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中风后认知功能障碍中医康复治疗方案的规范化研究
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注册号:

Registration number:

ChiCTR1900027849 

最近更新日期:

Date of Last Refreshed on:

2019-11-30 

注册时间:

Date of Registration:

2019-11-30 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中风后认知功能障碍中医康复治疗方案的规范化研究 

Public title:

A study for the standardization of TCM rehabilitation program for post-stroke cognitive impairment 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中风后认知功能障碍中医康复治疗方案的规范化研究 

Scientific title:

A study for the standardization of TCM rehabilitation program for post-stroke cognitive impairment 

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:

ChiMCTR1900025385 

申请注册联系人:

苏凯奇 

研究负责人:

冯晓东 

Applicant:

Su Kaiqi 

Study leader:

Feng Xiaodong 

申请注册联系人电话:

Applicant telephone:

+86 18703876378 

研究负责人电话:

Study leader's telephone:

+86 0371-66249043 

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:

surgdy1008@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

fxd0502@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:

河南省郑州市郑东新区龙子湖高校园区河南中医药大学 

研究负责人通讯地址:

河南省郑州市人民路19号 

Applicant address:

Henan University of Chinese Medicine, Longzihu High Campus, Zhengdong New District, Zhengzhou, He'nan, China 

Study leader's address:

19 Renmin Road, Zhengzhou, He'nan, 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:

河南中医药大学 

Applicant's institution:

He'nan University of 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:

2019HL-102-01 

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:

河南中医药大学第一附属医院伦理委员会 

Name of the ethic committee:

Ethics committee of The First Affiliated Hospital of He'nan University of Chinese Medicine  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-09-05 

伦理委员会联系人:

王春芳 

Contact Name of the ethic committee:

Wang Chunfang 

伦理委员会联系地址:

郑州市人民路19号 

Contact Address of the ethic committee:

19 Renmin Road, Zhengzhou, He'nan, 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:

河南中医药大学第一附属医院 

Primary sponsor:

The First Affiliated Hospital of He'nan University of Chinese Medicine  

研究实施负责(组长)单位地址:

河南中医药大学第一附属医院 

Primary sponsor's address:

19 Renmin Road, Zhengzhou, He'nan, 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):

河南省

市(区县):

郑州市

Country:

China

Province:

He'nan

City:

Zhengzhou

单位(医院):

河南中医药大学第一附属医院

具体地址:

河南省郑州市人民路19号

Institution
hospital:

The First Affiliated Hospital of Henan University of Chinese Medicine

Address:

19 Renmin Road, Zhengzhou

经费或物资来源:

河南省中医管理局 

Source(s) of funding:

He'nan Province Traditional Chinese Medicine Administration 

研究疾病:

中风后认知功能障碍 

Target disease:

post-stroke cognitive impairment 

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:

采用多中心、前瞻性、大样本、随机对照的临床研究,评价中医综合康复治疗方案治疗中风后认知功能障碍的临床疗效和安全性,形成科学、规范、适于推广应用的中医临床康复治疗方案。 

Objectives of Study:

A multicenter, prospective, large-sample, randomized controlled clinical study was used to evaluate the clinical efficacy and safety of TCM comprehensive rehabilitation treatment schemes for treating post-stroke cognitive impairment, and form a scientific, standardized and traditional Chinese medicine clinical rehabilitation treatment scheme suitable for promotion and application. 

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)符合脑卒中诊断,且经CT或MRI检查明确的患者; (2)MMSE量表筛查和MOCA评估量表均确认有认知障碍; (3)认知障碍于脑卒中发生后出现,并排除其他原因引起; (4)病程在1个月至1年之内;入组前未使用任何改善认知的药物; (5)意识清醒,生命体征平稳; (6)年龄30岁至75岁; (7)本人或法定监护人同意并已签定知情同意书。 

Inclusion criteria

(1) Patients who meet the diagnosis of stroke and are confirmed by CT or MRI; (2) Both MMSE scale screening and MOCA assessment scale confirmed cognitive impairment; (3) Cognitive impairment occurs after the occurrence of stroke, and other causes are excluded; (4) The course of disease is within one month to one year; no cognition-improving drugs have been used before enrollment; (5) Sober consciousness and stable vital signs; (6) Aged 30 to 75 years; (7) The patient or his/her legal guardian agrees and has signed an informed consent. 

排除标准:

(1)存在能够导致认知障碍的非卒中疾病如烦内占位病变、脑外伤、动脉血管瘤等; (2)伴有严重影响认知检查的疾病如视听功能异常、精神异常等; (3)本次生病之前存在认知明显减退或痴呆病史; (4)伴有其它严重疾病如免疫疾病、内分泌疾病及肝肾功能异常等疾病者; (5)妊娠及哺乳期女性; (6)正在参加影响本研究结果评价的其他临床试验者。 

Exclusion criteria:

(1) There are non-stroke diseases that can cause cognitive impairment, such as annoying space occupying lesions, brain trauma, and arterial hemangioma; (2) Diseases with severely affecting cognitive tests, such as abnormal audiovisual and mental disorders; (3) A history of significant cognitive decline or dementia before the illness; (4) Patients with other serious diseases such as immune diseases, endocrine diseases and abnormal liver and kidney functions; (5) pregnant and lactating women; (6) Other clinical trial participants who are influencing the evaluation of the results of this study. 

研究实施时间:

Study execute time:

From2018-12-01To 2021-12-01 

征募观察对象时间:

Recruiting time:

From2019-12-01To 2021-12-01 

干预措施:

Interventions:

组别:

试验组

样本量:

103

Group:

Experimental group

Sample size:

干预措施:

基础治疗+电针+留针1小时+认知训练

干预措施代码:

Intervention:

Basic therapy + electroacupuncture + needle retention for 1 hour+ cognitive training

Intervention code:

组别:

对照组

样本量:

103

Group:

Control group

Sample size:

干预措施:

基础治疗+电针+认知训练

干预措施代码:

Intervention:

Basic therapy + electroacupuncture + cognitive training

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河南省 

市(区县):

郑州市 

Country:

China 

Province:

He'nan 

City:

Zhengzhou 

单位(医院):

河南中医药大学第一附属医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital of Henan University of Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

河南省 

市(区县):

郑州市 

Country:

China 

Province:

He'nan 

City:

 

单位(医院):

河南省中医院 

单位级别:

三甲医院 

Institution
hospital:

Henan Province Hospital of TCM  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

河南省 

市(区县):

郑州市 

Country:

China 

Province:

He'nan 

City:

Zhengzhou 

单位(医院):

河南中医药大学第三附属医院 

单位级别:

三甲医院 

Institution
hospital:

The Third Affiliated Hospital of Henan University of Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

简易智能精神状态量表

指标类型:

主要指标 

Outcome:

Simple intelligent mental state scale

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:

主要指标 

Outcome:

Montreal cognitive assessment scale

Type:

Primary 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:

Daily living ability scale

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:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 30 years
最大 Max age 75 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):

委托非课题组成员的第三方负责随机,随机对照严格采用中心随机的方法进行控制,并对随机分配方案进行隐藏。随机分配方案采用SAS统计分析系统的PROCPLAN过程生成,对符合纳入标准的病人,按照1:1的比例随机分配到本试验的2个组。

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

A third party who is not a member of the research team is entrusted to be responsible for randomization. The random control is strictly controlled by the central random method, and the random allocation scheme is hidden. The random allocation plan was generated using the PROCPLAN process of the SAS.

盲法:

研究采用盲法评价,分别由不知分组情况的第三方进行疗效评价和随访观察。资料总结阶段采用盲法统计分析,实行研究者、操作者、统计者三分离原则。

Blinding:

The study was evaluated blindly. Efficacy evaluation and follow-up observation were performed by a third party who did not know the grouping. The data summary phase uses blind statistical analysis and implements the principle of separation of researchers, operators, and statisticians.

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

是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):

2021年10月

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

In October 2021

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:

一、数据采集 数据采集实行双人双次录入,分别由数据录入员和研究者完成一、二次录入,保证研究数据的录入客观、准确。 二、数据管理 1 定义原始数据 (1)受试者的医疗文件,包括门诊病历、住院病历、理化检查报告等。 (2)临床研究过程文件,包括知情同意书、筛选表、入选表、用药记录、实验室记录、科研病例、病例报告表等。 2 数据记录与保存的规定 (1)数据录入采用二次录入方法,由不同录入人员分别重复录入同一份病例报告表格,以两次或两人的输入值相互核对,两者一致的存入数据库。 (2)研究者应当保证临床研究的病例报告表(CRF)和所需报告中的数据的准确性、完整性、易辨性、及时性以及可溯源性。遵守源文件保存和查阅规定。数据收集要求及时、完整、准确。①及时:数据应在8小时内完成原始记录,24小时内完成病例观察表的记录;②完整:收集研究数据,就是要求收集所有研究对象的全部数据;③准确:研究者在收集资料或填写观察表格时需经过一定的培训,或者至少需要在填写前熟悉填写要求和注意事项,并通过检查来确认所有的资料收集者都能较为一致地掌握资料的收集方法。 (2)为保证国家中医药管理局和研究单位的评价与监督,研究者应保存所有研究资料,包括对所有参加受试者的确认(能有效地核对不同的记录资料,如CRF表和医院原始记录)、所有原始的有签名的患者知情同意书、所有CRF表、药品发放的详细记录等。当课题通过鉴定验收后,将所有研究资料转交课题负责单位科研管理处,并保存至研究结束后5年。 3 数据报告的方式 每个临床试验中心应在完成至少5份CRF后,通过临床监查员及时送交数据管理员,以便建立相应的数据库,所有数据将采用计算机软件编制数据录入程序进行双份录入。数据管理员保证将CFR表数据完整真实的录入计算机。 4 数据核查的规定 对数据进行盲态审核,并认为所建立的数据库正确后,将由主要研究者、统计分析人员对数据进行锁定。锁定后的数据文件不允许再作变动。数据库将交统计分析人员按统计计划书要求进行统计分析。 5 数据疑问与答疑的规定 有疑问的数据表通过临床监查员转交研究者进行数据审核,研究者应尽快回答并返回。

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

Data collection Data acquisition is performed by double entry, which is completed by data entry personnel and researchers respectively, so as to ensure the objectivity and accuracy of research data entry. Data management define the raw data (1) medical documents of subjects, including outpatient medical records, inpatient medical records, physical and chemical examination reports, etc. (2) clinical research process documents, including informed consent form, screening form, inclusion form, medication record, laboratory record, scientific research case, case report form, etc. 2. Provisions for data recording and preservation (1) data entry adopts the method of secondary entry, in which the same case report form is repeatedly entered by different input personnel, and the input values of two or more people are checked with each other, and the two are stored in the database in accordance with each other. (2) researchers should ensure the accuracy, integrity, legibility, timeliness and traceability of the case report form (CRF) and the data in the required reports. Comply with source document storage and access regulations. Data collection should be timely, complete and accurate. (1) timely: the original records of data should be completed within 8 hours, and the records of case observation table should be completed within 24 hours; (2) complete: collect research data, is required to collect all the research objects of all the data; (3) accuracy: researchers need to go through certain training when collecting data or filling in observation forms, or at least be familiar with filling in requirements and precautions before filling in, and check to ensure that all data collectors can relatively uniformly grasp the data collection methods. (2) to ensure that the state administration of traditional Chinese medicine and the research units of evaluation and supervision, researchers should keep all information, including confirmation of all the participants in subjects (can effectively check records of different materials, such as tables and CRF hospital records), all the original signature of patients' informed consent, all CRF table, the release of detailed records, etc. After the project passes the appraisal and acceptance, all research data will be transferred to the scientific research management office of the project responsible institution, and kept for 5 years after the end of the research. 3. Way of data reporting Each clinical trial center shall, upon completion of at least 5 copies of the CRF, promptly send it to the data manager through the clinical inspector for the purpose of establishing the appropriate database. All data will be double-entered using computer software to prepare the data entry program. The data administrator ensures that the CFR table data is completely and truly entered into the computer. 4. Provisions for data verification After blind review of the data and the conclusion that the established database is correct, the data will be locked by the main researchers and statistical analysts. Locked data files are not allowed to change. The database will be handed over to the statistical analyst for statistical analysis according to the requirements of the statistical plan. Data question and answer the regulation The data sheets in question are forwarded to the investigator by the clinical inspector for data review, and the investigator should reply and return as soon as possible.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2019-11-30
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