Study on the Therapeutic Effect of TCM Treatment for MDR MN

Not Applicable

• Conditions: Idiopathic Membranous Nephropathy
• Interventions: Drug: Jianpixiaozhong particles and Wuse Dietotherapy

• Registration Number: NCT02610595
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

Brief Summary

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

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 Timeline

• Status Verified: 2015-08
• Study First Submitted: 2015-11-18
• Study First Submitted QC: 2015-11-19
• Last Update Submitted: 2015-11-19
• Study First Posted: 2015-11-20
• Last Update Posted: 2015-11-20
• Study Start: 2015-12
• Primary Completion: 2016-06
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental group	Jianpixiaozhong particles and Wuse Dietotherapy	Jianpixiaozhong particles and Wuse Dietotherapy

Primary Outcome Measures

Name	Time	Method
Remission rate of 24 hours urinary protein quantitative	two weeks to three months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Nephrology,Longhua Hospital; 🇨🇳 Shanghai, China