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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 21, 2014