The Effect of Danzhu Fuyuan Granule as Adjunctive Therapy for Chronic Stable Angina, Vascular Dementia and Idiopathic Membranous Nephropathy: A Bayesian Basket Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 7
- 主要终点
- 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
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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
干预措施: Danzhu Fuyuan Granule (Drug)
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
干预措施: Danzhu Fuyuan Granule (Drug)
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
干预措施: Danzhu Fuyuan Granule (Drug)
结局指标
主要结局
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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Stopping or reducing rate of the Nitroglycerin Table(8 weeks)
- Level of blood urea nitrogen(6 months)
- Arterial systolic blood flow velocity mearsured by Transcranial Doppler(6 months)
- Duke treadmill score (DTS) at the end of week 8 compared with baseline on submaximal exercise Modified Bruce Protocol(8 weeks)
- Angina pectoris severity classification according to Canadian Cardiovascular Society (CCS)(8 weeks)
- the score on Seattle Angina Questionnaire(8 weeks)
- Frequency of weekly angina episodes(8 weeks)
- Brain pulse index mearsured by Transcranial Doppler(6 months)
- Level of serum creatinine(6 months)
- Number of subjects with adverse events or severe adverse events(8 weeks)
- Glomerular filtration rate(6 months)
- Mean flow velocity mearsured by Transcranial Doppler(6 months)
研究者
Jingqing Hu
Director of Institute of Basic Theory of Traditional Chinese Medicine
China Academy of Chinese Medical Sciences