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基于雄激素受体基因研究脾虚湿热证抑郁症伴脂溢性脱发的发生机制
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注册号:

Registration number:

ChiCTR2000039771 

最近更新日期:

Date of Last Refreshed on:

2020-11-08 

注册时间:

Date of Registration:

2020-11-08 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于雄激素受体基因研究脾虚湿热证抑郁症伴脂溢性脱发的发生机制 

Public title:

Based on Androgen Receptor Gene to Study the Mechanism of Spleen Deficiency Damp-heat Syndrome Depression with Seborrheic Alopecia 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于雄激素受体基因研究脾虚湿热证抑郁症伴脂溢性脱发的发生机制 

Scientific title:

Based on Androgen Receptor Gene to Study the Mechanism of Spleen Deficiency Damp-heat Syndrome Depression with Seborrheic Alopecia 

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:

刘兰英 

研究负责人:

刘兰英 

Applicant:

Lanying Liu 

Study leader:

Lanying Liu 

申请注册联系人电话:

Applicant telephone:

+86 13516816012 

研究负责人电话:

Study leader's telephone:

+86 13516816012 

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:

balindaliu@163.com 

研究负责人电子邮件:

Study leader's E-mail:

balindaliu@163.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:

浙江省杭州市西湖区古翠路234号 

研究负责人通讯地址:

浙江省杭州市西湖区古翠路234号 

Applicant address:

234 Gucui Road, Xihu District, Hangzhou, Zhejiang, China  

Study leader's address:

234 Gucui Road, Xihu 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:

浙江省立同德医院 

Applicant's institution:

Tongde Hospital of zhejiang province 

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】062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:

Ethics Committee of Tongde Hospital of zhejiang province  

伦理委员会批准日期:

Date of approved by ethic committee:

2020-10-23 

伦理委员会联系人:

王扬 

Contact Name of the ethic committee:

Wang Yang 

伦理委员会联系地址:

杭州市西湖区文一路310号中竹大厦9010伦理委员会办公室 

Contact Address of the ethic committee:

Ethics Committee Office,Room 9010, Zhongzhu Building, 310 Wenyi Road, Xihu District, Hangzhou, Zhejiang, China  

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0571 89975971 

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:

浙江省立同德医院 

Primary sponsor:

Tongde Hospital of zhejiang province 

研究实施负责(组长)单位地址:

浙江省立同德医院 

Primary sponsor's address:

Tongde Hospital of zhejiang province 

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

市(区县):

杭州

Country:

China

Province:

zhejiang

City:

Hangzhou

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:

Tongde Hospital of zhejiang province

Address:

234 Gucui Road, Xihu District, Hangzhou, Zhejiang, China

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:

Pilot project of cooperation between Chinese and Western medicine for national major and difficult diseases  

研究疾病:

抑郁 

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:

基于雄激素受体基因研究脾虚湿热证抑郁症伴脂溢性脱发的发生机制  

Objectives of Study:

Based on Androgen Receptor Gene to Study the Mechanism of Spleen Deficiency Damp-heat Syndrome Depression with Seborrheic Alopecia 

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:

1.符合美国精神疾病诊断统计手段第5版(DSM-V)抑郁发作诊断标准;2.符合《中国临床皮肤病学》中脂溢性脱发的诊断标准;3.符合中医证型为脾虚湿热型;4.汉密尔顿抑郁量表(HAMD-17)评分≥17分;5.年龄18—65周岁(包含18、65周岁人群),性别、文化、经济等不限;6.患者意识清楚,并能配合相关治疗、测试及检验,自愿签署知情同意书并且能够依从研究方案;7.近一周内未服用与疾病相关药物; 

Inclusion criteria

1. Comply with the diagnostic criteria for depressive episodes in the United States Diagnostic Statistical Methods for Mental Disorders (DSM-V); 2. Comply with the diagnostic criteria for seborrheic alopecia in "Chinese Clinical Dermatology"; 3. Comply with the TCM syndrome type of spleen deficiency and damp-heat Type; 4. Hamilton Depression Rating Scale (HAMD-17) score ≥ 17 points; 5. Age 18-65 (including people aged 18 and 65), gender, culture, economy, etc. are not limited; 6. The patient has a clear consciousness, and can cooperate with relevant treatment, testing and inspection, voluntarily sign an informed consent form and be able to comply with the research plan; 7. Have not taken disease-related drugs in the past week; 

排除标准:

1.不符合纳入标准者;2.严重自残自杀倾向者;3.哺乳期、妊娠或有可能在研究期间怀孕的女性;4.有严重心、肝、肾、血液、肿瘤、免疫、癫痫等重大疾病,有其他精神疾病,有脑器质性疾病,有严重的烟酒及其他精神活性药物依赖史;5.其他类型脱发:如甲状腺功能低下或亢进、甲状旁腺或垂体功能低下、性腺功能减退症等内分泌脱发;6.无知情同意。 

Exclusion criteria:

1. Those who do not meet the inclusion criteria; 2. Those with serious self-harm and suicidal tendencies; 3. Women who are breastfeeding, pregnant or may become pregnant during the study period; 4. Have serious heart, liver, kidney, blood, tumor, immunity, epilepsy and other major diseases, have other mental diseases, have brain organic diseases, and have serious History of dependence on tobacco, alcohol and other psychoactive drugs; 5. Other types of hair loss: such as hypothyroidism or hyperthyroidism, hypoparathyroid or pituitary hypofunction, hypogonadism and other endocrine alopecia; 6. No informed consent. 

研究实施时间:

Study execute time:

From2020-11-20To 2023-11-20 

征募观察对象时间:

Recruiting time:

From2020-11-20To 2023-11-20 

干预措施:

Interventions:

组别:

研究组

样本量:

90

Group:

Case series

Sample size:

干预措施:

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 

市(区县):

杭州 

Country:

China 

Province:

zhejiang 

City:

Hangzhou 

单位(医院):

浙江省立同德医院 

单位级别:

三级甲等 

Institution
hospital:

Tongde Hospital of Zhejiang province  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

汉密尔顿抑郁量表

指标类型:

主要指标 

Outcome:

Hamilton rating scale for depression

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

汉密尔顿焦虑量表

指标类型:

主要指标 

Outcome:

Hamilton Anxiety Scale

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

皮肤病生活质量指数

指标类型:

主要指标 

Outcome:

Dermatology Life Quality Index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脂溢性脱发问卷

指标类型:

主要指标 

Outcome:

Seborrheic Alopecia Questionnaire

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:

外周血

组织:

Sample Name:

Peripheral Blood

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):

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

No

盲法:

Blinding:

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):

不共享

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

No

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:

No

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

No

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-11-08
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