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 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-17.
Sponsored by Universidad Católica San Antonio de Murcia · Not applicable, Interventional, and Treatment
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 60 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →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.
Exclusion Criteria:
Consumption for 90 days of cucumber extract (20mg/day) Two capsules a day orally for 90 days.
Dietary Supplement: nutraceutical
Two capsules a day orally for 90 days.
Dietary Supplement: nutraceutical
Subjects will consume two capsules for eight weeks
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.
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.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Universidad Católica San Antonio de Murcia