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

Osteoarthritis Clinical Trial

— CUCART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04607759
• Other study ID #: UCAMCFE-00017
• Status: Completed
• Phase: N/A
• Start date: January 11, 2021
• Est. completion date: September 1, 2021

Study information

• Verified date: October 2020
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 1, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Dietary Supplement:
• nutraceutical
Subjects will consume two capsules for eight weeks

Locations

Country	Name	City	State
Spain	Catholic University of Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.