A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy of Eleutherococcus Senticosus for Anti-inflammation and Improvement of Erythropoietin Hyporesponsiveness in Subjects Under Renal Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 主要终点
- Erythropoietin (EPO)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, parallel comparison trial to evaluate the efficacy and safety of Eleutherococcus Senticosus taken orally by patients under regular dialysis. Eligible subjects with written consent were randomized into one of the two groups: A. Acanthopanax senticosus (30mg/vial); B. Placebo. After 2-4 weeks of run-in period, the study subjects were asked to take the investigational products orally for 90 days in order to evaluate the effects of oral Eleutherococcus Senticosus liquid on the markers of inflammation, anemia, and safety, and to compare the efficacy among oral Acanthopanax senticosus and placebo.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Under regular dialysis for at least 3 months
- •Hemoglobin (Hb) <11 g/L after regular Erythropoietin (EPO) treatment
- •Subjects with written informed consent form
排除标准
- •Use of steroid or high dose of antiplatelet drug (e.g. Aspirin >300mg) within one month
- •Had surgery, myocardial infarction, or tumor within 12 weeks
- •Currently use of antibiotic treatment for acute infection
- •Pregnant women
- •Reticulocyte>40 x 10^9
- •Anemia (ferritin <100ng/mL and Transferrin Saturation (TSAT) <20%)
- •Urea reduction ratio <65% or single pool Kt/V < 1.0 (hemodialysis patients) or total weekly Kt/V<1.7 (peritoneal dialysis patients)
- •Sudden change of eating habit within one month
- •Expected life less than six months or with unstable medical conditions
- •Known history of allergic reaction to the investigational products
- •With acute diseases and judged by the investigator to be ineligible to participate
- •Received melatonin, androgen therapy or blood transfusion within two months
- •Received any trial medications within 30 days
结局指标
主要结局
Erythropoietin (EPO)
时间窗: baseline and 3 months
value at 3 months minus value at baseline reported
Hemoglobin (Hb)
时间窗: baseline and 3 months
value at 3 months minus value at baseline reported
次要结局
- Hematocrit (Hct)(baseline and 3 months)
- Mean Corpuscular Hemoglobin Concentration (MCHC)(baseline and 3 months)
- Intact Parathyroid Hormone (iPTH)(baseline and 3 months)
- Mean Corpuscular Volume (MCV)(baseline and 3 months)
- Red Blood Cell (RBC)(baseline and 3 months)
- Interleukin 6 (IL-6)(baseline and 3 months)
- Mean Corpuscular Hemoglobin (MCH)(baseline and 3 months)
- Tumor Necrosis Factor - Alpha (TNF-alpha)(baseline and 3 months)
研究者
Nae-Cherng Yang
Associate Professor
Chung Shan Medical University