NCT02800629Unknown3 期
Blocking Extracellular Galectin-3 in Patients With Osteoarthritis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- WOMAC-Knee
研究概览
简要总结
The proposed study is a pilot, double-blind, randomized clinical trial comparing galectin-3 inhibition with MCP to placebo for the treatment of knee osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Knee pain in at least one knee for more than half the days in the month prior to screening
- •X-rays showing evidence of knee osteoarthritis by Kellgren and Lawrence Score two or three, with definite osteophytes and possible or definite joint space narrowing, consistent with mild to moderate knee osteoarthritis. If both knees are affected, patients would choose the more severe knee for outcomes assessments.
- •Willingness to maintain stable analgesic regimen throughout the study period
排除标准
- •Diagnosis of fibromyalgia
- •Presence of an underlying inflammatory disease in the affected knee, including Rheumatoid Arthritis, Psoriatic Arthritis, Gout, Pseudogout, or other inflammatory disease.
- •Patients who cannot give consent will be excluded, as will patients who cannot speak, read and understand English, as we will not have translated documents, consent forms, and surveys for them.
- •While this supplement is considered very safe and low risk, patients with underlying significant cytopenia (white blood cell count less than 4.0, hemoglobin less than 10, or platelets less than 100), or with impaired renal function (glomerular filtration rate less than 60) or elevated liver enzymes will be excluded as well.
研究组 & 干预措施
Intervention
Active Comparator
Patients will be given Modified Citrus Pectin twice daily for 12 weeks, and have their change in knee pain as measured by survey instruments assessed
干预措施: Modified Citrus Pectin (Dietary Supplement)
Control
Placebo Comparator
Patients will be given placebo twice daily for 12 weeks, and have their change in knee pain as measured by survey instruments assessed
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
WOMAC-Knee
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
Mark C Fisher
Instructor, HMS
Massachusetts General Hospital
研究点 (2)
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