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)
1 other identifier
interventional
220
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2015
CompletedFirst Posted
Study publicly available on registry
November 20, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedNovember 20, 2015
August 1, 2015
6 months
November 18, 2015
November 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Remission rate of 24 hours urinary protein quantitative
two weeks to three months
Secondary Outcomes (3)
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
Study Arms (1)
experimental group
EXPERIMENTALJianpixiaozhong particles and Wuse Dietotherapy
Interventions
Jianpixiaozhong particles: Three packs once,bid po; Wuse Dietotherapy: one packs once,bid po
Eligibility Criteria
You may qualify if:
- 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）
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai University of Traditional Chinese Medicinelead
- Fudan Universitycollaborator
- Ruijin Hospitalcollaborator
- Shanghai 6th People's Hospitalcollaborator
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicinecollaborator
- Changhai Hospitalcollaborator
- Shanghai Putuo District Center Hospitalcollaborator
- ShuGuang Hospitalcollaborator
- Shanghai Yueyang Integrated Medicine Hospitalcollaborator
- Shanghai Changzheng Hospitalcollaborator
- Shanghai Minhang Central Hospitalcollaborator
- Zhujiang Hospitalcollaborator
- Guangxi Traditional Chinese Medical Universitycollaborator
- Huashan Hospitalcollaborator
- The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicinecollaborator
- Xinqiao Hospital of Chongqingcollaborator
- Guang'anmen Hospital of China Academy of Chinese Medical Sciencescollaborator
- Nanjing University of Traditional Chinese Medicinecollaborator
- Tongji Hospitalcollaborator
- Chinese Academy of Sciencescollaborator
- RenJi Hospitalcollaborator
Study Sites (1)
Department of Nephrology,Longhua Hospital
Shanghai, 200032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2015
First Posted
November 20, 2015
Study Start
December 1, 2015
Primary Completion
June 1, 2016
Study Completion
December 1, 2016
Last Updated
November 20, 2015
Record last verified: 2015-08