Overview

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

Status:
Not yet recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
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
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Jingqing Hu
Criteria
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.