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Clinical Evaluation of Herbal Medicine (ICH-012) in Treating Acute Cerebral Haemorrhage: Safety and Efficacy from 6- to 72-Hour Time Window (CRRICHTrial-II)

机译:中草药治疗急性脑出血的临床评价(ICH-012):6到72小时时间窗内的安全性和有效性(CRRICHTrial-II)

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摘要

Background Hypertensive intracerebral haemorrhage (HICH), which is characterized by rapid change, high morbidity, and mortality, is extremely dangerous. Both medical and surgical treatments lack definitive evidence and remain controversial. A prospective RCT that we have conducted has shown that the usage of the herbal medicine ICH-012 within 6 h of the event may increase the risk of haematoma enlargement and gastrointestinal bleeding. However, the volume of haematoma remains stable after 6 h. Thus, we will increase the time window to the period from 6 to 72 h after onset to evaluate the safety and efficacy of ICH-012 treating ICH (ClinicalTrial.gov ID: ).
机译:背景技术高血压脑出血(HICH)具有快速变化,高发病率和高死亡率的特点,是极为危险的。药物和外科治疗均缺乏确切的证据,并仍存在争议。我们进行的一项前瞻性RCT研究表明,事件发生后6小时内使用草药ICH-012可能会增加血肿扩大和胃肠道出血的风险。但是,血肿量在6小时后仍保持稳定。因此,我们将在发病后的6至72小时内增加时间窗口,以评估ICH-012治疗ICH的安全性和有效性(ClinicalTrial.gov ID:)。

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