Human Clinical Trial to Investigate the Effects of High Rosmarinic Acid Spearmint Tea on Markers of Pain, Physical Function and Disease Activity in Osteoarthritis of the Knee
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 4
- 主要终点
- Self-reported ratings of pain and physical function
研究概览
简要总结
The purpose of this study is to investigate the benefits of daily consumption of a high rosmarinic acid spearmint tea, developed by the University of Guelph, on measures of pain, physical function and disease activity in osteoarthritis of the knee.
The investigators hypothesize that a spearmint tea high in rosmarinic acid is efficacious in mitigating the symptoms of osteoarthritis of the knee through its actions in reducing cartilage degradation, oxidative stress and inflammation.
详细描述
Healthy adults with a clinical diagnosis of osteoarthritis of the knee will be recruited and will undergo a brief phone screening interview, followed by a detailed in-person screening process, to determine study eligibility.
Eligible participants will be matched according to sex, baseline pain according to the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score, and duration of osteoarthritis. Participants will then be randomly assigned to receive either the investigative high rosmarinic acid spearmint tea or a comparable placebo mint tea.
During the 4-month treatment period, participants will consume two cups (300 mL in the morning and 300 mL in the evening) of either the high rosmarinic acid spearmint tea (approximately 300 mg rosmarinic acid per day) or the commercial spearmint tea (approximately 20 mg of rosmarinic acid per day) daily.
Data collection will occur at baseline (week 0), mid-treatment (week 8), post-treatment (week 16), and follow-up (week 20). Outcome measures include WOMAC and SF-36 scores, physical function (6-minute walk, stair climb task), inflammatory markers (serum C-reactive protein), and self-reported changes in pain medication use. In a sub-set of consenting participants deemed eligible by the study physician, a synovial fluid sample will be drawn from the knee for the analyses of cartilage degradation biomarkers (GAG, COMP, PGE2, NO) at baseline (week 0) and post-treatment (week 16).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is at least 18 years or older
- •Have been diagnosed by a health care professional with osteoarthritis of the knee
- •Demonstrates a WOMAC pain score greater then 125 at time of study screening
排除标准
- •Has any other systemic or rheumatic arthritis
- •Has completed or is planning to undergo knee replacement surgery
- •Has had a chemical, radiologic, or surgical synovectomy in any large joint within the previous 3 months
- •Has any concomitant inflammatory processes such as infectious or rheumatic disease
- •Has any gastrointestinal ulcers
- •Has any clinically significant, uncontrolled cardiovascular, hepatic, renal, or any other medical condition that may interfere with the study
- •Has any serious medication conditions such as recent (within the previous 6 months) heart attack, stroke, cancer and/or diabetes
- •Has a recent history (within the previous 6 months) of a clinically significant psychiatric disorder other than mild depression
- •Has a known allergy or hypersensitivity to mint or any other food allergies
- •Smokes, drinks alcohol (>14 drinks per week) or participates in recreational drug use
- •Has participated in a clinical trial involving an investigational or marketed drug within the previous 6 months
- •Women who are pregnant or plan to become pregnant during the study period, women who have recently (within the previous 6 months) given birth, women who are currently lactating or have only recently (within the previous 6 months) stopped lactating.
结局指标
主要结局
Self-reported ratings of pain and physical function
时间窗: Four months
Data collection of self-reported ratings of pain and physical function (WOMAC), self-reported ratings of overall physical and mental health (SF-36), and self-reported changes in the use of concomitant pain and inflammation medications (study diary) will occur at baseline (week 0), mid-treatment (week 8), post-treatment (week 16), and follow-up (week 20).
Use of concomitant pain/inflammatory medications for the management of osteoarthritis symptoms
时间窗: Four months
次要结局
- Performance-based measures of physical function(Four months)
- Change in synovial fluid biomarkers of cartilage degradation(Four months)
研究者
Amanda Wright, Ph.D.
Director, HNRU
University of Guelph