Efficacy of Proprietary Cherry Juice Blend in Osteoarthritis of the Knee

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Double Blind Cross-over Study of the Efficacy of a Proprietary Cherry Juice Blend in Osteoarthritis of the Knee.

Conditions
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Osteoarthritis

Intervention / Treatment
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* Other: proprietary cherry juice blend (food)
* Other: control juice (kool aid blend)


Participation Criteria
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Eligibility Criteria
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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: Meets clinical ACR criteria Kellgren score of 2-3 on a Standing Knee x-ray within previous 24 months 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>proprietary tart cherry juice blend (8 oz., BID) | Other: proprietary cherry juice blend (food)<br>* 2 bottles per day for 6 weeks, 1 in the morning and 1 in the evening<br>|
| Placebo Comparator: 2<br>control juice (color matched kool aid blend),(8 oz., BID) | Other: control juice (kool aid blend)<br>* 2 bottles per day for 6 weeks, 1 in the morning and 1 in the evening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Western Ontario McMaster Osteoarthritis Index (WOMAC) Scores to be taken at Visits 2-5. |  | Visit 3 (week 6-7), Visit 5 (week 13-14) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  | Visit 3 (week 6-7), Visit 5 (week 13-14) | 
| Determine if there is a decrease in serum uric acid levels. (Visits 1,3,5) |  | Visit 3 (week 6-7), Visit 5 (week 13-14) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, gout, pain, uric acid, tart cherry, alternative medicine, knees