 8 weeks of use
measure: Functional test
timeFrame: Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.
measure: Muscle function
timeFrame: Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.
measure: Inflammatory state IL-b
timeFrame: Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.
measure: Cartilage metabolism
timeFrame: Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.
measure: Liver safety variables
timeFrame: Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
References: