Longhua Hospital, Shanghai University of TCM
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 194
- 主要终点
- NIHSS SCALE
研究概览
简要总结
This project optimizes the TCM Symptoms and Symptoms Scale. A curative effect evaluation system of acupuncture in the treatment of acute ischemic stroke is formed to provide clinical evidence by the following indexes: neurological impairment, motor dysfunction, TCM Symptoms and Symptoms Scale, combined with the patients' head MRI, Plasma BDNF, MMP-9 and other biomarkers.
详细描述
Based on the previous work, this project optimizes the TCM Symptoms and Symptoms Scale. Through the cohort study method, 194 patients with acute ischemic stroke were evaluated for neurological impairment, motor dysfunction, TCM Symptoms and Symptoms Scale, combined with the patients' head MRI. , Plasma BDNF, MMP-9 and other biomarkers, screen TCM syndromes related to stroke outcome indicators, and adopt targeted comprehensive acupuncture and moxibustion program intervention and follow-up to establish a stroke-specific intervention outcome prediction model with TCM characteristics. A curative effect evaluation system of acupuncture and moxibustion in the treatment of acute ischemic stroke is formed to provide clinical evidence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) It meets the diagnostic criteria in the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2014"; with the support of brain CT or MRI imaging examination, the vital signs are stable, the state of consciousness is clear, and the GCS>8 points; （2）.Onset is less than 2 weeks; （3）. There is no indication for thrombolysis, or the patient do not accept thrombolysis; （4）. For moderate to severe patients, the National Institute of Health Stroke Scale (NIHSS) ≥ 4 points;（5）.Glasgow coma standard (GCS)>7 points;（6）.No serious disability before admission, and modified Rankin Scale (mRS) ≤ 3;（7）. The patient himself or his immediate family members signed the informed consent form.
排除标准
- •(1) Cerebral hemorrhage or subarachnoid hemorrhage; (2) Cerebellar and brainstem infarction (including lacunar infarction); (3) Cerebral herniation is formed upon admission; (4) Patients with severe heart, lung, liver, and kidney diseases; (5) Severe upper gastrointestinal bleeding occurred after the onset; (6) The patient has participated in other clinical trials within the past 3 months; (7) Patients with mental illness, or those with severe cognitive impairment (MMSE score ≤9 points) (8) Those with a pacemaker, a metal foreign body at the treatment site, or a severe bleeding tendency.
- •(9) The investigator believes that other diseases accompanied by the patient may interfere with the correct evaluation of neurological function, or participating in this trial may cause other complications in the patient.
结局指标
主要结局
NIHSS SCALE
时间窗: 4 weeks
NIHSS was created by the National Institutes of Health and has good reliability and validity. It has been widely used to evaluate the severity and prognosis of stroke. The scale consists of consciousness, gaze, vision, facial paralysis, movement, sensation, mutual aid, language, neglect and other items, with a maximum score of 33 points.
次要结局
- Stroke Scale of Traditional Chinese Medicine, SSTCM(4 weeks)
- modified Barthel Index, mBI(4 weeks)