A Prospective, Multi-center Study of the Chinese Medicine for the Treatment of MDR Membranous Nephropathy in the Traditional Chinese Medicine (a Herbal Formula for Invigorating Spleen and Benefiting qi and Promoting Blood Circulation)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Remission rate of 24 hours urinary protein quantitative
研究概览
简要总结
To evaluate the effectiveness and safety of the Chinese medicine treatment for multiple drug resistance of MN patients with Jianpiyiqi and Huoxuejiedu Recipe.
详细描述
Based on previous research, the investigators hoping to identity the standard treatment program for MDR IMN patients with high treatment difficulty, TCM syndrome of s Pixushuifan. Subsequently, to evaluate the effectiveness and safety of the Chinese medicine treatment for multiple drug resistance of MN patients with Jianpiyiqi and Huoxuejiedu Recipe. With twenty national-grade III hospital of to formed TCM Comprehensive treatment plan and to evaluate the effectiveness and safety of the Chinese medicine treatment for multiple drug resistance of MN patients with Jianpiyiqi and Huoxuejiedu Recipe. Furthermore, search for potential diagnostic predictor in IMN by Proteomics and Metabolomics. The investigators purpose is improve the clinical remission rate of MN, further establish the treatment of TCM in the treatment of MN.
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
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years;
- •Gender, nationality;
- •Pixushuifan syndrome, IMN confirmed by renal biopsy and clinical examination;
- •Treatment invalided by two or more than two kinds of Hormone or immunosuppressive agents ;
- •CKD phase 1-3（eGFR（EPI Formula）≥30ml/min/1.73m2）
排除标准
- •Progressive MN (progressive renal impairment, renal biopsy confirmed Necrotic Vasculitis and Large crescent formation>50%), combined with IgA nephropathy, diabetic nephropathy and other renal diseases;
- •Anti-nuclear antibodies, double stranded DNA, ANCA or other indicators of immune disorders;
- •Active hepatitis B and liver function test sustained abnormal;
- •Patients with malignant tumor or have a history of cancer, HIV infection, history of mental illness, acute central nervous system diseases, severe gastrointestinal diseases;
- •Merger with other serious disease and dysfunction of the organ;
- •Gravid or lactation woman;
- •Other clinical trials are being studied.
研究组 & 干预措施
experimental group
Jianpixiaozhong particles and Wuse Dietotherapy
干预措施: Jianpixiaozhong particles and Wuse Dietotherapy (Drug)
结局指标
主要结局
Remission rate of 24 hours urinary protein quantitative
时间窗: two weeks to three months
次要结局
- Change of TCM Syndrome(two weeks to three months)
- Renal function, glomerular filtration rate (EPI formula), Plasma albumin(two weeks to three months)
- Blood lipid(half a year)