Astaxanthin Effects on Osteoarthritis Associated Pain and Inflammatory Indicators
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in PROMIS Numeric Rating Pain Scale
研究概览
简要总结
This study is intended to assess the effects of astaxanthin use on pain, physical function, and inflammation as reflected by Patient-Reported Outcomes Measurement Information System (PROMIS) scores and levels of inflammatory biomarkers in subjects taking astaxanthin. If improvements in pain, function, and/or markers of inflammation could be demonstrated with the use of astaxanthin, this may suggest the potential for astaxanthin to be used in management of knee osteoarthritis (and possibly other forms of osteoarthritis) with less evident toxicity than seen with the presently available standard therapies (e.g. NSAIDS, opioids).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
double-blind
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
- •Age 18 years or older
- •Symptoms of knee pain
- •Radiographic evidence of mild to moderate arthritis
- •Able to provide written consent on their own behalf
排除标准
- •Pregnancy
- •Current tobacco use
- •Current substance abuse (alcohol or drug)
- •Presence of significant cardiovascular, pulmonary, hepatic, or renal disease
- •Prior history of knee trauma or surgery
- •Gout or pseudogout
- •Significant depression or anxiety scores on PHQ-9 and GAD-7, or pre-existing diagnosis of a significant mental health disorder
- •Presence of other chronic pain syndromes such as chronic low back or neck pain, fibromyalgia, or complex regional pain syndrome
- •Presence of systemic inflammatory conditions such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease
- •Symptomatic involvement of multiple other joints with osteoarthritis
- •Known allergy to fish or astaxanthin
- •BMI greater than 35
- •Participation in another clinical trial
结局指标
主要结局
Change in PROMIS Numeric Rating Pain Scale
时间窗: 20 weeks
Pain improvement in subjects is the primary outcome measure. The Patient Reported Outcomes Measurement Information Systems (PROMIS) Pain Intensity Scale 1a tool will be used. This scale ranges from 0-10, with 0 representing no pain and 10 representing the worst pain imaginable.
次要结局
- Change in PROMIS Physical function score(20 weeks)
- Change in C-reactive protein levels(20 weeks)
- Change in Cartilage Oligomeric Matrix Protein levels(20 weeks)
- Change in PROMIS Pain interference score(20 weeks)
- Change in Erythrocyte Sedimentation Rate(20 weeks)
- Change in Interleukin-6 levels(20 weeks)