A Double Blind Cross-over Study of the Efficacy of a Proprietary Cherry Juice Blend in Osteoarthritis of the Knee.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Improvement in Western Ontario McMaster Osteoarthritis Index (WOMAC) Scores to be taken at Visits 2-5.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •Inability to discontinue prescription medication for arthritis
- •Unstable medical conditions that would likely prevent the subject from completing the study
- •Food allergies - cherries, apples
结局指标
主要结局
Improvement in Western Ontario McMaster Osteoarthritis Index (WOMAC) Scores to be taken at Visits 2-5.
时间窗: Visit 3 (week 6-7), Visit 5 (week 13-14)
次要结局
- 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))