search
Back to results

The Effect of Danzhu Fuyuan Granule as Adjunctive Therapy for Chronic Stable Angina, Vascular Dementia and Idiopathic Membranous Nephropathy: A Bayesian Basket Trial

Primary Purpose

Chronic Stable Angina, Vascular Dementia, Idiopathic Membranous Nephropathy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Danzhu Fuyuan Granule
Sponsored by
Jingqing Hu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stable Angina focused on measuring Danzhu Fuyuan Granule; Basket Trial

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Eligibility Criteria for Chronic Stable Angina group

Inclusion criteria for Chronic Stable Angina group

  1. Patient must be between the ages of 40 and 70 years
  2. Evidence of coronary artery disease that consists of a well-documented medical history (over 3 months prior to the enrollment) of myocardial infarction or significant coronary artery disease with noninvasive or angiographic confirmation.
  3. Patient must match the diagnostic criteria for chronic stable angina set by Chinese Medical Association;
  4. The number of angina pectoris attacked in the past 3 months was more than 2 times per week
  5. Class I or Class II, Grading of Angina Pectoris by the Canadian Cardiovascular Society Classification System
  6. Patients who met the clinical diagnostic criteria for Syndrome of intermingled phlegm and blood stasis with chronic stable angina;
  7. The results of Treadmill Exercise Test were positive;
  8. All other Traditional Chinese Medicine interventions (including decoction, granule, proprietary Chinese medicine, acupuncture, etc.) should be stopped for 2 weeks or more;
  9. They signed the consent form voluntarily and agreed to participate in the research.

Exclusion criteria for Chronic Stable Angina group

  1. patients who are diagnosed with acute coronary syndrome (including acute myocardial infarction or unstable angina pectoris) occurred within 2 months before enrollment, or had undergone revascularization within 3 months before enrollment, or planned to undergo revascularization during the study period;
  2. Patients who are unable to complete Treadmill Exercise Test for various reasons, including absolute and relative contraindications;
  3. Severe primary diseases such as respiratory, blood system or malignant tumor, or known renal insufficiency (serum creatinine (CR) > 221 umol /L in male, or 177 umol / L in female);
  4. Patients with epilepsy who had bleeding tendency, history of cerebral hemorrhage, or needed anticonvulsant therapy;
  5. Patients with active liver disease, or accompanied with unexplained continuous increase of serum transaminase, or the detection value of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) is more than twice the upper limit of normal reference value;
  6. Pregnancy or lactation;
  7. patients can't stopped taking long-acting nitrates during the clinical trial;
  8. undergoing other clinical trials;
  9. There was a history of alcoholism or drug dependence in the past two years;
  10. Other situations that the research physician thinks are not suitable to participate in this trial include but are not limited to: the subjects cannot follow the research protocol, which will bring potential safety hazards to the subjects, etc.

Eligibility Criteria for Vascular Dementia group

Inclusion criteria for Vascular Dementia group

  1. The age of the subjects was 35-85 years old;
  2. It was in accordance with the diagnostic standard of Western medicine for vascular dementia;
  3. It is in accordance with the diagnostic standard of TCM phlegm and blood stasis syndrome of vascular dementia;
  4. They signed informed consent and volunteered to participate in the study;
  5. The patients are expected to follow up within half a year.

Exclusion criteria for vascular dementia group

  1. Early memory impairment with progressive deterioration, early prominent features of Parkinson's disease, and primary nervous system diseases (such as multiple sclerosis, encephalitis, etc.);
  2. There was no vascular lesion in neuroimaging examination;
  3. Other diseases that can explain cognitive impairment, such as brain tumor, multiple sclerosis, encephalitis, depression, poisoning, and systemic diseases and metabolic abnormalities that significantly affect cognitive function;
  4. Severe heart, brain, liver and hematopoiesis diseases, or other serious diseases affecting their survival;
  5. Drug or alcohol abuse / dependence within 3 months before participating in the trial;
  6. Pregnant and lactating women;
  7. Patients with severe mental disorders (perception disorders, thinking disorders);
  8. For known renal insufficiency, serum creatinine (CR) was higher than 221 umol/L in male and 177 umol/L in female;
  9. Patients with known liver dysfunction, alanine aminotransferase (ALT) > 3 times of normal value or with cirrhosis;
  10. The researchers believe that there are other situations that are not suitable for participating in this study.

Eligibility Criteria for Idiopathic Membranous Nephropathy group

Inclusion criteria for Idiopathic Membranous Nephropathy group

  1. The pathological diagnosis of renal biopsy was membranous nephropathy;
  2. The syndrome of TCM is phlegm and blood stasis;
  3. The urinary protein was more than 1G / D and < 8g / d;
  4. Blood pressure can be effectively controlled at ≤ 140 / 90mmHg;
  5. eGFR≥45ml/min;
  6. The age ranged from 18 to 70 years old;
  7. Sign informed consent.

Exclusion criteria for Idiopathic Membranous Nephropathy group

  1. All kinds of secondary membranous nephropathy;
  2. Those who are taking hormone and / or immunosuppressive therapy;
  3. Women with pregnancy planning, pregnancy and lactation;
  4. Severe heart, brain, liver and hematopoiesis diseases, or other serious diseases affecting their survival;
  5. Participants in other clinical trials in recent 3 months.

Sites / Locations

  • Xiyuan hospital, China Academy of Chinese Medical Sciences
  • Fujian Provincial People's Hospital
  • The First Affiliated Hospital of Henan University of traditional Chinese Medicine
  • Hubei Provincial Hospital of Traditional Chinese Medicine
  • Yichang Hospital of Traditional Chinese Medicine
  • Affiliated Hospital of Jiangxi University of traditional Chinese Medicine
  • The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

chronic stable angina

Vascular Dementia

Idiopathic Membranous Nephropathy

Healthy population

Arm Description

Experimental: the patient who have the syndrome of intermingled phlegm and blood stasis with chronic stable angina will be treated by Danzhu Fuyuan Granule in addtion to routine care

Experimental: the patient who have the syndrome of intermingled phlegm and blood stasis with Vascular Dementia will be treated by Danzhu Fuyuan Granule in addtion to routine care

Experimental: the patient who have the syndrome of intermingled phlegm and blood stasis with Idiopathic Membranous Nephropathy will be treated by Danzhu Fuyuan Granule in addtion to routine care

Comparator: Healthy population with no treatment

Outcomes

Primary Outcome Measures

Primary endpoint 1 for Chronic Stable Angina Group: the time to ST depression at the end of week 8 compared with baseline on submaximal exercise Modified Bruce Protocol
It is suitable for Chronic Stable Angina group. The time to ST depression at the end of week 8 compared with baseline on submaximal exercise Modified Bruce Protocol
Primary endpoint 2 for Chronic Stable Angina group: the score on Syndrome Questionnaire of Intermingled Phlegm and Blood Stasis with Chronic Stable Angina at the end of week 8 compared with baseline
It is suitable for Chronic Stable Angina group. Syndrome Questionnaire of Intermingled Phlegm and Blood Stasis with Chronic Stable Angina is a questionnarie to evaluate the severity of Syndrome of Intermingled Phlegm and Blood Stasis with Chronic Stable Angina. The minimum score is 0 and the maximum score is 41. The higher the score is, the worse the outcomes is.
Primary endpoint 1 for Vascular Dementia group: the score of Mini-mental State Examination at the end of month 6 compared with baseline
It is suitable for Vascular Dementia group. Mini Mental State Examination gives the 'mini-mental state' examination of cognitive function. This is a 5-minute bedside test that is useful as a screen and in assessing the degree of cognitive dysfunction in patients with diffuse brain disorders. The minimum score is 0 and the maximum score is 30. The higher the score is, the better the outcomes is.
Primary endpoint 2 for Vascular Dementia group: the score on Syndrome Questionnaire of Intermingled Phlegm and Blood Stasis with Vascular Dementia at the end of month 6 compared with baseline
It is suitable for Vascular Dementia group Syndrome Questionnaire of Intermingled Phlegm and Blood Stasis with Vascular Dementia is a questionnarie to evaluate the severity of Syndrome of Intermingled Phlegm and Blood Stasis with Vascular Dementia. The minimum score is 0 and the maximum score is 46. The higher the score is, the worse the outcomes is.
Primary endpoint 1 for Idiopathic Membranous Nephropathy group: level of the 24 hour urine protein quantification at the end of month 6 compared with baseline
It is suitable for Idiopathic Membranous Nephropathy group. level of the 24 hour urine protein quantification at the end of month 6 compared with baseline. To evaluate the drug efficiency by comparing date changes of 24 hour urine protein quantification before and 6 months after treatment by Danzhu Fuyuan Granule . The unit of 24 hour urine protein quantification values is described as g/24h
Primary endpoint 2 for Idiopathic Membranous Nephropathy group: the score on Syndrome Questionnaire of Intermingled Phlegm and Blood Stasis with Idiopathic Membranous Nephropathy at the end of month 6 compared with baseline
It is suitable for Idiopathic Membranous Nephropathy group. Syndrome Questionnaire of Intermingled Phlegm and Blood Stasis withIdiopathic Membranous Nephropathy is a questionnarie to evaluate the severity of Syndrome of Intermingled Phlegm and Blood Stasis with Idiopathic Membranous Nephropathy. The minimum score is 0 and the maximum score is 42. The higher the score is, the worse the outcomes is.

Secondary Outcome Measures

Duke treadmill score (DTS) at the end of week 8 compared with baseline on submaximal exercise Modified Bruce Protocol
It is suitable for Chronic Stable Angina group. The Duke Treadmill Score was introduced in 1991 as a set of treadmill exercise findings that predict individual risk for death on the basis of a weighted combination of exercise duration, ST-segment depression, and the presence and nature of angina during testing. The score is calculated by subtracting 5 times the ST depression (in millimeters) and 4 times the angina score (no angina = 0, nonlimiting angina = 1, and test-limiting angina = 2) from minutes of exercise duration on the Modified Bruce protocol
the score on Seattle Angina Questionnaire
It is suitable for Chronic Stable Angina group. The Seattle Angina Questionnaire (SAQ) is a self-administered, disease-specific measure for patients with Cornary Artery Disease that is valid, reproducible, and sensitive to clinical change. The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).
Frequency of weekly angina episodes
It is suitable for Chronic Stable Angina group
Angina pectoris severity classification according to Canadian Cardiovascular Society (CCS)
It is suitable for Chronic Stable Angina group
Stopping or reducing rate of the Nitroglycerin Table
It issuitable for Chronic Stable Angina group
Number of subjects with adverse events or severe adverse events
It is suitable for Chronic Stable Angina group
Brain pulse index mearsured by Transcranial Doppler
It is suitable for Vascular Dementia group
Arterial systolic blood flow velocity mearsured by Transcranial Doppler
It is suitable for Vascular Dementia group
Mean flow velocity mearsured by Transcranial Doppler
It is suitable for Vascular Dementia group
Level of serum creatinine
It is suitable for Idiopathic Membranous Nephropathy group.
Level of blood urea nitrogen
It is sutitable for Idiopathic Membranous Nephropathy group.
Glomerular filtration rate
It is for idiopathic membranous nephropathy group. It was calculated according to ckD-EPI 2009 formula

Full Information

First Posted
July 21, 2020
Last Updated
July 30, 2020
Sponsor
Jingqing Hu
search

1. Study Identification

Unique Protocol Identification Number
NCT04498962
Brief Title
The Effect of Danzhu Fuyuan Granule as Adjunctive Therapy for Chronic Stable Angina, Vascular Dementia and Idiopathic Membranous Nephropathy: A Bayesian Basket Trial
Official Title
The Effect of Danzhu Fuyuan Granule as Adjunctive Therapy for Chronic Stable Angina, Vascular Dementia and Idiopathic Membranous Nephropathy: A Bayesian Basket Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2020 (Anticipated)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jingqing Hu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is designed as a bayesian basket trial , which aims to evaluate the efficacy of Danzhu Fuyuan Granule in patients with Chronic Stable Angina, Vascular Dementia and Idiopathic Membranous Nephropathy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stable Angina, Vascular Dementia, Idiopathic Membranous Nephropathy
Keywords
Danzhu Fuyuan Granule; Basket Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
chronic stable angina
Arm Type
Experimental
Arm Description
Experimental: the patient who have the syndrome of intermingled phlegm and blood stasis with chronic stable angina will be treated by Danzhu Fuyuan Granule in addtion to routine care
Arm Title
Vascular Dementia
Arm Type
Experimental
Arm Description
Experimental: the patient who have the syndrome of intermingled phlegm and blood stasis with Vascular Dementia will be treated by Danzhu Fuyuan Granule in addtion to routine care
Arm Title
Idiopathic Membranous Nephropathy
Arm Type
Experimental
Arm Description
Experimental: the patient who have the syndrome of intermingled phlegm and blood stasis with Idiopathic Membranous Nephropathy will be treated by Danzhu Fuyuan Granule in addtion to routine care
Arm Title
Healthy population
Arm Type
No Intervention
Arm Description
Comparator: Healthy population with no treatment
Intervention Type
Drug
Intervention Name(s)
Danzhu Fuyuan Granule
Intervention Description
Danzhu Fuyuan Granules,2 times / day, 1 bag / time, one time in the morning and one time in the evening. It is recommended to add the same amount of boiling water as the particles to soak for 30 seconds, and then add 5 times boiling water to dissolve until completely dissolved.The treatment cycle of each arm: 8 weeks for Chronic Stable Angina, 6 months for Vascular Dementia and 6 months for Idiopathic Membranous Nephropathy.
Primary Outcome Measure Information:
Title
Primary endpoint 1 for Chronic Stable Angina Group: the time to ST depression at the end of week 8 compared with baseline on submaximal exercise Modified Bruce Protocol
Description
It is suitable for Chronic Stable Angina group. The time to ST depression at the end of week 8 compared with baseline on submaximal exercise Modified Bruce Protocol
Time Frame
8 weeks
Title
Primary endpoint 2 for Chronic Stable Angina group: the score on Syndrome Questionnaire of Intermingled Phlegm and Blood Stasis with Chronic Stable Angina at the end of week 8 compared with baseline
Description
It is suitable for Chronic Stable Angina group. Syndrome Questionnaire of Intermingled Phlegm and Blood Stasis with Chronic Stable Angina is a questionnarie to evaluate the severity of Syndrome of Intermingled Phlegm and Blood Stasis with Chronic Stable Angina. The minimum score is 0 and the maximum score is 41. The higher the score is, the worse the outcomes is.
Time Frame
8 weeks
Title
Primary endpoint 1 for Vascular Dementia group: the score of Mini-mental State Examination at the end of month 6 compared with baseline
Description
It is suitable for Vascular Dementia group. Mini Mental State Examination gives the 'mini-mental state' examination of cognitive function. This is a 5-minute bedside test that is useful as a screen and in assessing the degree of cognitive dysfunction in patients with diffuse brain disorders. The minimum score is 0 and the maximum score is 30. The higher the score is, the better the outcomes is.
Time Frame
6 month
Title
Primary endpoint 2 for Vascular Dementia group: the score on Syndrome Questionnaire of Intermingled Phlegm and Blood Stasis with Vascular Dementia at the end of month 6 compared with baseline
Description
It is suitable for Vascular Dementia group Syndrome Questionnaire of Intermingled Phlegm and Blood Stasis with Vascular Dementia is a questionnarie to evaluate the severity of Syndrome of Intermingled Phlegm and Blood Stasis with Vascular Dementia. The minimum score is 0 and the maximum score is 46. The higher the score is, the worse the outcomes is.
Time Frame
6 month
Title
Primary endpoint 1 for Idiopathic Membranous Nephropathy group: level of the 24 hour urine protein quantification at the end of month 6 compared with baseline
Description
It is suitable for Idiopathic Membranous Nephropathy group. level of the 24 hour urine protein quantification at the end of month 6 compared with baseline. To evaluate the drug efficiency by comparing date changes of 24 hour urine protein quantification before and 6 months after treatment by Danzhu Fuyuan Granule . The unit of 24 hour urine protein quantification values is described as g/24h
Time Frame
6 months
Title
Primary endpoint 2 for Idiopathic Membranous Nephropathy group: the score on Syndrome Questionnaire of Intermingled Phlegm and Blood Stasis with Idiopathic Membranous Nephropathy at the end of month 6 compared with baseline
Description
It is suitable for Idiopathic Membranous Nephropathy group. Syndrome Questionnaire of Intermingled Phlegm and Blood Stasis withIdiopathic Membranous Nephropathy is a questionnarie to evaluate the severity of Syndrome of Intermingled Phlegm and Blood Stasis with Idiopathic Membranous Nephropathy. The minimum score is 0 and the maximum score is 42. The higher the score is, the worse the outcomes is.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Duke treadmill score (DTS) at the end of week 8 compared with baseline on submaximal exercise Modified Bruce Protocol
Description
It is suitable for Chronic Stable Angina group. The Duke Treadmill Score was introduced in 1991 as a set of treadmill exercise findings that predict individual risk for death on the basis of a weighted combination of exercise duration, ST-segment depression, and the presence and nature of angina during testing. The score is calculated by subtracting 5 times the ST depression (in millimeters) and 4 times the angina score (no angina = 0, nonlimiting angina = 1, and test-limiting angina = 2) from minutes of exercise duration on the Modified Bruce protocol
Time Frame
8 weeks
Title
the score on Seattle Angina Questionnaire
Description
It is suitable for Chronic Stable Angina group. The Seattle Angina Questionnaire (SAQ) is a self-administered, disease-specific measure for patients with Cornary Artery Disease that is valid, reproducible, and sensitive to clinical change. The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).
Time Frame
8 weeks
Title
Frequency of weekly angina episodes
Description
It is suitable for Chronic Stable Angina group
Time Frame
8 weeks
Title
Angina pectoris severity classification according to Canadian Cardiovascular Society (CCS)
Description
It is suitable for Chronic Stable Angina group
Time Frame
8 weeks
Title
Stopping or reducing rate of the Nitroglycerin Table
Description
It issuitable for Chronic Stable Angina group
Time Frame
8 weeks
Title
Number of subjects with adverse events or severe adverse events
Description
It is suitable for Chronic Stable Angina group
Time Frame
8 weeks
Title
Brain pulse index mearsured by Transcranial Doppler
Description
It is suitable for Vascular Dementia group
Time Frame
6 months
Title
Arterial systolic blood flow velocity mearsured by Transcranial Doppler
Description
It is suitable for Vascular Dementia group
Time Frame
6 months
Title
Mean flow velocity mearsured by Transcranial Doppler
Description
It is suitable for Vascular Dementia group
Time Frame
6 months
Title
Level of serum creatinine
Description
It is suitable for Idiopathic Membranous Nephropathy group.
Time Frame
6 months
Title
Level of blood urea nitrogen
Description
It is sutitable for Idiopathic Membranous Nephropathy group.
Time Frame
6 months
Title
Glomerular filtration rate
Description
It is for idiopathic membranous nephropathy group. It was calculated according to ckD-EPI 2009 formula
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Eligibility Criteria for Chronic Stable Angina group Inclusion criteria for Chronic Stable Angina group Patient must be between the ages of 40 and 70 years Evidence of coronary artery disease that consists of a well-documented medical history (over 3 months prior to the enrollment) of myocardial infarction or significant coronary artery disease with noninvasive or angiographic confirmation. Patient must match the diagnostic criteria for chronic stable angina set by Chinese Medical Association; The number of angina pectoris attacked in the past 3 months was more than 2 times per week Class I or Class II, Grading of Angina Pectoris by the Canadian Cardiovascular Society Classification System Patients who met the clinical diagnostic criteria for Syndrome of intermingled phlegm and blood stasis with chronic stable angina; The results of Treadmill Exercise Test were positive; All other Traditional Chinese Medicine interventions (including decoction, granule, proprietary Chinese medicine, acupuncture, etc.) should be stopped for 2 weeks or more; They signed the consent form voluntarily and agreed to participate in the research. Exclusion criteria for Chronic Stable Angina group patients who are diagnosed with acute coronary syndrome (including acute myocardial infarction or unstable angina pectoris) occurred within 2 months before enrollment, or had undergone revascularization within 3 months before enrollment, or planned to undergo revascularization during the study period; Patients who are unable to complete Treadmill Exercise Test for various reasons, including absolute and relative contraindications; Severe primary diseases such as respiratory, blood system or malignant tumor, or known renal insufficiency (serum creatinine (CR) > 221 umol /L in male, or 177 umol / L in female); Patients with epilepsy who had bleeding tendency, history of cerebral hemorrhage, or needed anticonvulsant therapy; Patients with active liver disease, or accompanied with unexplained continuous increase of serum transaminase, or the detection value of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) is more than twice the upper limit of normal reference value; Pregnancy or lactation; patients can't stopped taking long-acting nitrates during the clinical trial; undergoing other clinical trials; There was a history of alcoholism or drug dependence in the past two years; Other situations that the research physician thinks are not suitable to participate in this trial include but are not limited to: the subjects cannot follow the research protocol, which will bring potential safety hazards to the subjects, etc. Eligibility Criteria for Vascular Dementia group Inclusion criteria for Vascular Dementia group The age of the subjects was 35-85 years old; It was in accordance with the diagnostic standard of Western medicine for vascular dementia; It is in accordance with the diagnostic standard of TCM phlegm and blood stasis syndrome of vascular dementia; They signed informed consent and volunteered to participate in the study; The patients are expected to follow up within half a year. Exclusion criteria for vascular dementia group Early memory impairment with progressive deterioration, early prominent features of Parkinson's disease, and primary nervous system diseases (such as multiple sclerosis, encephalitis, etc.); There was no vascular lesion in neuroimaging examination; Other diseases that can explain cognitive impairment, such as brain tumor, multiple sclerosis, encephalitis, depression, poisoning, and systemic diseases and metabolic abnormalities that significantly affect cognitive function; Severe heart, brain, liver and hematopoiesis diseases, or other serious diseases affecting their survival; Drug or alcohol abuse / dependence within 3 months before participating in the trial; Pregnant and lactating women; Patients with severe mental disorders (perception disorders, thinking disorders); For known renal insufficiency, serum creatinine (CR) was higher than 221 umol/L in male and 177 umol/L in female; Patients with known liver dysfunction, alanine aminotransferase (ALT) > 3 times of normal value or with cirrhosis; The researchers believe that there are other situations that are not suitable for participating in this study. Eligibility Criteria for Idiopathic Membranous Nephropathy group Inclusion criteria for Idiopathic Membranous Nephropathy group The pathological diagnosis of renal biopsy was membranous nephropathy; The syndrome of TCM is phlegm and blood stasis; The urinary protein was more than 1G / D and < 8g / d; Blood pressure can be effectively controlled at ≤ 140 / 90mmHg; eGFR≥45ml/min; The age ranged from 18 to 70 years old; Sign informed consent. Exclusion criteria for Idiopathic Membranous Nephropathy group All kinds of secondary membranous nephropathy; Those who are taking hormone and / or immunosuppressive therapy; Women with pregnancy planning, pregnancy and lactation; Severe heart, brain, liver and hematopoiesis diseases, or other serious diseases affecting their survival; Participants in other clinical trials in recent 3 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xu Weiming, Doctor
Phone
86-1064089029
Email
15652608470@126.com
Facility Information:
Facility Name
Xiyuan hospital, China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100091
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Renhuan, Doctor
Phone
+86-13611196162
Email
tezhongeyu@vip.sina.com
Facility Name
Fujian Provincial People's Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350004
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Songfeng, Doctor
Phone
+86-13400561224
Email
zsf881210@126.com
Facility Name
The First Affiliated Hospital of Henan University of traditional Chinese Medicine
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duan Fei, Doctor
Phone
+86-18638601093
Email
kybduanfei@126.com
Facility Name
Hubei Provincial Hospital of Traditional Chinese Medicine
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shi Heyuan, Doctor
Phone
+86-13971278693
Email
shy79@hbtcm.edu.cn
Facility Name
Yichang Hospital of Traditional Chinese Medicine
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
443003
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhou Gang
Phone
+86-139865793257
Email
139865793257@126.com
Facility Name
Affiliated Hospital of Jiangxi University of traditional Chinese Medicine
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Zhongyong, Doctor
Phone
+86-1064089029
Email
lzyongmail@163.com
Facility Name
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300151
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhao Yingqiang, Doctor
Phone
13920089969
Email
zhaoyingqiang1000@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Danzhu Fuyuan Granule as Adjunctive Therapy for Chronic Stable Angina, Vascular Dementia and Idiopathic Membranous Nephropathy: A Bayesian Basket Trial

We'll reach out to this number within 24 hrs