Efficacy of Proprietary Cherry Juice Blend in Osteoarthritis of the Knee

Phase 4

Completed

• Conditions: Osteoarthritis
• Interventions: Other: proprietary cherry juice blend (food); Other: control juice (kool aid blend)

• Registration Number: NCT00443092
• Lead Sponsor: CherryPharm

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.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-02
• Study First Submitted QC: 2007-03-02
• Study First Posted: 2007-03-05
• Primary Completion: 2010-06
• Study Completion: 2010-12
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-01
• Last Update Posted: 2012-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	proprietary cherry juice blend (food)	proprietary tart cherry juice blend (8 oz., BID)
2	control juice (kool aid blend)	control juice (color matched kool aid blend),(8 oz., BID)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

VA Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States