Back to results

Study on the Therapeutic Effect of TCM Treatment for MDR MN

Primary Purpose

Idiopathic Membranous Nephropathy

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Jianpixiaozhong particles and Wuse Dietotherapy

About this trial

This is an interventional treatment trial for Idiopathic Membranous Nephropathy focused on measuring Idiopathic Membranous Nephropathy, Jianpiyiqi Recipe, Huoxuejiedu Recipe, Effectiveness, Safety

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Nephrology,Longhua Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

experimental group

Arm Description

Jianpixiaozhong particles and Wuse Dietotherapy

Outcomes

Primary Outcome Measures

Remission rate of 24 hours urinary protein quantitative

Secondary Outcome Measures

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

Blood lipid

Change of TCM Syndrome

Full Information

NCT ID

NCT02610595

First Posted

November 18, 2015

Last Updated

November 19, 2015

Sponsor

Shanghai University of Traditional Chinese Medicine

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02610595

Brief Title

Study on the Therapeutic Effect of TCM Treatment for MDR MN

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Unknown status

Study Start Date

December 2015 (undefined)

Primary Completion Date

June 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai University of Traditional Chinese Medicine

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Membranous Nephropathy

Keywords

Idiopathic Membranous Nephropathy, Jianpiyiqi Recipe, Huoxuejiedu Recipe, Effectiveness, Safety

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

experimental group

Arm Type

Experimental

Arm Description

Jianpixiaozhong particles and Wuse Dietotherapy

Intervention Type

Drug

Intervention Name(s)

Jianpixiaozhong particles and Wuse Dietotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Remission rate of 24 hours urinary protein quantitative

Time Frame

two weeks to three months

Secondary Outcome Measure Information:

Title

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

Time Frame

two weeks to three months

Title

Blood lipid

Time Frame

half a year

Title

Change of TCM Syndrome

Time Frame

two weeks to three months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yueyi Deng, MD.

Phone

+86-021-64385700-3226

dengyueyi@medmail.com.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Wanjia Chen, MS.

Phone

+86-021-64385700-3222

wdgzkj@sina.com

Facility Information:

Facility Name

Department of Nephrology,Longhua Hospital

City

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

YueYI Deng, Dr.

Phone

64385700

Ext

3222

lhkidney@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Study on the Therapeutic Effect of TCM Treatment for MDR MN

We'll reach out to this number within 24 hrs