Research on Exploration and Verification of Head Observation Knowledge Based on Traditional Chinese Medicine Classics

注册号:

Registration number:

ITMCTR2000004170

最近更新日期:

Date of Last Refreshed on:

2020-12-16

注册时间:

Date of Registration:

2020-12-16

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

基于数字化中医经典古籍的头面望诊知识挖掘及探索性验证研究

Public title:

Research on Exploration and Verification of Head Observation Knowledge Based on Traditional Chinese Medicine Classics

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于数字化中医经典古籍的头面望诊知识挖掘及探索性验证研究

Scientific title:

Research on Exploration and Verification of Head Observation Knowledge Based on Traditional Chinese Medicine Classics

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:

ChiCTR2000041017 ; ChiMCTR2000004170

申请注册联系人:

吕宏蓬

研究负责人:

王天芳

Applicant:

Hongpeng Lyu

Study leader:

Tianfang Wang

申请注册联系人电话:

Applicant telephone:

+86 15311429268

研究负责人电话:

Study leader's telephone:

+86 15311429268

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:

2287724510@qq.com

研究负责人电子邮件:

Study leader's E-mail:

2287724510@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:

北京市朝阳区北三环东路11号

研究负责人通讯地址:

北京市朝阳区北三环东路11号 北京中医药大学

Applicant address:

11 North Third Ring Road East, Chaoyang District, Beijing, China

Study leader's address:

11 North Third Ring Road East, Chaoyang 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:

北京中医药大学

Applicant's institution:

Beijing University of Traditional Chinese Medicine

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:

2020BZYLL0610

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:

北京中医药大学伦理委员会

Name of the ethic committee:

Ethics Committee of Beijing University of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2020/11/25 0:00:00

伦理委员会联系人:

秦灵灵

Contact Name of the ethic committee:

Lingling Qin

伦理委员会联系地址:

北京市朝阳区北三环东路11号

Contact Address of the ethic committee:

11 North Third Ring Road East, Chaoyang District, Beijing, 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:

北京中医药大学

Primary sponsor:

Beijing University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

北京市朝阳区北三环东路11号

Primary sponsor's address:

11 North Third Ring Road East, Chaoyang 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):

北京中医药大学

具体地址:

朝阳区北三环东路11号

Institution
hospital:

Beijing University of Traditional Chinese Medicine

Address:

11 North Third Ring Road East, Chaoyang District

经费或物资来源:

北京中医药大学2020年基本科研业务费

Source(s) of funding:

Basic scientific research operating expenses in 2020 of Beijing University of Chinese Medicine

研究疾病:

正常人群

研究疾病代码:

Target disease:

The general population

Target disease code:

研究类型:

Study type:

观察性研究

Observational study

研究设计:

Study design:

连续入组

Sequential

研究所处阶段:

Study phase:

其它

Others

研究目的:

初步验证基于头面部望诊的身心健康状态理论辨识模型,丰富和发展中医头面部望理论与方法,为进一步指导临床诊断及“治未病”提供理论依据和方法支撑。

Objectives of Study:

The preliminary verification of the physical and mental health state theory identification model based on cephalic and facial observation enriched and developed the cephalic and facial observation theory and methods of TCM, providing theoretical basis and method support for further guiding clinical diagnosis and "treating diseases without disease".

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)北京地区高校在校学生(本科、硕士、博士),民族为汉族,年龄为18-35岁; (2)面部外观无明显形态改变;双手无明显形态改变; (3)自愿参加本研究,并签署知情同意书; (4)对本研究的意义有正确认识,对研究人员的观察和评价有良好的依从性。

Inclusion criteria

(1) Students (bachelor's degree, master's degree, doctor's degree) from universities in Beijing, whose nationality is Han and their age is 18-35 years old; (2) No obvious morphological changes in facial appearance; No obvious morphological changes were observed in both hands; (3) Participate in this study voluntarily and sign informed consent; (4) Have a correct understanding of the significance of this study, and have good compliance with the observation and evaluation of researchers.

排除标准:

(1)近1个月未填写过相关心理量表者; (2)有明显的身体残疾者(如小儿麻痹后遗症等); (3)面部曾接受过整形手术者;手部曾接受过手术者; (4)刻下患有明显的躯体或心理疾患,或存在身体的不适(如严重的感冒、头痛、痛经、抑郁、焦虑等),无法或不方便接受信息采集者。

Exclusion criteria:

(1) Those who have not filled in the relevant psychological scale in the past 1 month; (2) persons with significant physical disabilities (e.g. poliomyelitis sequelae, etc.); (3) those who have undergone facial plastic surgery; Those who have had surgery on their hands; (4) Persons suffering from obvious physical or psychological diseases, or suffering from physical discomfort (such as severe cold, headache, dysmenorrhea, depression, anxiety, etc.) who are unable or inconvenient to receive information collection.

研究实施时间:

Study execute time:

From 2020-12-21

To      2021-05-31

征募观察对象时间:

Recruiting time:

From 2020-12-21

To      2021-05-31

干预措施:

Interventions:

组别:

横断面无组别

样本量:

800

Group:

There is no group in cross section

Sample size:

干预措施:

观察性研究,无干预措施

干预措施代码:

Intervention:

Observational studies, no interventions

Intervention code:

样本总量 Total sample size : 800

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):

北京中医药大学

单位级别:

朝阳区北三环东路11号

Institution/hospital:

Beijing University of Traditional Chinese Medicine

Level of the institution:

11 North Third Ring Road East, Chaoyang District

测量指标:

Outcomes:

指标中文名:

面部二维和三维图像

指标类型:

主要指标

Outcome:

2d and 3D images of faces.

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:

组织:

Sample Name:

N/A

Tissue:

人体标本去向

其它

说明

Fate of sample 

Others

Note:

征募研究对象情况:

正在进行

Recruiting

年龄范围:

最小 18
Min age years
最大 35
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):

本研究无随机。

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

There was no randomization in this study.

盲法:

N/A

Blinding:

N/A

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):

本研究完成发表论文后可联系联络人共享原始数据

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

After this study finished and relative papers have been published, the contact person can be contacted to share the original data

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:

基本信息表

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

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

No

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