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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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02610595
Enrollment
220
Registered
2015-11-20
Start date
2015-12-31
Completion date
2016-12-31
Last updated
2015-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Membranous Nephropathy

Keywords

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

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.

Interventions

DRUGJianpixiaozhong particles and Wuse Dietotherapy

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

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Remission rate of 24 hours urinary protein quantitativetwo weeks to three months

Secondary

MeasureTime frame
Renal function, glomerular filtration rate (EPI formula), Plasma albumintwo weeks to three months
Blood lipidhalf a year
Change of TCM Syndrometwo weeks to three months

Countries

China

Contacts

Primary ContactYueyi Deng, MD.
dengyueyi@medmail.com.cn+86-021-64385700-3226
Backup ContactWanjia Chen, MS.
wdgzkj@sina.com+86-021-64385700-3222

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026