NCT02231138Unknown4 期
Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease：a Multicentre Open Study
Chinese PLA General Hospital78 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,600
- 试验地点
- 78
- 主要终点
- Change in 24-h proteinuria from baseline after treatment
研究概览
简要总结
Huangkui Capsule is a single medicament of traditional Chinese medicine consists of Abelmoschus manihot and has been widely used to treat kidney disease. The purpose of this study is to evaluate the safety and efficacy of Abelmoschus manihot for treating chronic kidney disease in large scale samples with long time take.
详细描述
The test has not been completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosed as non-ESRD chronic kidney disease (stage I-IV)
- •Blood pressure of ≤140/90mmHg
- •Obtaining the signed informed consent from patients
排除标准
- •Be allergic to Huangkui Capsule
- •Combined with severe primary diseases of heart, brain, liver and hematopoietic system and so on, or other serious diseases which can affect the patient's life
- •Lactation, pregnancy or plans pregnancy during the study period
- •Participating in another clinical study in the same period
研究组 & 干预措施
Abelmoschus manihot (AM)
Experimental
- age above 12 years old (including 12)：huangkui capsule are given orally at 2.5 g three times per day
- age between 6-12 years old(including 6):huangkui capsule are given orally at 1.5 g three times per day
- age under 6 years old：huangkui capsule are given orally at 1.0 g three times per day
干预措施: Abelmoschus manihot (AM) (Drug)
结局指标
主要结局
Change in 24-h proteinuria from baseline after treatment
时间窗: Baseline(week 0), week 12, week 24
次要结局
- change in the serum creatinine level from baseline after treatment(Baseline(week 0), week 12, week 24)
- change in the estimated glomerular filtration rate (eGFR) from baseline after treatment(Baseline(week 0), week 12, week 24)
研究者
Xiangmei Chen
professsor
Chinese PLA General Hospital
研究点 (78)
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