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临床试验/NCT03271697
NCT03271697Unknown2 期

Efficacy Study of Astragalus Membranaceus on Aneurysmal Subarachnoid Hemorrhage

China Medical University Hospital0 个研究点目标入组 120 人开始时间: 2017年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
120
主要终点
Clinical symptom

研究概览

简要总结

This research is trying to see if AM can enhance the clinical prognosis for spontaneous aneurysm ruptured subarachnoid hemorrhage patients.

详细描述

Astragalus membranaceus (AM, Huang-Chi) is a Chinese herb used extensively in China as a traditional treatment to treat stroke for a long time, and a number of studies have shown that AM can reduce cerebral infarction area and has anti-oxidation activity. Our previous studies have demonstrated enhanced recovery of neurologic function in patients with acute hemorrhagic stroke who received AM. It is hypothesized that AM either reduces inflammatory response or reduces perihematomal edema.

Subarachnoid hemorrhage secondary to rupture of a cerebral aneurysm is a medical condition associated with a high morbidity and mortality; approximately 10-15% of patients die before reaching medical care, and overall mortality is approximately 45%. Of those that survive, 30% suffer permanent disability graded as moderate to severe, and two-thirds of survivors never return to the same quality of life as they had prior to their hemorrhage. A large number of patients (30-70%) who are able to make it to the hospital and have successful treatment of their aneurysm will develop delayed cerebral vasospasm that is related to the blood clot from their initial aneurysm rupture. Of patients that survive their initial aneurysm rupture, vasospasm results in an additional 7% mortality and another 7% of severe disabilities secondary to ischemic strokes from severe spasm of cerebral arteries.

This research is trying to see if AM can enhance the clinical prognosis for spontaneous aneurysm ruptured subarachnoid hemorrhage patients. All procedures done as a part of this study are standard hospital care procedures done to treat aneurysmal subarachnoid hemorrhage according to the AHA/ASA guideline.

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
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • Patients who admitted to the hospital within 24 hours of onset of aneurysmal subarachnoid hemorrhage (SAH) stroke
  • Subarachnoid hemorrhage documented on head CT
  • Hunt Hess Grade 1-4
  • Both Male and Female
  • Age more than 20 and less than 80 years older
  • Informed consent obtained from a patient or legal representative before enrollment

排除标准

  • Traumatic or mycotic aneurysms
  • Complication of serious heart or hepatic disease or infection or renal failure
  • Malignant tumor
  • Patients judged to be inappropriate by physician in charge
  • Pregnant / breast feeding women
  • Patients have enrolled or have not yet completed other investigational drug trials within 1 month before screening
  • Ever stroke, and mRS≧3

研究组 & 干预措施

AM group

Experimental

Treatment group will accept Astragalus Membranaceus(AM) t.i.w treatment for 14 days from second day of admission, in addition to standard ordinary treatment.

干预措施: Astragalus Membranaceus (Drug)

Placebo group

Placebo Comparator

Control group will accept placebo t.i.w treatment for 14 days from the second day of admission, in addition to standard ordinary treatment.

干预措施: Placebo (Drug)

结局指标

主要结局

Clinical symptom

时间窗: 90 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage

evaluating recovery scale percentage at 90 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage

次要结局

  • IL-6(14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage)
  • IL-1β(14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage)
  • TNF-α(14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage)
  • S100-β(14 days post discharge following AM treatment for aneurysmal subarachnoid hemorrhage)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chun-Chung Chen

Attending Surgeon

China Medical University Hospital

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