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

NCT ID: NCT04607759

Last Updated: 2021-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-11

Study Completion Date

2021-09-01

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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental group (cucumber)

Consumption for 90 days of cucumber extract (20mg/day)

Two capsules a day orally for 90 days.

Group Type EXPERIMENTAL

nutraceutical

Intervention Type DIETARY_SUPPLEMENT

Subjects will consume two capsules for eight weeks

control group Placebo (sucrose)

Two capsules a day orally for 90 days.

Group Type PLACEBO_COMPARATOR

nutraceutical

Intervention Type DIETARY_SUPPLEMENT

Subjects will consume two capsules for eight weeks

Interventions

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nutraceutical

Subjects will consume two capsules for eight weeks

Intervention Type DIETARY_SUPPLEMENT

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role lead

Responsible Party

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Francisco Javier López Román

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Catholic University of Murcia

Murcia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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UCAMCFE-00017

Identifier Type: -

Identifier Source: org_study_id

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