Cerebral hemorrhage, as a serious cerebrovascular disease, has the highest disability rate and mortality rate among all types of cerebrovascular diseases .It has brought a heavy burden to society. In China, the incidence of cerebral hemorrhage is much higher than that in Europe and America, and cerebral amyloid angiopathy (CAA) is one of the causes of primary cerebral hemorrhage However, there are relatively few related studies. Therefore, the research object of this subject focuses on patients with cerebral amyloid angiopathy, in view of their high recurrence rate of vascular events and the lack of treatment methods.It aims to deeply explore the detoxification and blood stasis removal treatment plan combining traditional Chinese and Western medicine to reduce vascular events for patients.
Cerebral hemorrhage, as a serious cerebrovascular disease, has the highest disability rate and mortality rate among all types of cerebrovascular diseases .It has brought a heavy burden to society. In China, the incidence of cerebral hemorrhage is much higher than that in Europe and America, and cerebral amyloid angiopathy (CAA) is one of the causes of primary cerebral hemorrhage However, there are relatively few related studies. Therefore, the research object of this subject focuses on patients with cerebral amyloid angiopathy, in view of their high recurrence rate of vascular events and the lack of treatment methods.It aims to deeply explore the detoxification and blood stasis removal treatment plan combining traditional Chinese and Western medicine to reduce vascular events for patients. It is expected that this will be systematically evaluated through a multi-center, randomized, double-blind, mimic-controlled clinical trial.The effectiveness and safety of the protocol in reducing the incidence of vascular events were observed, and its impact on patients' cognitive function and neurological function was also examined. The research plan includes patients with CAA-related intracranial hemorrhage within 7 days of onset.The therapeutic effect was measured by indicators such as the proportion of vascular events in patients at different stages of the disease, including hematoma expansion rate and abnormal liver and kidney functions.The safety was evaluated based on the incidence rate, and the anti-inflammatory, antioxidant and other properties of traditional Chinese medicine prescriptions were explored with the aid of imaging and biological indicators.The mechanism for improving cerebrovascular function. It is expected that through this study, it will provide clinical treatment for patients with CAA-related intracranial hemorrhage.A brand-new and effective plan brings better prognosis to patients, reduces the medical burden on patients' families and lowers the social burden medical costs. At the same time, it will also provide important reference basis for subsequent related research and promote the integrated treatment of traditional Chinese and Western medicine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
436
Jiedu Huayu Oral Prescription in the Treatment of Intracranial Hemorrhage Associated with Cerebral Amyloid Angiopathy
A placebo similar to the Jiedu Huayu Oral Prescription
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
Vascular events
Incidence of vascular events, including hemorrhagic and ischemic vascular events.
Time frame: 180 days after onset
Incidence of Vascular Events at 30 Days
Incidence of vascular events.
Time frame: 30 days after onset
Incidence of Vascular Events at 90 Days
Incidence of vascular events.
Time frame: 90 days after onset
Incidence of Vascular Events at 1 Year
Incidence of vascular events.
Time frame: 1 year after onset
Changes in Neurocognitive Function
Changes in neurocognitive function assessed by TICS-M, MMSE, and MOCA scales.
Time frame: 180 days after onset
Neurological Function Recovery at 30 Days
Neurological function recovery evaluated by mRS score.
Time frame: 30 days after onset
Neurological Function Recovery at 90 Days
Neurological function recovery evaluated by mRS score.
Time frame: 90 days after onset
Neurological Function Recovery at 180 Days
Neurological function recovery evaluated by mRS score.
Time frame: 180 days after onset
Neurological Function Recovery at 1 Year
Neurological function recovery evaluated by mRS score.
Time frame: 1 year after onset
Changes in Quality of Life at 30 Days
Changes in quality of life assessed by SF-36 and EQ-5D scales.
Time frame: 30 days after onset
Changes in Quality of Life at 90 Days
Changes in quality of life assessed by SF-36 and EQ-5D scales.
Time frame: 90 days after onset
Changes in Quality of Life at 180 Days
Changes in quality of life assessed by SF-36 and EQ-5D scales.
Time frame: 180 days after onset
Changes in Quality of Life at 1 Year
Changes in quality of life assessed by SF-36 and EQ-5D scales.
Time frame: 1 year after discharge
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