Evaluation of Curcumin's Effect on Inflammation in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 主要终点
- Mean Interlukin-6 Levels
研究概览
简要总结
Programmed ingestion of turmeric has no adverse effects and reduces plasma level of hs-CRP, IL-6 and TNF-α accompanying with increases albumin levels in hemodialysis patients. Turmeric can be considered as an effective anti-inflammatory supplement in hemodialysis patients.
详细描述
Hemodialysis patients over 18 years were recruited after fulfilling the inclusion criteria.Seventy-one hemodialysis patients were randomized into two groups: the trial group (n =35 ) and the controls (n =36 ); a randomization numeric table was used for allocation sequence . Trial group received turmeric and control group received placebo for 12 weeks. Biochemical determinations included levels of serum albumin (Alb), potassium (K) ,blood urea nitrogen (BUN), serum creatinine (Cr), IL-6 level, TNF- α , and liver function tests and hs-CRP at the start and end of the study were measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, 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
- •Males or females undergoing maintenance hemodyalisis,
- •Age ≥18 year
- •Clinically stable and receiving adequate hemodialysis defined by a single pool Kt/V≥1.20 or no less than 3 dialysis sessions per week with a total dialysis time ≥12 hour per week for at least 3 month before enrollment,
- •Diabetic patients must be willing to commence insulin therapy if deemed necessary for plasma glucose control.
排除标准
- •Active malignant disease (defined as less than 5 year since receiving a diagnosis of being malignancy-free)
- •Critical illness as defined by the need for respiratory or circulatory support (in an intensive care unit)
- •Active vasculitis
- •Severe congestive heart failure (New York Heart Association class IV)
- •Severe chronic systemic infectious or inflammatory disease
- •Liver disease (defined as serum alanine aminotransferase or aspartate aminotransferase levels greater than three times the upper limit of normal)
- •Known or suspected allergy to trial product(s) or related products
- •Treatment with immunosuppressive agents or receipt of any investigational drug within one month preceding screening
- •Recent or current use of anti-inflammatory corticosteroids agents
- •A scheduled renal transplantation within the trial period
研究组 & 干预措施
intervention
the trial group (n =35 )
干预措施: Curcumin Pill (Drug)
placebo
control group
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Interlukin-6 Levels
时间窗: one year
blood even
次要结局
未报告次要终点
研究者
nooshin dalili
Assistant Professor of SBMU
Shahid Beheshti University of Medical Sciences