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Efficacy of Proprietary Cherry Juice Blend in Osteoarthritis of the Knee - NCT00443092-19104(Clinical Trial 164501)



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City:  Philadelphia
State:  
PA
Zip Code: 19104
Conditions: Osteoarthritis
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.
Study summary: 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.
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
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Data Source: ClinicalTrials.gov
Date Processed: August 3, 2010
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