NCT03953261终止2 期
Effect of Curcumin on Systemic Lupus Erythematosus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change in SLEDAI
研究概览
简要总结
The purpose of this investigator initiated study is to determine the efficacy of curcumin on disease activity of subjects with systemic lupus erythematous. Curcumin has been found to have anti-inflammatory effects and has been found to improve disease activity in lupus patients. In addition, subjects with rheumatoid arthritis as well as osteoarthritis have also found benefit for their disease activity.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 18 or older
- •Diagnosed with Systemic Lupus Erythematous according to the 2012 Systemic Lupus International Collaborating Clinics Classification Criteria.
- •SLEDAI score of 6 or higher
- •Ability to take oral medication and be willing to adhere to the study drug regimen
排除标准
- •Inability to provide written consent for study participation
- •Use of curcumin supplements within 30 days of enrollment of study
- •Liver function disorders (AST/ALT > 2.5x upper limit of normal)
- •Pregnancy or lactation
- •Known allergic reactions to turmeric
- •Subjects who are admitted for recent hospitalization within past 60 days
- •Treatment with another investigational drug or other intervention within past 60 days
- •Subjects with end stage renal disease on dialysis
- •Subjects who lack the ability to provide consent
研究组 & 干预措施
Curcumin
Experimental
干预措施: Curcumin supplement (Drug)
Placebo
Placebo Comparator
干预措施: Curcumin supplement (Drug)
结局指标
主要结局
Change in SLEDAI
时间窗: 90 days
Number of participants with change in SLEDAI by 2 points by Day 90
次要结局
未报告次要终点
研究者
研究点 (1)
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