Cognitive function evaluation of first-episode cerebral infarction and early intervention of traditional Chinese Medicine

注册号:

Registration number:

ITMCTR2000004118

最近更新日期:

Date of Last Refreshed on:

2020-12-01

注册时间:

Date of Registration:

2020-12-01

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

首发脑梗死认知功能评价及中药早期干预研究

Public title:

Cognitive function evaluation of first-episode cerebral infarction and early intervention of traditional Chinese Medicine

注册题目简写:

English Acronym:

研究课题的正式科学名称:

首发脑梗死认知功能评价及中药早期干预研究

Scientific title:

Cognitive function evaluation of first-episode cerebral infarction and early intervention of traditional Chinese Medicine

研究课题的正式科学名称简写:

Scientific title acronym:

研究课题代号(代码):

Study subject ID:

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:

ChiCTR2000040496 ; ChiMCTR2000004118

申请注册联系人:

游毅

研究负责人:

游毅

Applicant:

You Yi

Study leader:

You Yi

申请注册联系人电话:

Applicant telephone:

+86 13564579857

研究负责人电话:

Study leader's telephone:

+86 13564579857

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:

767876934@qq.com

研究负责人电子邮件:

Study leader's E-mail:

767876934@qq.com

申请单位网址(自愿提供):

Study leader's 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:

上海市虹口区长阳路303号5号楼5楼

研究负责人通讯地址:

上海市虹口区长阳路303号5号楼5楼

Applicant address:

303 Changyang Road, Hongkou District, Shanghai, China

Study leader's address:

303 Changyang Road, Hongkou District, Shanghai, 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:

上海中医药大学附属上海市中西医结合医院

Applicant's institution:

Shanghai TCM-intergrated Hospital Affiliated to Shanghai University of TCM

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2020-102-1

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

上海中医药大学附属上海市中西医结合医院伦理委员会

Name of the ethic committee:

Ethics Committee of Shanghai TCM-intergrated Hospital Affiliated to Shanghai University of TCM

伦理委员会批准日期:

Date of approved by ethic committee:

1990/1/1 0:00:00

伦理委员会联系人:

吴仪涵

Contact Name of the ethic committee:

Wu Yihan

伦理委员会联系地址:

上海市虹口区保定路230号

Contact Address of the ethic committee:

230 Baoding Road, Hongkou District, Shanghai, China

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:

上海中医药大学附属上海市中西医结合医院

Primary sponsor:

Shanghai TCM-intergrated Hospital Affiliated to Shanghai University of TCM

研究实施负责(组长)单位地址:

上海市虹口区保定路230号

Primary sponsor's address:

230 Baoding Road, Hongkou District, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属上海市中西医结合医院

具体地址:

上海市虹口区保定路230号

Institution
hospital:

Shanghai TCM-intergrated Hospital Affiliated to Shanghai University of TCM

Address:

230 Baoding Road, Hongkou District, Shanghai

经费或物资来源:

上海市虹口区卫生健康委员会

Source(s) of funding:

Shanghai Hongkou Municlpal Health Commission

研究疾病:

卒中后认知障碍

研究疾病代码:

Target disease:

Post-stroke cognitive impairment

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

1)早期发现首发脑梗死患者非痴呆性血管性认知功能障碍患者; 2)评价早期进行中药干预,是否能缩短首发脑梗死疗程,改善非痴呆性血管性认知功能障,提供一种临床治疗手段;

Objectives of Study:

1) Early detection of first-episode cerebral infarction patients with non dementia vascular cognitive impairment; 2) Objective to evaluate whether early intervention with traditional Chinese medicine can shorten the course of treatment of the first cerebral infarction and improve vascular cognitive impairment without dementia.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

①符合脑梗死诊断标准,且为首次脑梗死; ②符合中医证候诊断标准; ③年龄在45岁以上,80岁以下; ④病程在1个月以内 ⑤意识清楚,无明显语言理解和表达障碍⑥.中医辩证为肾虚髓亏,痰瘀阻窍证。

Inclusion criteria

1. Meet the diagnostic criteria of cerebral infarction, and it is the first cerebral infarction; 2. Meet the diagnostic criteria of TCM syndromes; 3. Over 45 years old and under 80 years old; 4. Course of disease within 1 month; 5. Clear consciousness, no obvious Language comprehension and expression barriers; 6. TCM dialectics are kidney deficiency and marrow deficiency, phlegm and blood stasis blocking orifice syndrome.

排除标准:

①严重的脑萎缩或白质疏松者; ②有意识障碍或伴有感觉性失语或运动性失语而影响语言交流者; ③因严重视、听功能障碍、失用不能配合检查者; ④伴心、肺、肝、肾功能不全,血液病或肿瘤者; ⑤严重脑外伤或神经外科手术史致认知损害者; ⑥可影响认知功能的其他神经系统疾病(如严重的帕金森病、正常颅压脑积水、脑出血、脑肿瘤、脑炎等); ⑦既往有智能障碍或精神疾病者; ⑧妊娠期或哺乳期妇女; ⑨过敏体质者

Exclusion criteria:

1. Severe brain atrophy or leukoaraiosis; 2. Persons with consciousness disturbance or accompanied by sensory aphasia or motor aphasia that affect language communication; 3. Due to severe visual and auditory dysfunction, Apraxia and unable to cooperate with the examination; 4. with heart, lung, liver, kidney insufficiency, blood disease or tumor; 5. severe brain injury or neurosurgery history caused cognitive impairment; 6. may affect cognitive function Other neurological diseases (such as severe Parkinsons disease, normal intracranial pressure, hydrocephalus, cerebral hemorrhage, brain tumors, encephalitis, etc.); 7. Persons with previous intellectual disabilities or mental illnesses; 8. Women during pregnancy or lactation, People with allergies.

研究实施时间:

Study execute time:

From 2020-06-30

To      2022-06-30

征募观察对象时间:

Recruiting time:

From 2020-12-01

To      2022-03-01

干预措施:

Interventions:

组别:

对照组

样本量:

35

Group:

Control group

Sample size:

干预措施:

常规治疗+安慰剂

干预措施代码:

Intervention:

Conventional treatment plus placebo

Intervention code:

组别:

治疗组

样本量:

35

Group:

experimental group

Sample size:

干预措施:

常规治疗+通脉复智方

干预措施代码:

Intervention:

Conventional treatment plus Tongmai Fuzhi Decoction

Intervention code:

样本总量 Total sample size : 70

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属上海市中西医结合医院

单位级别:

三甲医院

Institution/hospital:

Shanghai TCM-intergrated Hospital Affiliated to Shanghai University of TCM

Level of the institution:

Tertiary A Hospital

测量指标:

Outcomes:

指标中文名:

蒙特利尔认知评估量表

指标类型:

主要指标

Outcome:

Montreal Cognitive Assessment

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

事件相关电位P300

指标类型:

主要指标

Outcome:

event-related potentials P300

Type:

Primary 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:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小
Min age years
最大
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

采用分层随机法(使用SPSS23.0 Transformation的功能产生随机数字,随机序列平均分配到2组,信封隐藏)。每个临床观察医师根据受试者进入研究的时间先后顺序,被依次随机分配至不同的组别。治疗组与对照组各35例。

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

Adopt the stratified random method (use the function of SPSS23.0 Transformation to generate random numbers, the random sequences are equally distributed to 2 groups, and the envelope is hidden). Each clinical observation physician is randomly assigned to different groups according to the time sequence of the subjec

盲法:

未说明

Blinding:

Not stated

是否共享原始数据:

IPD sharing:

Yes

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):

试验完成后6个月内公开

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

Within six months after the trial complete

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:

病例记录表

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

CRF

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above