Study on the Therapeutic Effect of TCM Treatment for MDR MN

Study Overview
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Brief Summary
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To evaluate the effectiveness and safety of the Chinese medicine treatment for multiple drug resistance of MN patients with Jianpiyiqi and Huoxuejiedu Recipe.

Detailed Description
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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.

Official Title
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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)

Conditions
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Idiopathic Membranous Nephropathy

Intervention / Treatment
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* Drug: Jianpixiaozhong particles and Wuse Dietotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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） Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>Jianpixiaozhong particles and Wuse Dietotherapy | Drug: Jianpixiaozhong particles and Wuse Dietotherapy<br>* Jianpixiaozhong particles: Three packs once,bid po; Wuse Dietotherapy: one packs once,bid po<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission rate of 24 hours urinary protein quantitative |  | two weeks to three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function, glomerular filtration rate (EPI formula), Plasma albumin |  | two weeks to three months | 
| Blood lipid |  | half a year | 
| Change of TCM Syndrome |  | two weeks to three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idiopathic Membranous Nephropathy, Jianpiyiqi Recipe, Huoxuejiedu Recipe, Effectiveness, Safety