The Effect of Danzhu Fuyuan Granule as Adjunctive Therapy for Chronic Stable Angina, Vascular Dementia and Idiopathic Membranous Nephropathy: A Bayesian Basket Trial
- Conditions
- Chronic Stable AnginaVascular DementiaIdiopathic Membranous Nephropathy
- Interventions
- Drug: Danzhu Fuyuan Granule
- Registration Number
- NCT04498962
- Lead Sponsor
- Jingqing Hu
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 240
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description chronic stable angina Danzhu Fuyuan Granule 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 Vascular Dementia Danzhu Fuyuan Granule 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 Idiopathic Membranous Nephropathy Danzhu Fuyuan Granule 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
- Primary Outcome Measures
Name Time Method 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 8 weeks 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 8 weeks 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 6 month 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 6 month 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 6 months 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 6 months 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
Name Time Method Stopping or reducing rate of the Nitroglycerin Table 8 weeks It issuitable for Chronic Stable Angina group
Level of blood urea nitrogen 6 months It is sutitable for Idiopathic Membranous Nephropathy group.
Arterial systolic blood flow velocity mearsured by Transcranial Doppler 6 months It is suitable for Vascular Dementia group
Duke treadmill score (DTS) at the end of week 8 compared with baseline on submaximal exercise Modified Bruce Protocol 8 weeks 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
Angina pectoris severity classification according to Canadian Cardiovascular Society (CCS) 8 weeks It is suitable for Chronic Stable Angina group
the score on Seattle Angina Questionnaire 8 weeks 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 8 weeks It is suitable for Chronic Stable Angina group
Brain pulse index mearsured by Transcranial Doppler 6 months It is suitable for Vascular Dementia group
Level of serum creatinine 6 months It is suitable for Idiopathic Membranous Nephropathy group.
Number of subjects with adverse events or severe adverse events 8 weeks It is suitable for Chronic Stable Angina group
Glomerular filtration rate 6 months It is for idiopathic membranous nephropathy group. It was calculated according to ckD-EPI 2009 formula
Mean flow velocity mearsured by Transcranial Doppler 6 months It is suitable for Vascular Dementia group
Trial Locations
- Locations (7)
Hubei Provincial Hospital of Traditional Chinese Medicine
🇨🇳Wuhan, Hubei, China
Yichang Hospital of Traditional Chinese Medicine
🇨🇳Wuhan, Hubei, China
Fujian Provincial People's Hospital
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Henan University of traditional Chinese Medicine
🇨🇳Zhengzhou, Henan, China
Xiyuan hospital， China Academy of Chinese Medical Sciences
🇨🇳Beijing, Beijing, 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, China