Study on the Therapeutic Effect of TCM Treatment for MDR MN

NCT ID: NCT02610595

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-12-31

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.

Conditions

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Idiopathic Membranous Nephropathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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experimental group

Jianpixiaozhong particles and Wuse Dietotherapy

Group Type EXPERIMENTAL

Jianpixiaozhong particles and Wuse Dietotherapy

Intervention Type DRUG

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

Interventions

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Jianpixiaozhong particles and Wuse Dietotherapy

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role collaborator

Shanghai 6th People's Hospital

OTHER

Sponsor Role collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role collaborator

Shanghai Putuo District Center Hospital

OTHER

Sponsor Role collaborator

ShuGuang Hospital

OTHER

Sponsor Role collaborator

Shanghai Yueyang Integrated Medicine Hospital

OTHER

Sponsor Role collaborator

Shanghai Changzheng Hospital

OTHER

Sponsor Role collaborator

Shanghai Minhang Central Hospital

OTHER

Sponsor Role collaborator

Zhujiang Hospital

OTHER

Sponsor Role collaborator

Guangxi Traditional Chinese Medical University

OTHER

Sponsor Role collaborator

Huashan Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Xinqiao Hospital of Chongqing

OTHER

Sponsor Role collaborator

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role collaborator

Nanjing University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role collaborator

Chinese Academy of Sciences

OTHER_GOV

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Nephrology,Longhua Hospital

Shanghai, , China

Site Status

Countries

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China

Central Contacts

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Yueyi Deng, MD.

Role: CONTACT

+86-021-64385700-3226

Wanjia Chen, MS.

Role: CONTACT

+86-021-64385700-3222

Facility Contacts

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YueYI Deng, Dr.

Role: primary

64385700 ext. 3222

Other Identifiers

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ZY3-CCCX-3-2001

Identifier Type: -

Identifier Source: org_study_id