Jiedu Huayu Oral Prescription in the Treatment of Intracranial Hemorrhage Associated With Cerebral Amyloid Angiopathy
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Jiedu Huayu Oral Prescription, Placebo.
- Кому может быть актуально
- Состояния в реестре: Cerebral Amyloid Angiopathy. Базовые параметры: 50 лет — 90 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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
Обзор
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.
Подробное описание
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.
Вмешательства
- Препарат Jiedu Huayu Oral Prescription
Jiedu Huayu Oral Prescription in the Treatment of Intracranial Hemorrhage Associated with Cerebral Amyloid Angiopathy - Препарат Placebo
A placebo similar to the Jiedu Huayu Oral Prescription
Первичные конечные точки
- Vascular events [Срок оценки: 180 days after onset]
Вторичные конечные точки (12)
- Incidence of Vascular Events at 30 Days [Срок оценки: 30 days after onset]
- Incidence of Vascular Events at 90 Days [Срок оценки: 90 days after onset]
- Incidence of Vascular Events at 1 Year [Срок оценки: 1 year after onset]
- Changes in Neurocognitive Function [Срок оценки: 180 days after onset]
- Neurological Function Recovery at 30 Days [Срок оценки: 30 days after onset]
- Neurological Function Recovery at 90 Days [Срок оценки: 90 days after onset]
- Neurological Function Recovery at 180 Days [Срок оценки: 180 days after onset]
- Neurological Function Recovery at 1 Year [Срок оценки: 1 year after onset]
- Changes in Quality of Life at 30 Days [Срок оценки: 30 days after onset]
- Changes in Quality of Life at 90 Days [Срок оценки: 90 days after onset]
- Changes in Quality of Life at 180 Days [Срок оценки: 180 days after onset]
- Changes in Quality of Life at 1 Year [Срок оценки: 1 year after discharge]
Критерии участия
Критерии включения
- ① Possible or very likely CAA-ICH;
- Within 7 days of onset; ③ Primary supratentorial intracerebral hemorrhage (bleeding volume ≤40ml);
- GCS≥8 points;
- NIHSS score ≤25 points; ⑥50≤age≤90 years old; ⑦ Gender is not limited; ⑧ The subject or their legal representative gives informed consent and signs the informed consent form.
Критерии исключения
- Those who are known to be allergic to the components of the traditional Chinese medicine compound used in the experiment;
- It is known that after treatment with vascular malformations, aneurysms, coagulation disorders, anticoagulant or antiplatelet drugs, Intracranial conditions caused by clear etiologies such as thrombolytic therapy, post-infarction hemorrhage transformation, hematological diseases, moyamoya disease, etc;
- Patients with traumatic intracranial hemorrhage;
- Patients with active peptic ulcers or other clear tendencies of rebleeding;
- Patients with severe liver or kidney dysfunction (Note: Severe liver dysfunction is defined as ALT or AST being greater than.
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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Beijing Tiantan Hospital, Capital Medical University — Пекин
Идентификаторы
NCT: NCT07250035 · 2024ZD0522204