The Effect of Danzhu Fuyuan Granule as Adjunctive Therapy for Chronic Stable Angina, Vascular Dementia and Idiopathic Membranous Nephropathy: A Bayesian Basket Trial
NCT ID: NCT04498962
Last Updated: 2020-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
240 participants
INTERVENTIONAL
2020-08-31
2021-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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chronic stable angina
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
Danzhu Fuyuan Granule
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.
Vascular Dementia
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
Danzhu Fuyuan Granule
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.
Idiopathic Membranous Nephropathy
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
Danzhu Fuyuan Granule
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.
Healthy population
Comparator: Healthy population with no treatment
No interventions assigned to this group
Interventions
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Danzhu Fuyuan Granule
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.
Eligibility Criteria
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Inclusion Criteria
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.
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.
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
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
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
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.
18 Years
70 Years
ALL
Yes
Sponsors
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Jingqing Hu
OTHER
Responsible Party
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Jingqing Hu
Director of Institute of Basic Theory of Traditional Chinese Medicine
Locations
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Xiyuan hospital， China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Fujian Provincial People's Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Henan University of traditional Chinese Medicine
Zhengzhou, Henan, China
Hubei Provincial Hospital of Traditional Chinese Medicine
Wuhan, Hubei, China
Yichang Hospital of Traditional Chinese Medicine
Wuhan, Hubei, China
Affiliated Hospital of Jiangxi University of traditional Chinese Medicine
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019YFC1708500
Identifier Type: -
Identifier Source: org_study_id
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