NCT01845688已完成不适用
Efficacy and Safety Evaluation of QingReMoShen Granule in the Treatment of Idiopathic Membranous Nephropathy : A Randomized Double-Blind Controlled Clinical Study
wanglin1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 24-hour urine protein
研究概览
简要总结
The purpose of this study is to evaluate the clinical safety and efficacy of QingReMoShen Granule to treat idiopathic membranous nephropathy.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men who had a clinic and biopsy-proven idiopathic membranous nephropathy;
- •6.0g≥24 hour urinary protein≥1.0g;
- •serum albumin concentration≥26g/L;
- •Chronic Kidney Disease (CKD)≤3 stage (eGFR>30ml/min/1.73m2 MDRD);
- •Willing to participate in the trial and signed an informed consent.
排除标准
- •Secondary membranous nephropathy;
- •Patients with one of the following circumstances- malignant tumors or malignancy, HIV infection, a history of mental illness, any serious systemic infection, serious gastrointestinal diseases, circulating hepatitis B surface antigens positive or persistent abnormal serum transaminase, abnormal glucose metabolism or diabetes mellitus;
- •Pregnant and lactating women;
- •Undergoing other clinical trials.
研究组 & 干预措施
Losartan Tablets & QingReMoShen Granule
Experimental
Losartan Tablets: 50mg, qd, po. QingReMoShen Granule: 12g, tid, po.
干预措施: Losartan Tablets & QingReMoShen Granule (Drug)
Losartan Tablets & Placebo Granule
Placebo Comparator
Losartan Tablets: 50mg, qd, po. Placebo Granule: 12g, tid, po.
干预措施: Losartan Tablets & Placebo Granule (Drug)
结局指标
主要结局
24-hour urine protein
时间窗: At the 24thweek
次要结局
- serum albumin concentration(At the 24thweek)
- eGFR(At the 24thweek)
- Alanine transaminase(At the 24thweek)
研究者
wanglin
Deputy director of Physicians
Shanghai University of Traditional Chinese Medicine
研究点 (1)
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