Study on the Therapeutic Effect of TCM Treatment for MDR MN

Idiopathic Membranous Nephropathy Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02610595
• Other study ID #: ZY3-CCCX-3-2001
• Status: Not yet recruiting
• Phase: N/A
• First received: November 18, 2015
• Last updated: November 19, 2015
• Start date: December 2015
• Est. completion date: December 2016

Study information

• Verified date: August 2015
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Yueyi Deng, MD.
• Phone: +86-021-64385700-3226
• Email: dengyueyi[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the effectiveness and safety of the Chinese medicine treatment for multiple drug resistance of MN patients with Jianpiyiqi and Huoxuejiedu Recipe.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, Membranous
• Idiopathic Membranous Nephropathy
• Kidney Diseases

Intervention

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

Locations

Country	Name	City	State
China	Department of Nephrology,Longhua Hospital	Shanghai

Sponsors (21)

Lead Sponsor

Collaborator

Shanghai University of Traditional Chinese Medicine

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission rate of 24 hours urinary protein quantitative		two weeks to three months	No
Secondary	Renal function, glomerular filtration rate (EPI formula), Plasma albumin		two weeks to three months	No
Secondary	Blood lipid		half a year	No
Secondary	Change of TCM Syndrome		two weeks to three months	No