ChiCTR1900027222 版本V1.1 版本创建时间2022/03/07 12:49:17 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR1900027222 

最近更新日期：

Date of Last Refreshed on：

 2022-03-07 12:48:54 

注册时间：

Date of Registration：

 2019-11-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

An East meets West theory of depression: from “Zang Fu” (臟腑) to neuroscience

Public title：

An East meets West theory of depression: from 'Zang Fu' to neuroscience

注册题目简写：

English Acronym：

研究课题的正式科学名称：

An East meets West theory of depression: from “Zang Fu” (臟腑) to neuroscience

Scientific title：

An East meets West theory of depression: from 'Zang Fu' to neuroscience

研究课题代号(代码)：

Study subject ID：

 2020YJS-003-01

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：

Ms Jiajia Ye 

研究负责人：

Prof. Hector Tsang 

Applicant：

Ms Jiajia Ye 

Study leader：

Prof. Hector Tsang 

申请注册联系人电话：

Applicant telephone：

 +852 97997686

研究负责人电话：

Study leader's
telephone：

+852 27666704

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：

 328699151@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 hector.tsang@polyu.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 http://www8.rs.polyu.edu.hk/ncs/research-students/

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 Prof. Hector Tsang's Homepage

申请注册联系人通讯地址：

中国福建福州市鼓楼区湖东支路13号

研究负责人通讯地址：

中國香港特別行政區九龍紅磡育才道11號

Applicant address：

13 Hudong Branch Road, Fuzhou, Fujian, China

Study leader's address：

11 Yucai Road, Hung Hom, Kowloon, Hong Kong SAR, China

申请注册联系人邮政编码：

Applicant postcode：

 350000

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

香港理工大學康復科學系

Applicant's institution：

Department of Rehabilitation Assessment, Rehabilitation Hospital affiliated to Fujian University of Traditional Chinese Medicine; 2. Department of Rehabilitation Sciences, PolyU

研究负责人所在单位：

香港理工大學康復科學系

Affiliation of the Leader：

The Hong Kong Polytechnic 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：

 2020YJS-003-01

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：

福建中医药大学附属康复医院伦理委员会

Name of the ethic committee：

Fujian University of Traditional Chinese Medicine Subsidiary Rehabilitation Hospital Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2020-10-16 00:00:00

伦理委员会联系人：

林艳珊

Contact Name of the ethic committee：

Lin Yanshan

伦理委员会联系地址：

福建中医药大学附属康复医院科教科

Contact Address of the ethic committee：

Research Office, Fujian University of Traditional Chinese Medicine Subsidiary Rehabilitation Hospital, Fujian, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 0591 88529125

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 None

研究实施负责（组长）单位：

香港理工大學康復科學系

Primary sponsor：

Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

研究实施负责（组长）单位地址：

中國香港特別行政區九龍紅磡育才道11號

Primary sponsor's address：

11 Yucai Road, Hung Hom, Kowloon, Hong Kong SAR, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

香港理工大學康復科學系

Source(s) of funding：

Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

研究疾病：

抑郁症  

Target disease：

depression

研究疾病代码：

None

Target disease code：

None

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

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

To bridge the knowledge gap to understand TCM theories of depression using neurophysiological biomarkers  

Objectives of Study：

To bridge the knowledge gap to understand TCM theories of depression using neurophysiological biomarkers

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

Baduanjin is a kind of mind body exercise that is very popular in China. We would like to invite patients with depression to practice Baduanjin regularly with twice a week, 12 weeks under supervision.  

纳入标准：

1. Aged 18-65 years;
2. Gender: females and males;
3. Western diagnosis: Diagnosed to be suffering from current episode of depression by a psychiatrist based on DSM-5 and subject to verification by Structured Clinical Interview for DSM-5 (SCID-5);
4. Baseline score of 12 or higher on the 17-item Hamilton Rating Scale for Depression (HAM-D17) (29);
5. Traditional Chinese medicine diagnosis: Diagnosed to be experienced the syndromes of liver Qi stagnation by International Medicine of Traditional Chinese Medicine;
6. The Montreal Cognitive Assessment (MoCA) of 20 or higher (30, 31);
7. Patients type: Day- and out-patient;
8. Voluntarily agree with the investigation and willing to sign a written informed consent form.

Inclusion criteria

1. Aged 18-65 years;
2. Gender: females and males;
3. Western diagnosis: Diagnosed to be suffering from current episode of depression by a psychiatrist based on DSM-5 and subject to verification by Structured Clinical Interview for DSM-5 (SCID-5);
4. Baseline score of 12 or higher on the 17-item Hamilton Rating Scale for Depression (HAM-D17) (29);
5. Traditional Chinese medicine diagnosis: Diagnosed to be experienced the syndromes of liver Qi stagnation by International Medicine of Traditional Chinese Medicine;
6. The Montreal Cognitive Assessment (MoCA) of 20 or higher (30, 31);
7. Patients type: Day- and out-patient;
8. Voluntarily agree with the investigation and willing to sign a written informed consent form.

排除标准：

1. Primary diagnosis other than depression;
2. Pregnant or lactating women;
3. Have substance abuse or drug dependence;
4. Acute suicidal or violent behavior;
5. Regular practice of Baduanjin or any kinds of mind-body exercise in the past 6 months (29);
6. Are not able to participant in Baduanjin exercise due to mobility problem.

Exclusion criteria：

1. Primary diagnosis other than depression;
2. Pregnant or lactating women;
3. Have substance abuse or drug dependence;
4. Acute suicidal or violent behavior;
5. Regular practice of Baduanjin or any kinds of mind-body exercise in the past 6 months (29);
6. Are not able to participant in Baduanjin exercise due to mobility problem.

研究实施时间：

Study execute time：

从 From 2020-10-16 00:00:00至 To 2021-10-16 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-10-16 00:00:00 至 To 2021-10-16 00:00:00

干预措施：

Interventions：

组别：

Two groups

样本量：

 90

Group：

2 Groups

Sample size：

干预措施：

八段錦

干预措施代码：

Intervention：

Baduanjin

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 福建 

市(区县)：

 福州 

Country：

China

Province：

Fujian

City：

Fuzhou

单位(医院)：

 福建中医药大学附属康复医院 

单位级别：

 三级医院 

Institution
hospital：

Fujian University of Traditional Chinese Medicine Subsidiary Rehabilitation Hospital,

Level of the institution：

Tertiary Hospital

测量指标：

Outcomes：

指标中文名：

Blood levels of ACTH

指标类型：

主要指标

Outcome：

Blood levels of ACTH

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

blood levels of cortisol

指标类型：

主要指标

Outcome：

blood levels of cortisol

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Blood levels of NE

指标类型：

主要指标

Outcome：

Blood levels of NE

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Heart rate variability (HRV)

指标类型：

主要指标

Outcome：

Heart rate variability (HRV)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Liver Qi stagnation

指标类型：

次要指标

Outcome：

Liver Qi stagnation

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

The Hamilton Rating Scale for Depression (HRSD)

指标类型：

次要指标

Outcome：

The Hamilton Rating Scale for Depression (HRSD)

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：

标本中文名：

血液

组织：

Sample Name：

blood

Tissue：

None

人体标本去向

 使用后销毁  

说明

3 months

Fate of sample：

Destruction after use  

Note：

3 months

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 18 岁 years
最大 Max age 65 岁 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）：

we will recruit research associates to randomize the patients by computer software.

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

we will recruit research associates to randomize the patients by computer software.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Open label

Blinding：

Open label

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）：

will share later

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

will share later

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：

will share later

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

will share later

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2019-11-05 21:02:51