Idiopathic Membranous NephropathyNCT02610595
Study on the Therapeutic Effect of TCM Treatment for MDR MN
A study testing Jianpixiaozhong particles and Wuse Dietotherapy in people with Idiopathic Membranous Nephropathy, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Idiopathic Membranous Nephropathy
- What is being tested?
- Jianpixiaozhong particles and Wuse Dietotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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）
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nephrology,Longhua Hospital
Shanghai, 200032
YueYI Deng, Dr., 64385700 ext. 3222, lhkidney@hotmail.com
About this study
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)
To evaluate the effectiveness and safety of the Chinese medicine treatment for multiple drug resistance of MN patients with Jianpiyiqi and Huoxuejiedu Recipe.
Read the 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.
- Conditions
- Idiopathic Membranous Nephropathy
- Being tested
- Jianpixiaozhong particles and Wuse Dietotherapy
- Keywords
- Idiopathic Membranous Nephropathy, Jianpiyiqi Recipe, Huoxuejiedu Recipe, Effectiveness, Safety
- Medical subject headings
- Glomerulonephritis, Membranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jianpixiaozhong particles and Wuse DietotherapyDrug
Jianpixiaozhong particles: Three packs once,bid po; Wuse Dietotherapy: one packs once,bid po
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Jianpixiaozhong particles and Wuse Dietotherapy Receives: Drug: Jianpixiaozhong particles and Wuse Dietotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission rate of 24 hours urinary protein quantitative
Measured: two weeks to three months
Secondary outcomes (3)
Renal function, glomerular filtration rate (EPI formula), Plasma albumin
Measured: two weeks to three months
Blood lipid
Measured: half a year
Change of TCM Syndrome
Measured: two weeks to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Membranous NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610595
- Sponsor's protocol ID
- ZY3-CCCX-3-2001
- Status last verified
- Aug 2015
- First submitted
- 18 Nov 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02610595
- Acronym / sponsor ID
- ZY3-CCCX-3-2001
- Conditions
- Idiopathic Membranous Nephropathy
- Keywords
- Idiopathic Membranous Nephropathy, Jianpiyiqi Recipe, Huoxuejiedu Recipe, Effectiveness, Safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- 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
- Study start
- Dec 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Jianpixiaozhong particles and Wuse DietotherapyJianpixiaozhong particles and Wuse Dietotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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）
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jianpixiaozhong particles and Wuse DietotherapyJianpixiaozhong particles: Three packs once,bid po; Wuse Dietotherapy: one packs once,bid po | Drug | experimental group |
Primary outcome
Remission rate of 24 hours urinary protein quantitative
Time frame: two weeks to three months
3 secondary outcomes
Renal function, glomerular filtration rate (EPI formula), Plasma albumin
Time frame: two weeks to three months
Blood lipid
Time frame: half a year
Change of TCM Syndrome
Time frame: two weeks to three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jianpixiaozhong particles and Wuse Dietotherapy in people with Idiopathic Membranous Nephropathy, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yueyi Deng, MD. (+86-021-64385700-3226, dengyueyi@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission rate of 24 hours urinary protein quantitative (time frame: two weeks to three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.