今天是:2020-08-03 星期一

王晖医师:该研究尚未获得伦理委员会批准,请于批准后再开始纳入参试者,并与我们联系上传批件。 慢性心衰患者的中医证素及组合分布特点的研究
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注册号:

Registration number:

ChiCTR2000034555 

最近更新日期:

Date of Last Refreshed on:

2020-07-11 

注册时间:

Date of Registration:

2020-07-09 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

王晖医师:该研究尚未获得伦理委员会批准,请于批准后再开始纳入参试者,并与我们联系上传批件。 慢性心衰患者的中医证素及组合分布特点的研究 

Public title:

Combination and distribution characteristics of syndromes related to Traditional Chinese medicine in patients with chronic heart failure: protocol for a clinical study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

慢性心衰患者的中医证素及组合分布特点的研究 

Scientific title:

Combination and distribution characteristics of syndromes related to Traditional Chinese medicine in patients with chronic heart failure: protocol for a clinical study 

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:

ChiMCTR2000003479 

申请注册联系人:

王晖 

研究负责人:

王晖 

Applicant:

Hui Wang 

Study leader:

Hui Wang 

申请注册联系人电话:

Applicant telephone:

+86 0315-3045120 

研究负责人电话:

Study leader's telephone:

+86 0315-3045120 

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:

vxzxb7@163.com 

研究负责人电子邮件:

Study leader's E-mail:

vxzxb7@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:

中国河北省唐山市开平区矿南路10号 

研究负责人通讯地址:

中国河北省唐山市开平区矿南路10号 

Applicant address:

10 Mining Road South, Kaiping District, Tangshan, Hebei, China 

Study leader's address:

10 Mining Road South, Kaiping District, Tangshan, Hebei, 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:

河北省唐山市开滦马家沟医院 

Applicant's institution:

Kailuan Majiagou Hospital, Tangshan, Hebei 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

河北省唐山市开滦马家沟医院 

Primary sponsor:

Kailuan Majiagou Hospital, Tangshan, Hebei 

研究实施负责(组长)单位地址:

中国河北省唐山市开平区矿南路10号开滦马家沟医院 

Primary sponsor's address:

10 Mining Road South, Kaiping District, Tangshan, Hebei, 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):

河北

市(区县):

唐山

Country:

China

Province:

Hebei

City:

Tangshan

单位(医院):

河北省唐山市开滦马家沟医院

具体地址:

开平区矿南路10号开滦马家沟医院

Institution
hospital:

Kailuan Majiagou Hospital, Tangshan, Hebei

Address:

10 Mining Road South, Kaiping District

经费或物资来源:

河北省中医药管理局科研计划项目 

Source(s) of funding:

Scientific Research Project of Hebei Administration of Traditional Chinese Medicine 

研究疾病:

慢性心衰 

Target disease:

chronic heart failure 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

研究慢性心衰(chronic heart failure, CHF)患者的中医证素及组合分布特点,并分析证素与相关影响因素的关系,探寻本病的证素分布规律、基本病机、证素与客观指标的相关性。 

Objectives of Study:

To study the distribution characteristics of TCM syndromes and combinations of patients with chronic heart failure (CHF), analyze the relationship between syndromes and related influencing factors, and explore the syndromes of this disease Correlation of distribution law, basic pathogenesis, syndromes and objective indicators. 

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)符合西医学CHF诊断标准。 (2) 心功能分级(分级)属于2-4级患者。 (3) 年龄在45-85岁之间。 (4)已自愿签署知情同意书者。 

Inclusion criteria

(1) Comply with the diagnostic standards of Western medicine T2DM and CHF. (2) Cardiac function grading (grading) belongs to 2-4 patients. (3) The age is between 45-85 years old. (4) Those who have voluntarily signed the informed consent. 

排除标准:

(1)有恶性高血压、严重心律失常、急性心肌梗塞、脑血管意外等重症病者。 (2)近期有急性感染、创伤、手术、糖尿病酮症酸中毒、高渗性昏迷者。 (3)合并有脑、肝、肾和造血系统等严重原发性疾病,精神病和认知功能异常患者。 (4)合并有肿瘤及其他脏器功能衰竭者。 

Exclusion criteria:

(1) Patients with severe diseases such as malignant hypertension, severe arrhythmia, acute myocardial infarction, cerebrovascular accident, etc. (2) Patients with acute infection, trauma, surgery, diabetic ketoacidosis, and hyperosmolar coma recently. (3) Patients with severe primary diseases such as brain, liver, kidney and hematopoietic system, mental illness and cognitive dysfunction. (4) Patients with tumor and other organ failure. 

研究实施时间:

Study execute time:

From2021-01-01To 2022-01-31 

征募观察对象时间:

Recruiting time:

From2021-02-01To 2022-01-01 

干预措施:

Interventions:

组别:

case series

样本量:

100

Group:

case series

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河北 

市(区县):

唐山 

Country:

China 

Province:

Hebei 

City:

Tangshan 

单位(医院):

开滦马家沟医院 

单位级别:

二级甲等 

Institution
hospital:

Kailuan Majiagou Hospital, Tangshan, Hebei  

Level of the institution:

Secondary A 

测量指标:

Outcomes:

指标中文名:

中医证候要素

指标类型:

主要指标 

Outcome:

Elements of TCM syndromes

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:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 20 years
最大 Max age 80 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):

不适用

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):

以学术报告的形式

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

In the form of academic reports

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:

我们将应用病例记录表、电子采集和管理系统对研究过程中的数据进行采集和管理

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

We will use case records, electronic collection and management systems to collect and manage data during the research process

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-07-09
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