A Randomized Controlled Trial of Wendan Decoction as a Palliative Treatment for Acute Brain Injury
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Glasgow coma scale
研究概览
简要总结
Efficacy and safety of Traditional Chinese Medicine (Wendan decoction) combined with conventional neurologic intensive care in patients with acute moderated to severe brain injury in early stage - A randomized controlled study.
详细描述
This study adopted a prospective, randomized controlled design. All eligible patients included in the study agreed to participated and signed the informed consent from and the study procedures were approved by the ethical committee of Taichung Tzu Chi general hospital (REC103-26). Patients were recruited from the neurosurgery department of Taichung Tzu Chi general hospital between June 2014 and July 2015. A total of 60 patients were enrolled in this study and randomized into intervention group and control group. All patients of both groups were enrolled within 14 days after episode and a follow-up interview until 6 months from the onset. The intervention group mean regular neuro-intensive care combined TCM and the intervention group mean only neuro-intensive care. But there are 7 patients in intervention group and 12 patients in control group quit out this study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
no masking design
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •traumatic brain injury or spontaneously intracerebral hemorrhage within 14 days of onset;
- •an initial score of 3-12 points of GCS score;
- •adults between 18 to 80 years old;
- •and signed informed consent form.
排除标准
- •after 14 days of onset;
- •a history of previous TBI or stroke;
- •intracranial aneurysm or arteriovenous malformation ruptured;
- •combination other major organ injury (heart, lung, intra-abdomen organ, pelvic fracture, major vessels);
- •other severe disease such as heart or kidney failure;
- •previous diagnosed cancer; and pregnant women.
研究组 & 干预措施
neurologic intensive care in acute brain injury
With the guidance of Taiwan Neurosurgical Society and Taiwan Neurological Society, patients in the control group were given the consistent treatment. (http://www.neurosurgery.org.tw/nsr/tbi/main.htm and http://www.stroke.org.tw/guideline/guideline_1.asp). The intensive treatments were established according to the traumatic brain injury treatment guidelines and spontaneously intracerebral hemorrhage general treatment principles from these two society in Taiwan.
干预措施: Wendan decoction combination in acute brain injury (Drug)
结局指标
主要结局
Glasgow coma scale
时间窗: 1 month
from 3 to 15 , higher value indicate better outcome
Ventilator use
时间窗: 1 month
how many days of ventilator use
ICU stay
时间窗: 1 month
how many days of ICU stay
Disability rating scale
时间窗: 1 month
from 0 to 29 , higher value mean worse outcome
modified Rankin scale
时间窗: 1 month
from 0 to 6 , 0 mean normal and 6 mean dead , higher value indicated worse outcome
mortality
时间窗: 1 month
between 1 month mortality
次要结局
- Glasgow coma scale(6 month)
- modified Rankin scale(6 month)
- Disability rating scale(6 month)
- Barthel index(6 months)
研究者
Borren Huang
Director of Neurosurgery department
Taichung Tzu Chi Hospital