Efficacy of Proprietary Cherry Juice Blend in Osteoarthritis of the Knee

This study has been completed.
Sponsor:
Information provided by:
CherryPharm
ClinicalTrials.gov Identifier:
NCT00443092
First received: March 2, 2007
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Other: proprietary cherry juice blend (food)
Other: control juice (kool aid blend)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Double Blind Cross-over Study of the Efficacy of a Proprietary Cherry Juice Blend in Osteoarthritis of the Knee.

Resource links provided by NLM:


Further study details as provided by CherryPharm:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: March 2007
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
proprietary tart cherry juice blend (8 oz., BID)
Other: proprietary cherry juice blend (food)
2 bottles per day for 6 weeks, 1 in the morning and 1 in the evening
Placebo Comparator: 2
control juice (color matched kool aid blend),(8 oz., BID)
Other: control juice (kool aid blend)
2 bottles per day for 6 weeks, 1 in the morning and 1 in the evening

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

    1. Meets clinical ACR criteria
    2. Kellgren score of 2-3 on a Standing Knee x-ray within previous 24 months
    3. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00443092

Locations
United States, Pennsylvania
VA Medical Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
CherryPharm
Investigators
Principal Investigator: H. R Schumacher, M.D. VA Medical Center, Philadelphia & University of Pennsylvania
  More Information

Publications:

Responsible Party: Brian Ross, Cherry Pharm
ClinicalTrials.gov Identifier: NCT00443092     History of Changes
Other Study ID Numbers: CP100M, VA MIRB ID # 00981
Study First Received: March 2, 2007
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by CherryPharm:
osteoarthritis
gout
pain
uric acid
tart cherry
alternative medicine
knees

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014