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Clinic research of 'tiao shen yi zhi' Acupuncture for Mild Cognitive impairment after cerebral infarction
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注册号:

Registration number:

ChiCTR-IOR-15007366 

最近更新日期:

Date of Last Refreshed on:

2015-11-10 

注册时间:

Date of Registration:

2015-11-04 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

“调神益智”针刺法治疗脑梗死后轻度认知障碍的临床研究 

Public title:

Clinic research of 'tiao shen yi zhi' Acupuncture for Mild Cognitive impairment after cerebral infarction 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

“调神益智”针刺法治疗脑梗死后轻度认知障碍的临床研究 

Scientific title:

Clinic research of 'tiao shen yi zhi' Acupuncture for Mild Cognitive impairment after cerebral infarction 

研究课题代号(代码):

Study subject ID:

JDZX2012139 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

王淑华 

研究负责人:

郑健刚 

Applicant:

shuhua wang 

Study leader:

Jiangang zheng 

申请注册联系人电话:

Applicant telephone:

+86 13032235836 

研究负责人电话:

Study leader's telephone:

+86 13821908899 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

381443206@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

jgzheng2008@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

天津市西青区李七庄街昌凌路88号 

研究负责人通讯地址:

天津市西青区李七庄街昌凌路88号 

Applicant address:

88 Changling road, Liqizhuang street, Xiqing district, Tianjin, China 

Study leader's address:

88 Changling road, Liqizhuang street, Xiqing district, Tianjin, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

天津中医药大学第一附属医院 

Applicant's institution:

First teaching hospital of Tianjin University of traditional Chinese Medicine 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

TYLL2013[K]字 002 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

天津中医药大学第一附属医院医学伦理委员会 

Name of the ethic committee:

IEC of the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

天津中医药大学第一附属医院 

Primary sponsor:

First teaching hospital of Tianjin University of traditional Chinese Medicine 

研究实施负责(组长)单位地址:

天津市西青区李七庄街昌凌路88号 

Primary sponsor's address:

88 Changling road, Liqizhuang street, Xiqing district, Tianjin, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

天津

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津中医药大学第一附属医院

具体地址:

天津市西青区李七庄街昌凌路88号

Institution
hospital:

First teaching hospital of Tianjin University of traditional Chinese Medicine

Address:

88 Changling road, Liqizhuang street, Xiqing district, Tianjin, China

经费或物资来源:

国家中医药管理局 

Source(s) of funding:

state administration of Traditional Chinese Medicine 

研究疾病:

脑梗死后轻度认知障碍 

Target disease:

Mild Cognitive Impairment after cerebral infarction 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

比较“调神益智”针法,尼莫地平以及针药结合治疗脑梗死后轻度认知障碍的临床疗效,客观评价针刺治疗价值,优化临床治疗方案。 

Objectives of Study:

Compare the clincal efficacy of "tiao shen yi zhi" acupuncture,Nimodipine and the combination of acupuncture with Nimodipine for Mild Cognitive Impairment after cerebral infarction.Objective evaluation of the therapeutic value of acupuncture, optimized clinical treatment. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1) 符合脑梗死后轻度认知障碍缺血性诊断标准;(2) 符合临床痴呆评定表(CDR)评分不超过0.5分;(3) MoCA评分符合认知障碍标准<26分;(4) Hamilton抑郁量表量表评分<8分;(5) Hachinski缺血指数>7分;(6) 体重在50~90kg之间,年龄50~80岁,男女均可;(7) 脑梗死病史至少2周以上,半年之内;(8) 肌力3级及以上,无语言障碍;(9) 有一定文化程度,既往能阅读简单的报纸文章和写简单的小文章;(10)自愿者,良好的依从性并签订知情同意书; 

Inclusion criteria

1. Comply with mild cognitive impairment after cerebral ischemia diagnostic criteria; 2. Consistent with CDR and no more than 0.5 points; 3. score of MOCA is in line with standard of cognitive impairment,and <26; 4. the score of Hamilton<8; 5. the score of Hachinski>7; 6. Weighing between 50 ~ 90kg, aged 50 to 80 years, both men and women; 7. Within ischemic stroke for at least two weeks to six months; 8. Muscle is 3 or above, no language barriers; 9. There is a certain level of education, previous to read simple newspaper articles and write simple little article; 10. Volunteer who have good compliance and signed informed consent. 

排除标准:

(1)符合痴呆诊断。早期表现记忆缺损或其他认知功能障碍,且进行性加重。影像学没有相应的缺血性病灶;(2)由脑梗死以外的原因,如脑出血、脑炎、癫痫、肿瘤、多发性硬化、精神病、甲状腺功能低下、酗酒或药物滥用等导致的认知障碍;严重的视力、听力障碍,严重的失语或肢体力弱影响检查者;(3)患有某些能干扰认知功能评价疾病,其中包括嗜酒的病人,头部损伤患有认知障碍者或在过去5年内经DSM-IV标准诊断为吸毒或其他精神性药物滥用者;(4)抑郁症或其他精神障碍;(5)有其他疾病,尤其肝、肾或心功能衰竭者,如ALT或AST在正常值3倍以上者,或血清肌酐(Scr)>177LmolL者,或心功能2~4级者,心率<50次/分或>110次/分,参加试验前4个月内发生过心肌梗死、致命性心律失常;(6)其他可引起认知损害的疾病,如恶性肿瘤、甲状腺功能异常、梅毒以及严重贫血病人;(7)糖尿病未能控制的病人。哮喘和慢性阻塞性肺病患者。多发神经炎患者。重症肌无力和肌萎缩患者。青光眼患者。有严重消化不良,或胃肠道梗阻,或胃和十二指肠溃疡的病人,以及能影响药物吸收的其他胃肠道疾病的病人;(8)在过去30天内曾用过同类药物治疗。如服用过相关或相拮抗作用的药物,药物的疗效难以判断者;(9)对本研究药物过敏者。 

Exclusion criteria:

1. In line with the diagnosis of dementia.There is manifestation of memory impairment or other cognitive dysfunction in early stage, and progressive increase. Imaging is no corresponding ischemic lesions; 2. Cognitive impairment by a reason other than the cause of cerebral infarction,such as Cerebral hemorrhage, encephalitis, epilepsy, cancer, multiple sclerosis, mental illness, hypothyroidism, alcohol or drug abuse. People who has severe vision, hearing impairment, severe aphasia or limb weak and effect the inspection; 3. Suffering from certain diseases can interfere with cognitive function evaluation, like alcoholics, a cognitive impairment caused by head injury, to be addicts over the past 5 years by the standard of DSM-IV or Other psychotropic drugs abusers; 4. Depression or other mental disorders; 5. There are other diseases, especially liver, kidney or heart failure, like the ALT or AST in more than three times normal, Scr>177Lmol, or Heart function 2 to 4, HR<50 or >110, people who had myocardial infarction or fatal arrhythmias before 4 months of participating in the trial; 6. Other diseases that can cause cognitive impairment, like Cancer, thyroid dysfunction, syphilis and severe anemia patient; 7. Patients with uncontrolled diabetes. Asthma and chronic obstructive pulmonary disease. Patients with multiple neuritis. Patients with myasthenia gravis and amyotrophic. Glaucoma patients. Severe indigestion, gastrointestinal obstruction or ulcer of stomach and duodenal and other gastrointestinal disorders that can affect drug absorption; 8. Over the past 30 days had used similar medications, such as taking over related or antagonistic effects of drugs, so that the efficacy of the drug is difficult to judge; 9. Have allergy to the drug of the study. 

研究实施时间:

Study execute time:

From2013-01-01To 2014-12-01 

干预措施:

Interventions:

组别:

针刺组

样本量:

42

Group:

acupuncture group

Sample size:

干预措施:

单纯针刺

干预措施代码:

Intervention:

acupuncture

Intervention code:

组别:

西药组

样本量:

42

Group:

Western medicine group

Sample size:

干预措施:

尼莫地平

干预措施代码:

Intervention:

Nimodipine

Intervention code:

组别:

针药结合组

样本量:

42

Group:

the combination group of acupuncture with Nimodipine

Sample size:

干预措施:

针刺结合尼莫地平

干预措施代码:

Intervention:

acupuncture and Nimodipine

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津中医药大学第一附属医院 

单位级别:

三甲医院 

Institution
hospital:

First teaching hospital of Tianjin University of traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

疗效

指标类型:

主要指标 

Outcome:

Efficacy

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

蒙特利尔认知评估量表

指标类型:

次要指标 

Outcome:

MOCA

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

神经精神量表

指标类型:

次要指标 

Outcome:

Neuropsychiatric Inventory

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

日常生活能力量表

指标类型:

次要指标 

Outcome:

Activity of daily living scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

社会活动功能量表

指标类型:

次要指标 

Outcome:

functional activities questionnaire

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血管性痴呆的辨证及疗效评价标准

指标类型:

次要指标 

Outcome:

SDSVD

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

功能活动量表

指标类型:

次要指标 

Outcome:

FAQ

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

尿液

组织:

Sample Name:

Urine

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

便

组织:

Sample Name:

Defecate

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 50 years
最大 Max age 80 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

非试验研究人员采用随机数字表

Randomization Procedure (please state who generates the random number sequence and by what method):

Non-experimental researchers use a random number table

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-11-04
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