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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
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.
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
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
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 6 month
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.
Time frame: 6 month
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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
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
Time frame: 6 months
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.
Time frame: 6 months
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
Time frame: 8 weeks
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).
Time frame: 8 weeks
Frequency of weekly angina episodes
It is suitable for Chronic Stable Angina group
Time frame: 8 weeks
Angina pectoris severity classification according to Canadian Cardiovascular Society (CCS)
It is suitable for Chronic Stable Angina group
Time frame: 8 weeks
Stopping or reducing rate of the Nitroglycerin Table
It issuitable for Chronic Stable Angina group
Time frame: 8 weeks
Number of subjects with adverse events or severe adverse events
It is suitable for Chronic Stable Angina group
Time frame: 8 weeks
Brain pulse index mearsured by Transcranial Doppler
It is suitable for Vascular Dementia group
Time frame: 6 months
Arterial systolic blood flow velocity mearsured by Transcranial Doppler
It is suitable for Vascular Dementia group
Time frame: 6 months
Mean flow velocity mearsured by Transcranial Doppler
It is suitable for Vascular Dementia group
Time frame: 6 months
Level of serum creatinine
It is suitable for Idiopathic Membranous Nephropathy group.
Time frame: 6 months
Level of blood urea nitrogen
It is sutitable for Idiopathic Membranous Nephropathy group.
Time frame: 6 months
Glomerular filtration rate
It is for idiopathic membranous nephropathy group. It was calculated according to ckD-EPI 2009 formula
Time frame: 6 months