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临床试验/NCT01840761
NCT01840761Unknown4 期

Delayed Vasospasm After Aneurysm With the Standardization Treatment of Traditional Chinese Medicine

Guangzhou University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
60
试验地点
1
主要终点
The incidence of DCVS after aneurysmal postoperative

研究概览

简要总结

Delayed vasospasm (DCVS) is the most serious complication of aneurysmal subarachnoid hemorrhage (aSAH) perioperative period ,the incidence rate up to 30% to 90%, and often can cause severe brain ischemia or brain damage of delayed ischemic and even lead to cerebral infarction, to be the main factor of deadly and severe disability . (aSAH) perioperative delayed vasospasm (CVS) is the bottleneck to restrict the long-term effect. Since there is no standard clinical treatment programs, limiting the advantages and characteristics of traditional Chinese medicine to play.Guangdong Provincial Hospital of TCM is the province's Medical Center encephalopathy, treated 100 brain aneurysm patients each year, more than 80 times craniotomies and surgical interventions , with a rich source of patiengs to carry out the study. In this study, on the basis studies on hemorrhagic stroke of a yin and yang syndrome and comprehensive treatment programe of the State 1995,the 15th research , in accordance with characteristics of the pathophysiology and understanding of cause and pathogenesis in aSAH perioperative period , through expert advice and review of the literature, under the guidance of Liu Maocai who isChinese medicine practitioners of Guangdong province , from diagnosis, diagnosis and treatment,prescription drugs, and other aspects of efficacy evaluation, developmenting a standardized treatment program of delayed CVS after aSAH . To evaluate the efficacy of the standardized program by prospective, randomized,controlled clinical trial,improving the postoperative results, reducting significantly the mortality and morbidity patients with cerebral aneurysms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
14 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 14-80 years old patients;
  • Comply with the diagnostic criteria for Chinese and Western medicine;
  • Comply with embolization of intracranial aneurysms or cranial aneurysm surgery indications;
  • Preoperative Hunt and Hess grade of Ⅰ ~ Ⅳ; The first disease or previous history of stroke but no sequelae;
  • Acceptance within 72h onset cranial aneurysm embolization or craniotomy aneurysm surgeon;
  • Informed consent;

排除标准

  • The age of 14 years of age or in patients over 80 years of age;
  • By hypertension, a variety of blood diseases, amyloid angiopathy, cerebral arteritis, cerebral abnormal vascular network (moyamoya disease), brain tumor brain metastases as a result of bleeding;
  • Associated with cardiovascular, liver and kidney and hematopoietic system of primary disease, mental illness;
  • 72h of onset did not receive cranial aneurysm embolization or craniotomy for aneurysm surgery were;

研究组 & 干预措施

herbal drug

Experimental

Traditional Chinese herbal drug

干预措施: herbal drug (Drug)

Placebo

Placebo Comparator

干预措施: placebo (Drug)

结局指标

主要结局

The incidence of DCVS after aneurysmal postoperative

时间窗: 3 months

after 3-months chinese medicine treatment, through evaluating the incidence of delayed vasospasm after cerebral aneurysms , to assess the efficacy of Chinese medicine

次要结局

  • 1 month, 3 month mortality(14days,1 month,3 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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