关于针刺后皮肤色素沉着形成的调查研究

注册号:

Registration number:

AMCTR-OOC-17000109 

注册号获得时间:

Date of releasing the registration number:

2017/9/21 15:03:28 

注册号状态:

补注册  

Registration Status:

1008002 Retrospective registration  

注册题目:

关于针刺后皮肤色素沉着形成的调查研究 

Public title:

Research on the formation of chromatosis after acupuncture 

研究课题的正式科学名称:

关于针刺后皮肤色素沉着形成的调查研究 

Scientific title:

Research on the formation of chromatosis after acupuncture 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

赵雨薇 

研究负责人:

赵雨薇 

Applicant:

Zhao Yuwei 

Study leader:

Zhao Yuwei 

申请注册联系人电话:

Applicant telephone:

13651060969 

研究负责人电话:

Study leader's telephone:

13651060969 

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:

506113296@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

506113296@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:

中国中医科学院广安门医院 

研究负责人通讯地址:

中国中医科学院广安门医院 

Applicant address:

Guang'anmen Hospital,China Academy of Chinese Medical Sciences 

Study leader's address:

Guang'anmen Hospital,China Academy of Chinese Medical Sciences 

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:

中国中医科学院广安门医院 

Applicant's institution:

Guang'anmen Hospital,China Academy of Chinese Medical Sciences 

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:

2017-006-KY 

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:

中国中医科学院广安门医院伦理委员会 

Name of the ethic committee:

Research Ethics Committee of Guanganmen Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-03-06 

研究实施负责(组长)单位:

中国中医科学院广安门医院 

Primary sponsor:

Guang'anmen Hospital,China Academy of Chinese Medical Sciences 

研究实施负责(组长)单位地址:

北京市西城区北线阁5号 

Primary sponsor's address:

No.5,Beixian pavilion, Xicheng 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

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院广安门医院

具体地址:

北京市西城区北线阁5号

Institution
hospital:

Guang'anmen Hospital,China Academy of Chinese Medical Sciences

Address:

No.5, beixian pavilion, xicheng district, Beijing, China

经费或物资来源:

无 

Source(s) of funding:

None 

研究疾病:

色素沉着 

Target disease:

chromatosis 

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:

探索针刺后皮肤色素沉着形成的相关影响因素 

Objectives of Study:

The study aims to survey the influence factors about the formation of chromatosis after acupuncture 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

1.接受针刺治疗的患者; 2.意识清醒,无精神障碍,无严重心、肝、肾脏疾病的招募患者; 同时符合以上2项者方可纳入本研究。 

Inclusion criteria

1.Patients who are under acupuncture treatment; 2.Patients who are conscious , have no mental disorders and have no severe heart,liver or kidney disease Those who meet all of the above two conditions could be involved in this trial. 

排除标准:

1.认知障碍,不能理解量表评价内容的患者; 2.有严重心、肝、肾脏疾病的患者; 凡符合上述任意1项者,予以排除。 

Exclusion criteria:

1.Patients who are cognitive disorders, or have problems to understand the questionnaire content; 2.Patients who have severe heart,liver or kidney disease; Those who conform to any of the above mentioned should be excluded. 

研究实施时间:

Study execute time:

From2017-01-01To 2017-12-31 

干预措施:

Interventions:

组别:

针刺

样本量:

200

Group:

acupuncture

Sample size:

干预措施:

针刺

干预措施代码:

1

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):

中国中医科学院广安门医院 

单位级别:

三级医院 

Institution
hospital:

Guang'anmen Hospital,China Academy of Chinese Medical Sciences  

Level of the institution:

3A hospital 

测量指标:

Outcomes:

指标中文名:

色素沉着

指标类型:

主要指标 

Outcome:

chromatosis

Type:

Primary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

none

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 3 years
最大 Max age 90 years

随机方法(请说明由何人用什么方法产生随机序列):

性别:

男女均可

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

none

Gender:

Both

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):

www.acmctr.org

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

www.acmctr.org

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):

www.acmctr.org

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

www.acmctr.org

创建人:

Creater Name:

 2017-09-18
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