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

March 2, 2007
August 1, 2012
March 2007
June 2010   (final data collection date for primary outcome measure)
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 ]
Improvement in Western Ontario McMaster Osteoarthritis Index (WOMAC) Scores to be taken at Visits 2-5.
Complete list of historical versions of study NCT00443092 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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).
  • Determine if there is a decrease in serum uric acid levels. (Visits 1,3,5)
Not Provided
Not Provided
 
Efficacy of Proprietary Cherry Juice Blend in Osteoarthritis of the Knee
A Double Blind Cross-over Study of the Efficacy of a 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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Osteoarthritis
  • Other: proprietary cherry juice blend (food)
    2 bottles per day for 6 weeks, 1 in the morning and 1 in the evening
  • Other: control juice (kool aid blend)
    2 bottles per day for 6 weeks, 1 in the morning and 1 in the evening
  • Experimental: 1
    proprietary tart cherry juice blend (8 oz., BID)
    Intervention: Other: proprietary cherry juice blend (food)
  • Placebo Comparator: 2
    control juice (color matched kool aid blend),(8 oz., BID)
    Intervention: Other: control juice (kool aid blend)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
December 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00443092
CP100M, VA MIRB ID # 00981
No
Brian Ross, Cherry Pharm
CherryPharm
Not Provided
Principal Investigator: H. R Schumacher, M.D. VA Medical Center, Philadelphia & University of Pennsylvania
CherryPharm
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP