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

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Dietary Supplement: nutraceutical

• Registration Number: NCT04607759
• Lead Sponsor: Universidad Católica San Antonio de Murcia

Brief 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.

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 Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-23
• Study First Posted: 2020-10-29
• Study Start: 2021-01-11
• Primary Completion: 2021-07-31
• Study Completion: 2021-09-01
• Last Update Submitted: 2021-09-16
• Last Update Posted: 2021-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group (cucumber)	nutraceutical	Consumption for 90 days of cucumber extract (20mg/day) Two capsules a day orally for 90 days.
control group Placebo (sucrose)	nutraceutical	Two capsules a day orally for 90 days.

Primary Outcome Measures

Name	Time	Method
Change in Pain from baseline at 8 weeks	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 Outcome Measures

Name	Time	Method
Liver safety variables	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)
Functional test	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
Inflammatory state IL-b	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
Change in concomitant analgesic medication	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.
Quality of life test: WOMAC test	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.
Muscle function	Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.	Isokinetic dynamometry.
Cartilage metabolism	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

Trial Locations

Locations (1)

Catholic University of Murcia; 🇪🇸 Murcia, Spain