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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Subjects will consume two capsules for eight weeks
Catholic University of Murcia
Murcia, Spain
Change in Pain from baseline at 8 weeks
Visual analog scale from 0 to 10. The higher the value, the more pain.
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).
Change in concomitant analgesic medication
The change in the need for the use of analgesic medications will be evaluated.
Time frame: 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
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: 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
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.
Muscle function
Isokinetic dynamometry.
Time frame: 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
It is a blood test that measures cartilage degradation
Time frame: Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.
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Cartilage metabolism
It is a blood test that measures cartilage degradation
Time frame: Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.
Liver safety variables
It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)
Time frame: Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.