针刺改善乳腺癌患者化疗后认知障碍的推广研究

注册号:

Registration number:

AMCTR-OOO-19000240 

注册号获得时间:

Date of releasing the registration number:

2019/1/2 14:36:58 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

针刺改善乳腺癌患者化疗后认知障碍的推广研究 

Public title:

Promotion Research for Acupuncture Treatment of Cognitive Impairment Associated with Chemotherapy in Breast Cancer Patients 

研究课题的正式科学名称:

针刺改善乳腺癌患者化疗后认知障碍的推广研究 

Scientific title:

Promotion Research for Acupuncture Treatment of Cognitive Impairment Associated with Chemotherapy in Breast Cancer Patients 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

ChiCTR1800020416 

申请注册联系人:

徐晓华 

研究负责人:

徐晓华 

Applicant:

Xiaohua Xu 

Study leader:

Xiaohua Xu 

申请注册联系人电话:

Applicant telephone:

+86 13261598068 

研究负责人电话:

Study leader's telephone:

+86 13261598068 

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:

1600179201@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

1600179201@qq.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:

北京市东城区美术馆后街23号 

研究负责人通讯地址:

北京市东城区美术馆后街23号 

Applicant address:

23 Back Street of Art Gallery, Dongcheng District, Beijing, China 

Study leader's address:

23 Back Street of Art Gallery, Dongcheng District, Beijing, 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:

首都医科大学附属北京中医医院 

Applicant's institution:

Beijing Hospital of Traditional Chinese Medicine,Capital Medical University 

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:

2018BL-029-01 

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:

首都医科大学附属北京中医医院医学伦理委员会 

Name of the ethic committee:

EC of Bei Jing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-06-20 

研究实施负责(组长)单位:

首都医科大学附属北京中医医院 

Primary sponsor:

Beijing Hospital of Traditional Chinese Medicine,Capital Medical University 

研究实施负责(组长)单位地址:

北京市东城区美术馆后街23号 

Primary sponsor's address:

23 Back Street of Art Gallery, Dongcheng District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京中医医院

具体地址:

北京市东城区美术馆后街23号

Institution
hospital:

Beijing Hospital of Traditional Chinese Medicine,Capital Medical University

Address:

23 Back Street of Art Gallery, Dongcheng District, Beijing, China

经费或物资来源:

北京市卫生和计划生育委员会 

Source(s) of funding:

Beijing Municipal Health and Family Planning Commission 

研究疾病:

乳腺癌患者化疗后认知障碍 

Target disease:

Cognitive Impairment Associated with Chemotherapy in Breast Cancer Patients 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

通过自身前后对照,观察针刺治疗乳腺癌化疗相关认知障碍的效果,提高基层医疗机构对乳腺癌化疗相关认知障碍的认识,推广针刺治疗在社区的应用。 

Objectives of Study:

To observe the effect of acupuncture in treating chemotherapy-related cognitive impairment of breast cancer and improve the cognition of chemotherapy-related cognitive impairment in primary medical institutions and the application of acupuncture in community. 

研究设计:

其他 

Study design:

Other 

纳入标准:

1、 25-55岁的乳腺癌化疗后患者; 2、 根据蒙特利尔评估量表(MoCA)诊断为轻度认知障碍者,即评分在21分~26分之间(含21分和26分) ; 3、中医辨证分型属气血失调型。 

Inclusion criteria

1. Breast cancer patients aged 25-55 years after chemotherapy; 2. Patients with mild cognitive impairment diagnosed according to the Montreal Assessment scale (MoCA) are rated between 21 and 26 (including 21 and 26); 3. Syndrome differentiation of TCM belongs to QiXueShiTiao type. 

排除标准:

1、由抑郁、甲状腺疾病、脑外伤、药物或酒精中毒引起的认知损害者; 2、有严重失语、抑郁证、精神疾病者; 3、合并严重心、肝、肺、肾功能损害所致的认知减退及造血系统、内分泌系统严重原发病者; 4、服用可影响认知功能的药物者(如毒麻药、镇静剂等); 5、达到痴呆的诊断标准。 

Exclusion criteria:

1. People with cognitive impairment caused by depression, thyroid disease, brain trauma, drug or alcohol poisoning; 2. People with severe aphasia, depression, mental illness; 3. Patients with cognitive impairment associated with severe heart, liver, lung, and renal dysfunction and severe primary disease of hematopoietic system and endocrine system; 4. Person who takes drugs that affect cognitive function (eg poison, narcotic, tranquilizer, etc.); 5. Meet the diagnostic criteria of dementia. 

研究实施时间:

Study execute time:

From2018-01-01To 2020-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

200

Group:

Case series

Sample size:

干预措施:

针刺

干预措施代码:

Intervention:

acupuncture

Intervention code:

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):

朝阳区金盏第二社区卫生服务中心 

单位级别:

社区卫生服务中心 

Institution
hospital:

Health service centre of The second Community of Jinzhang, Chaoyang District  

Level of the institution:

Community Health Service Center 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

孙河社区卫生服务中心 

单位级别:

社区卫生服务中心 

Institution
hospital:

Health service centre of Sunhe community  

Level of the institution:

Community Health Service Center 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

安贞社区卫生服务中心 

单位级别:

社区卫生服务中心 

Institution
hospital:

Health service centre of Anzhen community  

Level of the institution:

Community Health Service Center 

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 scale

Type:

Primary indicator 

指标中文名:

简易智力状况检查法

指标类型:

次要指标 

Outcome:

Simple intelligence examination method

Type:

Secondary indicator 

指标中文名:

生活质量测定量表

指标类型:

次要指标 

Outcome:

Quality of life measurement scale

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

no

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 0 years
最大 Max age 0 years

随机方法(请说明由何人用什么方法产生随机序列):

N/A

性别:

女性

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

N/A

Gender:

Female

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

科研论文

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

scientific paper

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

病例记录表

The repository and management of the data(Please specify what repository will be used for management of the metadata):

Case Record Form, CRF

创建人:

Creater Name:

 2018-12-29
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