Clinical Trial on the Articular Pain With a Cucumber Supplement in Patients Diagnosed With Arthrosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Dietary Supplement: nutraceutical


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group (cucumber)<br>Consumption for 90 days of cucumber extract (20mg/day) Two capsules a day orally for 90 days. | Dietary Supplement: nutraceutical<br>* Subjects will consume two capsules for eight weeks<br>|
| Placebo Comparator: control group Placebo (sucrose)<br>Two capsules a day orally for 90 days. | Dietary Supplement: nutraceutical<br>* Subjects will consume two capsules for eight weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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). | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. |