Efficacy of Proprietary Cherry Juice Blend in Osteoarthritis of the Knee - Full Text View

Sponsor:	CherryPharm
Information provided by:	CherryPharm
ClinicalTrials.gov Identifier:	NCT00443092

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 IV

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
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:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

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 ]

Estimated Enrollment:	50
Study Start Date:	March 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental proprietary cherry juice blend	Other: proprietary cherry juice blend (food) 2 bottles per day for 6 weeks, 1 in the morning and 1 in the evening
2: Placebo Comparator control juice (kool aid blend)	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 79 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

Contacts

Contact: Jan Dinnella

215-823-4240

jdinnell@mail.med.upenn.edu

Locations

United States, Pennsylvania
VA Medical Center	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: H. R. Schumacher, M.D.

Sponsors and Collaborators

CherryPharm

Investigators

Principal Investigator:

H. R Schumacher, M.D.

VA Medical Center, Philadelphia & University of Pennsylvania

More Information

Publications:

BLAU LW. Cherry diet control for gout and arthritis. Tex Rep Biol Med. 1950;8(3):309-11. No abstract available.

Connolly DA, McHugh MP, Padilla-Zakour OI, Carlson L, Sayers SP. Efficacy of a tart cherry juice blend in preventing the symptoms of muscle damage. Br J Sports Med. 2006 Aug;40(8):679-83; discussion 683. Epub 2006 Jun 21.

Seeram NP, Momin RA, Nair MG, Bourquin LD. Cyclooxygenase inhibitory and antioxidant cyanidin glycosides in cherries and berries. Phytomedicine. 2001 Sep;8(5):362-9.

He YH, Zhou J, Wang YS, Xiao C, Tong Y, Tang JC, Chan AS, Lu AP. Anti-inflammatory and anti-oxidative effects of cherries on Freund's adjuvant-induced arthritis in rats. Scand J Rheumatol. 2006 Sep-Oct;35(5):356-8.

Jacob RA, Spinozzi GM, Simon VA, Kelley DS, Prior RL, Hess-Pierce B, Kader AA. Consumption of cherries lowers plasma urate in healthy women. J Nutr. 2003 Jun;133(6):1826-9.

Pincus T, Koch G, Lei H, Mangal B, Sokka T, Moskowitz R, Wolfe F, Gibofsky A, Simon L, Zlotnick S, Fort JG. Patient Preference for Placebo, Acetaminophen (paracetamol) or Celecoxib Efficacy Studies (PACES): two randomised, double blind, placebo controlled, crossover clinical trials in patients with knee or hip osteoarthritis. Ann Rheum Dis. 2004 Aug;63(8):931-9. Epub 2004 Apr 13.

Johanson NA, Liang MH, Daltroy L, Rudicel S, Richmond J. American Academy of Orthopaedic Surgeons lower limb outcomes assessment instruments. Reliability, validity, and sensitivity to change. J Bone Joint Surg Am. 2004 May;86-A(5):902-9.

Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49.

Responsible Party:	Cherry Pharm ( John Davey, )
Study ID Numbers:	CP100M, VA MIRB ID # 00981
Study First Received:	March 2, 2007
Last Updated:	April 30, 2008
ClinicalTrials.gov Identifier:	NCT00443092 History of Changes
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, Knee
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 09, 2009