研究疾病:
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中风病
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研究疾病代码:
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Target disease:
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Ischemic Stroke
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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其它
Others
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研究目的:
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采用多中心、随机、对照试验设计,将通督调神针法与假针刺进行对照研究,明确脑卒中病针刺干预与否的疗效差别,探讨针灸治疗缺血性脑卒中的优化方案。
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Objectives of Study:
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With a multicenter, randomized, controlled trial design, a comparative study was conducted between Tongdu Tiaoshen acupuncture and sham acupuncture, to clarify the difference in the curative effect of acupuncture intervention on stroke, and to explore the optimal scheme of acupuncture in the treatment of ischemic stroke.
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药物成份或治疗方案详述:
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Description for medicine or protocol of treatment in detail:
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纳入标准:
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1.缺血性脑卒中后 3-14 天患者;
2.年龄18-75 岁;
3.意识清楚,生命体征平稳,无明显智障,简易智能量表(Mini-Mental State Examination, MMSE)评分在正常范围(正常界值:文盲>17 分,小学>20 分,初中及以上>24 分),能配合针灸、康复训练及相关基础治疗;
4.卒中前改良 Rankin 量表(Modified Rankin Score, mRS)评分 ≤1 分;发 病后美国国立卫生研究院卒中量表(National Institute of Health stroke scale, NIHSS)评分在 5-15 之间;
5.了解试验并签署知情同意书者。
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Inclusion criteria
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1.Patients 3-14 days after ischemic stroke;
2.18-75 years old Patients;
3.Clear consciousness, stable vital signs, no obvious mental retardation, Mini-Mental State Examination score in the normal range (normal boundary value: illiteracy > 17, primary school > 20, junior high school and above > 24), can cooperate with acupuncture, rehabilitation training and related basic treatment;
4.The score of modified Rankin scale (mRS) before stroke was less than 1, and the score of National Institutes of Health Stroke scale (NIHSS) after stroke was 5-15.
5.Those who understand the test and sign the informed consent form.
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排除标准:
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1.短暂性脑缺血发作,可逆性神经功能缺损;
2.经检查证实神经功能缺损由脑肿瘤、脑外伤、脑出血、脑寄生虫等疾病引起 者,脑卒中以外的其他原因的预期寿命小于 1 年患者;
3.针灸禁忌症患者,或脑卒中合并有严重循环系统、呼吸系统、消化系统、泌 尿系统、内分泌系统和造血系统等原发性疾病且常规用药无法控制的患者;合并肿瘤 的患者,有严重感染、水、电解质及酸碱平衡紊乱的患者;或其他检查异常研究者判 断不适合参与此试验的患者;
4.合并严重失语症、睡眠呼吸暂停、耳聋、严重认知障碍以至无法正常交流者; 或正在参加其他临床研究试验者;
5.严重抑郁、焦虑患者,或有其他精神疾病的患者;
6.怀孕或计划怀孕的妇女。
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Exclusion criteria:
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1.Transient ischemic attack, reversible neurological deficit;
2.Patients confirmed by examination that the life expectancy of patients with neurological impairment caused by brain tumor, brain trauma, cerebral hemorrhage, cerebral parasite and other causes other than stroke is less than 1 year.
3.Patients with acupuncture contraindications, or stroke patients with severe primary diseases such as circulatory system, respiratory system, digestive system, urinary system, endocrine system and hematopoietic system, which can not be controlled by routine medication; patients with tumors, patients with severe infection, water, electrolyte and acid-base balance disorders, or other abnormal researchers judged to be unsuitable to participate in this trial.
4.Those with severe aphasia, sleep apnea, deafness, severe cognitive impairment and inability to communicate normally; or those who are participating in other clinical trials;
5.Patients with severe depression, anxiety, or other mental disorders;
6.Woman who is pregnant or plans to become pregnant.
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研究实施时间:
Study execute time:
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从From
2020-01-01
至To
2023-12-31
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征募观察对象时间:
Recruiting time:
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从From
2022-01-08
至To
2023-12-31
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