“通督调神益智”康复方案对脑卒中后轻度认知障碍的循证评价

注册号:

Registration number:

ITMCTR2024000461

最近更新日期:

Date of Last Refreshed on:

2024-09-21

注册时间:

Date of Registration:

2024-09-21

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

“通督调神益智”康复方案对脑卒中后轻度认知障碍的循证评价

Public title:

Evidence based evaluation of the "Tongdu Tiaoshen Yizhi" rehabilitation program for mild cognitive impairment after stroke

注册题目简写:

English Acronym:

研究课题的正式科学名称:

“通督调神益智”康复方案对脑卒中后轻度认知障碍的循证评价

Scientific title:

Evidence based evaluation of the "Tongdu Tiaoshen Yizhi" rehabilitation program for mild cognitive impairment after stroke

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:

申请注册联系人:

王秋月

研究负责人:

吴东宇

Applicant:

Qiuyue Wang

Study leader:

Dongyu Wu

申请注册联系人电话:

Applicant telephone:

13167371095

研究负责人电话:

Study leader's telephone:

13911202927

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:

wangqiuyue27@126.com

研究负责人电子邮件:

Study leader's E-mail:

wudongyu73@hotmail.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:

北京市朝阳区中环南路6号

研究负责人通讯地址:

北京市朝阳区中环南路6号

Applicant address:

No. 6 Zhonghuan South Road Chaoyang District Beijing

Study leader's address:

No. 6 Zhonghuan South Road Chaoyang District Beijing

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:

中国中医科学院望京医院

Applicant's institution:

Wangjing Hospital, China Academy of Chinese Medical Sciences

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:

WJEC-KT-2024-040-P002

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

中国中医科学院望京医院伦理委员会

Name of the ethic committee:

Wangjing Hospital, China Academy of Chinese Medical Sciences ethics committee

伦理委员会批准日期:

Date of approved by ethic committee:

2024/6/12 0:00:00

伦理委员会联系人:

王浩

Contact Name of the ethic committee:

Hao Wang

伦理委员会联系地址:

北京市朝阳区中环南路6号

Contact Address of the ethic committee:

No.6 Zhonghuan South Road Chaoyang District

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-84739681

伦理委员会联系人邮箱:

Contact email of the ethic committee:

wjyyec@126.com

研究实施负责(组长)单位:

中国中医科学院望京医院

Primary sponsor:

Wangjing Hospital, China Academy of Chinese Medical Sciences

研究实施负责(组长)单位地址:

北京市朝阳区中环南路6号

Primary sponsor's address:

No.6 Zhonghuan South Road Chaoyang Distric Beijing

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京市

市(区县):

朝阳区

Country:

China

Province:

Beijing

City:

Chaoyang District

单位(医院):

中医科学院望京医院

具体地址:

北京市朝阳区中环南路6号

Institution
hospital:

Wangjing Hospital, China Academy of Chinese Medical Sciences

Address:

No.6 Zhonghuan South Road, Chaoyang District

经费或物资来源:

中国中医科学院望京医院高水平中医医院建设项目 中医药临床循证研究专项

Source(s) of funding:

High level Traditional Chinese Medicine Hospital Construction Project of Wangjing Hospital, Chinese Academy of Chinese Medical Sciences Clinical Evidence based Research Special Project for Traditional Chinese Medicine

研究疾病:

老年性痴呆、血管性痴呆

研究疾病代码:

Target disease:

Alzheimer disease,Vascular dementia

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:

其它

Others

研究目的:

运用针刺联合健脑益智方的“通督调神益智”康复方案治疗脑卒中后轻度认知障碍,明确针药联合的作用规律、适宜时机;通过中医四诊的量化与认知障碍量表和神经电生理评估有机结合,阐明其作用机制;优化本病的中医康复方案形成高质量循证证据。

Objectives of Study:

The rehabilitation program of "Tongdu Tiaoshen Yizhi" using acupuncture combined with brain strengthening and intelligence enhancing formula is used to treat mild cognitive impairment after stroke, and the rules of action and appropriate timing of the combination of acupuncture and medicine are clarified; By combining the quantification of traditional Chinese medicine's four diagnostic methods with cognitive impairment scales and neuroelectrophysiological assessments, we aim to elucidate its mechanism of action; Optimize the traditional Chinese medicine rehabilitation plan for this disease to form high-quality evidence-based evidence.

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)脑梗死发病6个月内;(2)神经心理学测验证实存在认知损害,即1个 及以上认知域的确定损害或2个及以上认知域的临界损害,不符合痴呆诊断标 准。蒙特利尔认知评估量表(MoCA)<26;简易智能精神状态量表(MMSE): 文盲(未受教育)>17分,小学(教育年限≤6年)>20分,中学以上(教育 年限>6年)>24分;(3)中医诊断符合血管性痴呆中医辨证量表证中的虚损 瘀毒证型;(4)年龄在18~75 岁;(5)日常生活基本自理。Barthel指数≥60 分;(6)患者或家属签署知情同意书,配合治疗者。

Inclusion criteria

(1) Within 6 months of onset of cerebral infarction; (2) Neuropsychological tests have confirmed the existence of cognitive impairment, which refers to definite impairment in one or more cognitive domains or critical impairment in two or more cognitive domains, and does not meet the diagnostic criteria for dementia. Montreal Cognitive Assessment Scale (MoCA)<26; Mini Mental State Examination (MMSE): Illiteracy (uneducated)>17 points, primary school (education years ≤ 6 years)>20 points, secondary school or above (education years>6 years)>24 points; (3) The traditional Chinese medicine diagnosis conforms to the deficiency, damage, stasis, and toxin syndrome type in the TCM syndrome differentiation scale for vascular dementia; (4) Age between 18 and 75 years old; (5) Basic self-care in daily life. Barthel index ≥ 60 points; (6) The patient or family member signs an informed consent form and cooperates with the treatment provider.

排除标准:

(1)本次脑梗死发病前存在认知障碍者; (2)既往曾服用胆碱酯酶抑制剂、胞磷胆碱钠等可改善认知的药物或接受改善认知的针刺治疗者;(3)因精神疾患、认知或情绪障碍无法完成本研究者;(4)有严重心脏、消化、泌尿系统等其他威胁生命的严重疾病;(5)患者无长期共同生活或照料者;(6)妊娠、计划妊娠或哺乳期妇女;(7)近1个月参加与针刺或认知障碍相关临床试验者。

Exclusion criteria:

(1) Individuals with cognitive impairment prior to the onset of this cerebral infarction; (2) Individuals who have previously taken cognitive improving drugs such as acetylcholinesterase inhibitors and sodium phosphatidylcholine, or received acupuncture treatment with version 10, dated May 29, 2024 to improve cognition; (3) Individuals who are unable to complete this study due to mental illness, cognitive or emotional disorders; (4) Serious heart, digestive, urinary system and other life-threatening diseases; (5) The patient does not have long-term cohabitation or caregivers; (6) Pregnant, planned pregnant or lactating women; (7) Participants in clinical trials related to acupuncture or cognitive impairment in the past month.

研究实施时间:

Study execute time:

From 2024-06-01

To      2025-12-31

征募观察对象时间:

Recruiting time:

From 2024-12-01

To      2025-09-01

干预措施:

Interventions:

组别:

D组

样本量:

62

Group:

Group D

Sample size:

干预措施:

健脑益智方+针刺+常规认知训练

干预措施代码:

Intervention:

Brain strengthening and intelligence enhancing formula+acupuncture+routine cognitive training

Intervention code:

组别:

C组

样本量:

62

Group:

Group C

Sample size:

干预措施:

健脑益智方+假针刺+常规认知训练

干预措施代码:

Intervention:

Brain strengthening and intelligence enhancing formula+sham acupuncture+routine cognitive training

Intervention code:

组别:

A组

样本量:

62

Group:

Group A

Sample size:

干预措施:

中药安慰剂+假针刺+常规认知训练

干预措施代码:

Intervention:

Chinese herbal placebo+sham acupuncture+routine cognitive training

Intervention code:

组别:

B组

样本量:

62

Group:

Group B

Sample size:

干预措施:

中药安慰剂+针刺+常规认知训练

干预措施代码:

Intervention:

Chinese herbal placebo+acupuncture+routine cognitive training

Intervention code:

样本总量 Total sample size : 248

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

beijing

City:

单位(医院):

中医科学院望京医院

单位级别:

三级甲等

Institution/hospital:

Wangjing Hospital, China Academy of Chinese Medical Sciences

Level of the institution:

Level of first-class hospital

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

beijing

City:

单位(医院):

北京市平谷区医院

单位级别:

三级甲等

Institution/hospital:

Beijing Pinggu District Hospital

Level of the institution:

Level of first-class hospital

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

beijing

City:

单位(医院):

北京市大兴区中西医结合医院

单位级别:

三级医院

Institution/hospital:

Beijing Daxing District Integrated Traditional Chinese and Western Medicine Hospital

Level of the institution:

Third level hospital

国家:

中国

省(直辖市):

天津

市(区县):

Country:

China

Province:

tianjin

City:

单位(医院):

天津市武清区中医医院

单位级别:

三级甲等

Institution/hospital:

Tianjin Wuqing District Traditional Chinese Medicine Hospital

Level of the institution:

Level of first-class hospital

测量指标:

Outcomes:

指标中文名:

脑电图

指标类型:

主要指标

Outcome:

electroencephalogram

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿常规

指标类型:

副作用指标

Outcome:

urinalysis

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床痴呆评定量表

指标类型:

主要指标

Outcome:

Clinical Dementia Rating 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:

阿尔茨海默病评定量表-认知部分

指标类型:

主要指标

Outcome:

Alzheimer's Disease Rating Scale - Cognitive Section

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝功能

指标类型:

副作用指标

Outcome:

liver function

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医症候量表

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:

神经精神症状问卷

指标类型:

次要指标

Outcome:

Neuropsychiatric Symptom 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:

简易智能精神状态检查量表

指标类型:

主要指标

Outcome:

Mini-mental state examination

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

便常规

指标类型:

副作用指标

Outcome:

As usual

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

诱发电位

指标类型:

主要指标

Outcome:

event-related potential

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:

血常规

指标类型:

副作用指标

Outcome:

routine blood test

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量量表

指标类型:

次要指标

Outcome:

Quality of Life 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:

功能活动问卷

指标类型:

次要指标

Outcome:

Functional Activity 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:

肾功能

指标类型:

副作用指标

Outcome:

renal function

Type:

Adverse events

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 18
Min age years
最大 75
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):

本试验采用随机方法由中国中医科学院望京医院GCP研究人员 操作,采用SAS 9.4统计软件生成随机数字和相应的统计序列。随机序列由专门的技术人 员负责保管,并按此序列1:1:1:1将患者分配为A、B、C、D四组。

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

This experiment was conducted using a random method by GCP researchers from Wangjing Hospital, Chinese Academy of Traditional Chinese Medicine. SAS 9.4 statistical software was used to generate random numbers and corresponding statistical sequences. The random sequence is managed by specialized technicians, and patients are assigned to four groups A, B, C, and D according to this sequence 1:1:1:1.

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

No

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):

No

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:

病历记录表

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

Case Record Form

数据管理委员会:

Data Managemen Committee:

Yes

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):

国际传统医学临床试验注册平台 京ICP备07032215号-5 提示:推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统