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Study on the Therapeutic Effect of TCM Treatment for MDR MN

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ClinicalTrials.gov Identifier: NCT02610595
Recruitment Status : Unknown
Verified August 2015 by Shanghai University of Traditional Chinese Medicine.
Recruitment status was:  Not yet recruiting
First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
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
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Idiopathic Membranous Nephropathy Drug: Jianpixiaozhong particles and Wuse Dietotherapy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 220 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Remission rate of 24 hours urinary protein quantitative [ Time Frame: two weeks to three months ]

Secondary Outcome Measures :
  1. Renal function, glomerular filtration rate (EPI formula), Plasma albumin [ Time Frame: two weeks to three months ]
  2. Blood lipid [ Time Frame: half a year ]
  3. Change of TCM Syndrome [ Time Frame: two weeks to three months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02610595


Contacts
Contact: Yueyi Deng, MD. +86-021-64385700-3226 dengyueyi@medmail.com.cn
Contact: Wanjia Chen, MS. +86-021-64385700-3222 wdgzkj@sina.com

Locations
China
Department of Nephrology,Longhua Hospital Not yet recruiting
Shanghai, China, 200032
Contact: YueYI Deng, Dr.    64385700 ext 3222    lhkidney@hotmail.com   
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
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

Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02610595     History of Changes
Other Study ID Numbers: ZY3-CCCX-3-2001
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: August 2015

Keywords provided by Shanghai University of Traditional Chinese Medicine:
Idiopathic Membranous Nephropathy
Jianpiyiqi Recipe
Huoxuejiedu Recipe
Effectiveness
Safety

Additional relevant MeSH terms:
Kidney Diseases
Glomerulonephritis, Membranous
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases