Beijing Tiantan Hospital, Capital Medical University
Beijing, 100070, China
Location status: Recruiting
NCT Number: NCT07250035
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.
Interested in participating?
Request Info50 year–90 year
All sexes
Interventional
Phase 3
Beijing, 100070, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
⑥ Those who have received or are planning to undergo surgical treatment;
⑦ Those who suffer from other life-threatening serious diseases and have an expected survival time of less than six months;
⑧ Other conditions that significantly limit the evaluation of neurological function, prevent the completion of cranial magnetic resonance imaging, or affect the follow-up of patient;
⑨ Pregnant women, those planning to become pregnant or lactating women;
⑩Those who are currently participating in other interventional clinical trials.
Jiedu Huayu Oral Prescription in the Treatment of Intracranial Hemorrhage Associated with Cerebral Amyloid Angiopathy
A placebo similar to the Jiedu Huayu Oral Prescription
Time frame: 180 days after onset
Incidence of vascular events, including hemorrhagic and ischemic vascular events.
Time frame: 30 days after onset
Incidence of vascular events.
Time frame: 90 days after onset
Incidence of vascular events.
Time frame: 1 year after onset
Incidence of vascular events.
Time frame: 180 days after onset
Changes in neurocognitive function assessed by TICS-M, MMSE, and MOCA scales.
Time frame: 30 days after onset
Neurological function recovery evaluated by mRS score.
Time frame: 90 days after onset
Neurological function recovery evaluated by mRS score.
Time frame: 180 days after onset
Neurological function recovery evaluated by mRS score.
Time frame: 1 year after onset
Neurological function recovery evaluated by mRS score.
Time frame: 30 days after onset
Changes in quality of life assessed by SF-36 and EQ-5D scales.
Time frame: 90 days after onset
Changes in quality of life assessed by SF-36 and EQ-5D scales.
Time frame: 180 days after onset
Changes in quality of life assessed by SF-36 and EQ-5D scales.
Time frame: 1 year after discharge
Changes in quality of life assessed by SF-36 and EQ-5D scales.
Time frame: 7 days after onset
Hematoma expansion rate in safety indicators (defined as a 33% increase in hematoma volume or an absolute increase of 6ml compared with the baseline CT hematoma volume).
Time frame: 14 days after onset
Hematoma expansion rate in safety indicators (using the same evaluation standard as that at 7 days after onset).
Time frame: During medication
Incidence of newly developed severe liver and kidney function abnormalities in safety indicators.
Time frame: Entire study period
Incidence of non-vascular death, adverse events/serious adverse events reported by researchers.
Contact information is provided by the study sponsor or research team.
Beijing Tiantan Hospital
Other
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study of Jiedu Huayu Oral Prescription in the Treatment of Intracranial Hemorrhage Associated With Cerebral Amyloid Angiopathy
Acronym: CHN-CAA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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