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

NCT04607759 | Completed

• 1 other identifier: UCAMCFE-00017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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.

• 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

• Functional test

  Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.

• Muscle function

  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

  Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.

Study Arms (2)

Experimental group (cucumber)

EXPERIMENTAL

Consumption for 90 days of cucumber extract (20mg/day) Two capsules a day orally for 90 days.

Dietary Supplement: nutraceutical

control group Placebo (sucrose)

PLACEBO COMPARATOR

Two capsules a day orally for 90 days.

Dietary Supplement: nutraceutical

Interventions

nutraceutical DIETARY_SUPPLEMENT

Subjects will consume two capsules for eight weeks

Experimental group (cucumber); control group Placebo (sucrose)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 29, 2020
• Study Start: January 11, 2021
• Primary Completion: July 31, 2021
• Study Completion: September 1, 2021
• Last Updated: September 17, 2021

Record last verified: 2020-10

Locations

ES (1)