Study on the Therapeutic Effect of TCM Treatment for MDR MN

Shanghai University of Traditional Chinese Medicine220 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

220

Conditions

Idiopathic Membranous Nephropathy

Interventions

Jianpixiaozhong particles and Wuse DietotherapyDRUG

Jianpixiaozhong particles: Three packs once,bid po; Wuse Dietotherapy: one packs once,bid po

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18-75 years; 2. Gender, nationality; 3. Pixushuifan syndrome, IMN confirmed by renal biopsy and clinical examination; 4. Treatment invalided by two or more than two kinds of Hormone or immunosuppressive agents ; 5. CKD phase 1-3（eGFR（EPI Formula）≥30ml/min/1.73m2） Exclusion Criteria: 1. 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; 2. Anti-nuclear antibodies, double stranded DNA, ANCA or other indicators of immune disorders; 3. Active hepatitis B and liver function test sustained abnormal; 4. Patients with malignant tumor or have a history of cancer, HIV infection, history of mental illness, acute central nervous system diseases, severe gastrointestinal diseases; 5. Merger with other serious disease and dysfunction of the organ; 6. Gravid or lactation woman; 7. Other clinical trials are being studied.

Locations (1)

Department of Nephrology,Longhua Hospital

Shanghai, China

Outcomes

Primary Outcomes

Remission rate of 24 hours urinary protein quantitative

Time frame: two weeks to three months

Secondary Outcomes

Renal function, glomerular filtration rate (EPI formula), Plasma albumin

Time frame: two weeks to three months

Blood lipid

Time frame: half a year

Change of TCM Syndrome

Time frame: two weeks to three months

Central Contacts

Yueyi Deng, MD.

CONTACT

+86-021-64385700-3226 dengyueyi@medmail.com.cn

Wanjia Chen, MS.

CONTACT

+86-021-64385700-3222 wdgzkj@sina.com

Data from ClinicalTrials.gov

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