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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group (cucumber) | Experimental | Consumption for 90 days of cucumber extract (20mg/day) Two capsules a day orally for 90 days. |
|
| control group Placebo (sucrose) | Placebo Comparator | Two capsules a day orally for 90 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nutraceutical | Dietary Supplement | Subjects will consume two capsules for eight weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain from baseline at 8 weeks | Visual analog scale from 0 to 10. The higher the value, the more pain. | The pain will be measured by a scale twice, at the beginning and at the end of the study (after an 8 week consumption). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in concomitant analgesic medication | The change in the need for the use of analgesic medications will be evaluated. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of Murcia | Murcia | 30107 | Spain |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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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. |
| 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 | 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. | 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 | 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 | 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) | Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption. |