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Completed

NCT Number: NCT04607759

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

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Murcia

Murcia, 30107, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutraceutical

Dietary Supplement

Subjects will consume two capsules for eight weeks

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    The change in the need for the use of analgesic medications will be evaluated.

  2. 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

    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.

  3. 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.

    The balance and mobility of the subjects will be measured with the Timed Up and Go Test

  4. 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.

    Isokinetic dynamometry.

  5. 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.

    It is a blood test that measures cartilage degradation

  6. 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.

    It is a blood test that measures cartilage degradation

  7. 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.

    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)

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

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

Acronym: CUCART

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 29, 2020
Registry last updated
Sep 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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