Study on the Therapeutic Effect of TCM Treatment for MDR MN

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)

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

Study Overview

• Status: Unknown
• Conditions: Idiopathic Membranous Nephropathy
• Intervention / Treatment: Drug: Jianpixiaozhong particles and Wuse Dietotherapy

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 Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yueyi Deng, MD.; Phone Number: +86-021-64385700-3226; Email: dengyueyi@medmail.com.cn
• Study Contact Backup: Name: Wanjia Chen, MS.; Phone Number: +86-021-64385700-3222; Email: wdgzkj@sina.com

Study Locations

• China
  • Shanghai, China, 200032
    • Department of Nephrology,Longhua Hospital
    • Contact: YueYI Deng, Dr.; Phone Number: 3222 64385700; Email: lhkidney@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborators: Changhai Hospital; Fudan University; RenJi Hospital; Huashan Hospital; Tongji Hospital; Guang'anmen Hospital of China Academy of Chinese Medical Sciences; Ruijin Hospital; Chinese Academy of Sciences; Zhujiang Hospital; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Nanjing University of Traditional Chinese Medicine; Xinqiao Hospital of Chongqing; Shanghai Changzheng Hospital; ShuGuang Hospital; Shanghai Yueyang Integrated Medicine Hospital; Shanghai 6th People's Hospital; Shanghai Minhang Central Hospital; Guangxi Traditional Chinese Medical University; The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine; Shanghai Putuo District Center Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: November 18, 2015
• First Submitted That Met QC Criteria: November 19, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Estimate): November 20, 2015
• Last Update Submitted That Met QC Criteria: November 19, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Safety; Effectiveness; Idiopathic Membranous Nephropathy; Jianpiyiqi Recipe; Huoxuejiedu Recipe
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Kidney Diseases; Glomerulonephritis, Membranous
• Other Study ID Numbers: ZY3-CCCX-3-2001