Clinical trial NCT00443092: Efficacy of Proprietary Cherry Juice Blend in Osteoarthritis of the Knee
Official title: A Double Blind Cross-over Study of the Efficacy of a Proprietary Cherry Juice Blend in Osteoarthritis of the Knee.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: osteoarthritis
gout
pain
uric acid
tart cherry
alternative medicine
knees
Lead sponsor: CherryPharm
Sponsor class: INDUSTRY
First posted: 2007-03-05
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 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

Primary outcomes:
measure: Improvement in Western Ontario McMaster Osteoarthritis Index (WOMAC) Scores to be taken at Visits 2-5.
timeFrame: Visit 3 (week 6-7), Visit 5 (week 13-14)
Secondary outcomes:
measure: 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).
timeFrame: Visit 3 (week 6-7), Visit 5 (week 13-14)
measure: Determine if there is a decrease in serum uric acid levels. (Visits 1,3,5)
timeFrame: Visit 3 (week 6-7), Visit 5 (week 13-14)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: VA Medical Center
state: Pennsylvania
Study officials:
affiliation: VA Medical Center, Philadelphia & University of Pennsylvania
name: H. R Schumacher, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: BLAU LW. Cherry diet control for gout and arthritis. Tex Rep Biol Med. 1950;8(3):309-11. No abstract available.
citation: 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. doi: 10.1136/bjsm.2005.025429. Epub 2006 Jun 21.
citation: 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. doi: 10.1078/0944-7113-00053.
citation: 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. doi: 10.1080/03009740600704155.
citation: 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. doi: 10.1093/jn/133.6.1826.
citation: 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. doi: 10.1136/ard.2003.020313. Epub 2004 Apr 13.
citation: 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(5):902-9. doi: 10.2106/00004623-200405000-00003.
citation: 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. doi: 10.1002/art.1780290816.