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

Jingqing Hu

Status: Unknown

Conditions: Vascular Dementia; Idiopathic Membranous Nephropathy; Chronic Stable Angina

Treatments: Drug: Danzhu Fuyuan Granule

Study type: Interventional

Funder types: Other

Identifiers

NCT04498962

2019YFC1708500

Details and patient eligibility

About

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

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 4 patient groups

chronic stable angina

Experimental group

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

Treatment:

Drug: Danzhu Fuyuan Granule

Vascular Dementia

Experimental group

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

Treatment:

Drug: Danzhu Fuyuan Granule

Idiopathic Membranous Nephropathy

Experimental group

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

Treatment:

Drug: Danzhu Fuyuan Granule

Healthy population

No Intervention group

Description:

Comparator: Healthy population with no treatment