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饮食嗜甜与抑郁症发作的相关性及作用机制的研究
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注册号:

Registration number:

ChiCTR2000034380 

最近更新日期:

Date of Last Refreshed on:

2020-07-04 

注册时间:

Date of Registration:

2020-07-04 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

饮食嗜甜与抑郁症发作的相关性及作用机制的研究 

Public title:

A study on the correlation and mechanism between sweet-preferred diet and depression bouts 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

饮食嗜甜与抑郁症发作的相关性及作用机制的研究 

Scientific title:

A study on the correlation and mechanism between sweet-preferred diet and depression bouts 

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:

肖彬彬 

研究负责人:

肖彬彬 

Applicant:

Xiao Binbin 

Study leader:

Xiao Binbin 

申请注册联系人电话:

Applicant telephone:

+86 17826866849 

研究负责人电话:

Study leader's telephone:

+86 17826866849 

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:

768929137@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

768929137@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:

浙江省杭州市滨江区浙江中医药大学滨文路548号 

研究负责人通讯地址:

浙江省杭州市滨江区滨文路548号 

Applicant address:

548 Binwen Road, Binjiang District, Hangzhou, Zhejiang, China 

Study leader's address:

548 Binwen Road, Binjiang District, Hangzhou, Zhejiang, 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:

浙江中医药大学 

Applicant's institution:

Zhejiang Chinese 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:

浙同德快审字第 [2020]042号 

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:

浙江省立同德医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Tongde Hospital of Zhejiang Province 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-06-12 

伦理委员会联系人:

王扬 

Contact Name of the ethic committee:

Yang Wang 

伦理委员会联系地址:

浙江省立同德医院 

Contact Address of the ethic committee:

Medical Ethics Committee of Tongde Hospital  

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:

浙江中医药大学 

Primary sponsor:

Zhejiang University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

浙江省杭州市滨江区浙江中医药大学滨文路548号 

Primary sponsor's address:

548 Binwen Road, Binjiang District, Hangzhou, Zhejiang, 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):

浙江省

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

浙江省立同德医院

具体地址:

浙江省杭州市西湖区古翠路234号

Institution
hospital:

Medical Ethics Committee of Tongde Hospital

Address:

234 Gucui Road, Xihu District, Hangzhou

经费或物资来源:

国家重大疑难疾病中西医协作试点项目 

Source(s) of funding:

National Pilot Project on Major and Difficult Diseases of Chinese and Western Medicine 

研究疾病:

抑郁症 

Target disease:

Depression 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

研究饮食嗜甜与抑郁症发作的相关性及作用机制 

Objectives of Study:

A study on the correlation and mechanism between sweet-preferred diet and depression bouts 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

符合DSM-Ⅴ抑郁发作诊断标准,同时,汉密尔顿抑郁量表(Hamilton rating scale for depression ,HAMD)24项评分>17分,性别不限,年龄18-65 岁. 

Inclusion criteria

It meets the DSM-Ⅴ diagnostic criteria for depressive episodes. At the same time, the Hamilton Rating Scale for Depression (HAMD) score of 24 items is >17 points, aged 18-65 years old. 

排除标准:

存在严重心、肝、肾疾病,存在脑器质性疾病,存在严重心血管疾病、肿瘤、血液病史、风湿病、营养不良及神经系统变性等疾病;继发于其他精神疾病或躯体疾病的抑郁发作。妊娠妇女;无知情同意。 

Exclusion criteria:

There are serious heart, liver and kidney diseases, there are brain organic diseases, there are serious cardiovascular diseases, tumors, blood history, rheumatism, malnutrition and nervous system degeneration, etc.; depression secondary to other mental or physical diseases attack. Pregnant women; no informed consent. 

研究实施时间:

Study execute time:

From2020-12-01To 2022-03-01 

征募观察对象时间:

Recruiting time:

From2020-12-01To 2021-12-01 

干预措施:

Interventions:

组别:

Case series

样本量:

500

Group:

Case series

Sample size:

干预措施:

no

干预措施代码:

Intervention:

no

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江省立同德医院 

单位级别:

三级甲等 

Institution
hospital:

Medical Ethics Committee of Tongde Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

汉密哈顿抑郁症评分

指标类型:

主要指标 

Outcome:

Hamilton Hatton Depression Score

Type:

Primary indicator 

测量时间点:

任意时间

测量方法:

两名中医师评分取平均值

Measure time point of outcome:

All Time

Measure method:

The average score of two Chinese medicine practitioners

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

no

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 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):

N/A

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

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

邮件索取

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

Request by mail

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:

excel,spss 20 等

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

excel, spss 20, etc.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-07-04
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