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Completed

NCT Number: NCT00443092

Efficacy of Proprietary Cherry Juice Blend in Osteoarthritis of the Knee

The primary purpose of this research study is to test the ability of a proprietary cherry juice blend to be helpful in the treatment of osteoarthritis (OA) of the knee.

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Key information

About this study

The primary objective is to determine if the proprietary tart cherry juice blend improves the pain and function in persons with knee osteoarthritis. A secondary objective is to ascertain if the blend lowers serum uric acid.

This is a prospective double blind, placebo controlled cross-over study.

The study will be performed in the Philadelphia VA Medical Center 1 South Rheumatology Clinic with patients meeting ACR criteria for Kellgren grade 2-3 knee osteoarthritis and 4-9 pain severity on a VAS. Fifty patients will be studied with each having 5 visits. Subjects will take either the proprietary cherry blend or placebo for 6 weeks and then switch. WOMAC pain and function will be the primary outcome with acetaminophen use, walking time and serum uric acid as secondary outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is capable of giving informed consent.
  • Subject is over 18 years and less than 80 years
  • Subject has mild to moderate osteoarthritis of the knee based on all of the following 3:
  • Meets clinical ACR criteria
  • Kellgren score of 2-3 on a Standing Knee x-ray within previous 24 months
  • VAS pain score of 4-9 at screening visit

Exclusion criteria

  • Rheumatoid arthritis or other systemic inflammatory condition
  • Chronic pain syndrome (fibromyalgia)
  • Corticosteroid medication in last 2 months, either intra-articular or oral
  • Intra-articular injections of hyaluronic acid in last 9 months
  • Pregnant women (weight gain might confound degree of knee pain)
  • Diabetes
  • Inability to discontinue prescription medication for arthritis
  • Unstable medical conditions that would likely prevent the subject from completing the study
  • Food allergies - cherries, apples

Treatment and study plan

proprietary cherry juice blend (food)

Other

2 bottles per day for 6 weeks, 1 in the morning and 1 in the evening

control juice (kool aid blend)

Other

2 bottles per day for 6 weeks, 1 in the morning and 1 in the evening

Primary outcomes

  1. Improvement in Western Ontario McMaster Osteoarthritis Index (WOMAC) Scores to be taken at Visits 2-5.

    Time frame: Visit 3 (week 6-7), Visit 5 (week 13-14)

Secondary outcomes

  1. Determine if there is a decrease in amount of non-prescription pain medication taken and/or improvement in score on a timed walking test (Visits 2,3,4,5).

    Time frame: Visit 3 (week 6-7), Visit 5 (week 13-14)

  2. Determine if there is a decrease in serum uric acid levels. (Visits 1,3,5)

    Time frame: Visit 3 (week 6-7), Visit 5 (week 13-14)

Sponsors and collaborators

Lead sponsor

CherryPharm

Industry

Registry information

Official study title

A Double Blind Cross-over Study of the Efficacy of a Proprietary Cherry Juice Blend in Osteoarthritis of the Knee.

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Mar 5, 2007
Registry last updated
Aug 3, 2012

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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