OsteoarthritisCUCARTNCT04607759
Clinical Trial on the Articular Pain With a Cucumber Supplement in Patients Diagnosed With Arthrosis
A study testing nutraceutical in people with Osteoarthritis, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- nutraceutical
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 11 Jan 2021to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial to Analyze the Efficacy of a Supplement Removed From Cucumber on the Articular Pain of Diagnosed Patients of Arthrosis
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- nutraceutical
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutraceuticalDietary supplement
Subjects will consume two capsules for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (cucumber) | Experimental | Consumption for 90 days of cucumber extract (20mg/day)
Two capsules a day orally for 90 days. Receives: Dietary Supplement: nutraceutical |
| control group Placebo (sucrose) | Placebo comparator | Two capsules a day orally for 90 days. Receives: Dietary Supplement: nutraceutical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain from baseline at 8 weeks
Visual analog scale from 0 to 10. The higher the value, the more pain.
Measured: 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 (7)
Change in concomitant analgesic medication
The change in the need for the use of analgesic medications will be evaluated.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start11 Jan 2021
- Primary completion31 Jul 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607759
- Sponsor's protocol ID
- UCAMCFE-00017
- Acronym
- CUCART
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Analyze the Efficacy of a Supplement Removed From Cucumber on the Articular Pain of Diagnosed Patients of Arthrosis
- ClinicalTrials.gov ID
- NCT04607759
- Acronym / sponsor ID
- CUCART / UCAMCFE-00017
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group (cucumber) | Experimental | Dietary Supplement: nutraceuticalConsumption for 90 days of cucumber extract (20mg/day) Two capsules a day orally for 90 days. |
| control group Placebo (sucrose) | Placebo comparator | Dietary Supplement: nutraceuticalTwo capsules a day orally for 90 days. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutraceuticalSubjects will consume two capsules for eight weeks | Dietary supplement | Experimental group (cucumber), control group Placebo (sucrose) |
Primary outcome
Change in Pain from baseline at 8 weeks
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).
Visual analog scale from 0 to 10. The higher the value, the more pain.
7 secondary outcomes
Change in concomitant analgesic medication
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
Time frame: it will be measured twice, once at baseline or at the end of the study after 8 weeks of use
Functional 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
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
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
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
Time frame: Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutraceutical in people with Osteoarthritis, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain from baseline at 8 weeks (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.