Efficacy of Proprietary Cherry Juice Blend in Osteoarthritis of the Knee

CherryPharm

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis

Treatments: Other: proprietary cherry juice blend (food); Other: control juice (kool aid blend)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00443092

CP100M

VA MIRB ID # 00981

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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59 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

proprietary tart cherry juice blend (8 oz., BID)

Treatment:

Other: proprietary cherry juice blend (food)

2

Placebo Comparator group

Description:

control juice (color matched kool aid blend),(8 oz., BID)

Treatment:

Other: control juice (kool aid blend)