To Evaluate the Functional Recovery Effect of Bloodletting Puncture at Jing-well Points on Acute Brain Injury Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- GCS(Glasgow Coma Scale)
研究概览
简要总结
Traumatic brain injury (Traumatic brain injury, TBI) can be derived from various forms of injury, including blunt trauma, penetrating or acceleration/deceleration force caused by head injury.There are some study data show that acupuncture treatment has a superficial effect on the prognosis of traumatic brain injury and can limit the progression of secondary brain injury, but the effect of early bloodletting at the Jing-points on TBI patients still unknown. In our study, the investigators have proposed a randomized, controlled study design and plan to evaluate the efficacy and safety of Jing-point puncture to improve consciousness and neurological function in patients with TBI. In addition, an objective meridian instrument analysis was added to analyze the energy distribution in the meridian of TBI patients.
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
- None
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
- 否
入选标准
- •Patient with moderate to severe head injury are admitted to the ICU (Intensive Care Unit). patient with stable vital sign and the GCS (Glasgow coma volume) between 5-13 will be included.
- •Patient with normal consciousness and no cognitive or motor function disease before brain injury.
- •Patient aged between 20 to 80 years old and is willing to sign the consent (the agent can sign on behalf of patient).
排除标准
- •Patients who are vital sign unstable and with severe complication.
- •Patients combined with other terminal illness such as cancer in terminal stage, liver failure, end stage renal failure and so on.
- •Pregnant patients.
- •Any other conditions deemed unsuitable by the physician in charge.
- •Patients (agent of the patient) who did not sign the consent.
结局指标
主要结局
GCS(Glasgow Coma Scale)
时间窗: 4 weeks
To assess the recovery of consciousness. Lower GCS scores are correlated with higher risk of death.
Barthel index
时间窗: 4 weeks
To assess the activities of daily life.
Muscle power
时间窗: 4 weeks
To assess the recovery of muscle power.
mGOS(Modified Glasgow Outcome Score)
时间窗: 4 weeks
To assess the neurological outcomes, score 1 to 5. the higher the score, the better outcome.
RTS (Revised Trauma Score)
时间窗: 4 weeks
To assess the physiologic condition of patients. The Revised Trauma Score is made up of a three categories: Glasgow Coma Scale, systolic blood pressure, and respiratory rate. The score range is 0-12. A lower score indicates a higher severity of injury.
次要结局
- Meridian energy assessment(4 weeks)