Study on the Therapeutic Effect of TCM Treatment for MDR MN

November 19, 2015 updated by: Shanghai University of Traditional Chinese Medicine

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)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Wanjia Chen, MS.
  • Phone Number: +86-021-64385700-3222
  • Email: wdgzkj@sina.com

Study Locations

  • China
      • Shanghai, China, 200032
        • Department of Nephrology,Longhua Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Remission rate of 24 hours urinary protein quantitative
Time Frame: two weeks to three months
two weeks to three months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Renal function, glomerular filtration rate (EPI formula), Plasma albumin
Time Frame: two weeks to three months
two weeks to three months
Blood lipid
Time Frame: half a year
half a year
Change of TCM Syndrome
Time Frame: two weeks to three months
two weeks to three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai University of Traditional Chinese Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Changhai Hospital
Fudan University
RenJi Hospital
Huashan Hospital
Tongji Hospital
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Ruijin Hospital
Chinese Academy of Sciences
Zhujiang Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Nanjing University of Traditional Chinese Medicine
Xinqiao Hospital of Chongqing
Shanghai Changzheng Hospital
ShuGuang Hospital
Shanghai Yueyang Integrated Medicine Hospital
Shanghai 6th People's Hospital
Shanghai Minhang Central Hospital
Guangxi Traditional Chinese Medical University
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Shanghai Putuo District Center Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZY3-CCCX-3-2001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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