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针灸治疗原发性高血压病(1级,低危)的临床研究
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注册号:

Registration number:

ChiCTR1800015591 

最近更新日期:

Date of Last Refreshed on:

2018-04-13 

注册时间:

Date of Registration:

2018-04-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

针灸治疗原发性高血压病(1级,低危)的临床研究 

Public title:

Acupuncture therapy for primary hypertension: a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

针灸治疗原发性高血压病(1级,低危)的临床研究 

Scientific title:

Acupuncture therapy for primary hypertension: a randomized controlled trial 

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:

AMCTR-IOR-18000159 

申请注册联系人:

陈昊 

研究负责人:

陈昊 

Applicant:

Hao Chen 

Study leader:

Hao Chen 

申请注册联系人电话:

Applicant telephone:

+86 025-85811657 

研究负责人电话:

Study leader's telephone:

+86 025-85811657 

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:

haotcsgc@163.com 

研究负责人电子邮件:

Study leader's E-mail:

haotcsgc@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:

南京仙林大道138号 

研究负责人通讯地址:

南京仙林大道138号 

Applicant address:

138 Xianlin Avenue, Nanjing, Jiangsu, China 

Study leader's address:

138 Xianlin Avenue, Nanjing, Jiangsu, 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:

南京中医药大学 

Applicant's institution:

Nanjing University of Chinese Medicine 

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:

2017W1124 

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:

南京中医药大学第二附属医院江苏省第二中医院伦理委员会 

Name of the ethic committee:

The Ethics Committee of the Second Affiliated Hospital of Nanjing University of Chinese Medicine/Jiangsu Province Second Chinese Medicine Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-11-28 

伦理委员会联系人:

朱春晖 

Contact Name of the ethic committee:

Chunhui Zhu 

伦理委员会联系地址:

江苏省南京建邺区南湖路23号 

Contact Address of the ethic committee:

23 Nanhu Road, Nanjing, 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:

南京中医药大学 

Primary sponsor:

Nanjing University of Chinese Medicine 

研究实施负责(组长)单位地址:

南京仙林大道138号 

Primary sponsor's address:

138 Xianlin Avenue, Nanjing, Jiangsu, 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):

江苏

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

南京中医药大学

具体地址:

南京仙林大道138号

Institution
hospital:

Nanjing University of Chinese Medicine

Address:

138 Xianlin Avenue, Nanjing, Jiangsu, China

国家:

中国

省(直辖市):

江苏

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

The Second Affiliated Hospital of Nanjing University of Chinese Medicine/Jiangsu Province Second Chinese Medicine Hospital

具体地址:

江苏省南京建邺区南湖路23号

Institution
hospital:

The Second Affiliated Hospital of Nanjing University of Chinese Medicine/Jiangsu Province Second Chinese Medicine Hospital

Address:

23 Nanhu Road, Nanjing, China

经费或物资来源:

南京中医药大学针灸学科 

Source(s) of funding:

Acupuncture subject of Nanjing University of Chinese Medicine 

研究疾病:

原发性高血压病(I级,低危) 

Target disease:

Primary hypertension ( Grade I , low risk) 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

评估针刺联合揿针治疗原发性高血压病(1级低危)的安全性级有效性 

Objectives of Study:

To assess the effect and safety of acupuncture combined with thumb-tack needle therapy for primary hypertension ( Grade I, low risk) 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)根据指南诊断为I级低风险高血压; (2)患者近2周内未做过针灸相关治疗; (3)初诊为高血压或虽经高血压治疗,血压仍未达标; (4)明确研究内容,并自愿参加研究,签订知情同意书; (5)18-70岁之间 

Inclusion criteria

(1) Diagnosed with hypertension (Grade 1, low risk); (2) No acupuncture treatment within two weeks; (3) The initial diagnosis is hypertension or although hypertension treatment, blood pressure is still not up to the standard; (4) Patients voluntarily participate in the study and sign informed consent; (5) Between 18 and 70 years old. 

排除标准:

(1)继发性高血压患者 (2)无行为自主能力或合并急性心衰、脑出血等严重心脑血管疾病; (3)怀孕及哺乳期妇女; (4)肿瘤患者及其他经心内科专家认定不适合参加试验者; 

Exclusion criteria:

1. Secondary hypertension; 2. Disability in self-consciousness or with acute heart failure, cerebral hemorrhage and other serious cardiovascular diseases; 3. Pregnant and lactating women; 4. Cancer patients or unfit for the research evaluated by the cardiologists. 

研究实施时间:

Study execute time:

From2018-05-01To 2020-05-01 

干预措施:

Interventions:

组别:

针灸组

样本量:

41

Group:

Acupuncture therapy group

Sample size:

干预措施:

Acupuncture plus thumb-tack needle therapy

干预措施代码:

Intervention:

Acupuncture

Intervention code:

组别:

安慰针灸组

样本量:

41

Group:

Sham acupuncture group

Sample size:

干预措施:

安慰针刺

干预措施代码:

Intervention:

Sham acupuncture

Intervention code:

组别:

常规治疗组

样本量:

41

Group:

Conventional therapy

Sample size:

干预措施:

生活调控

干预措施代码:

Intervention:

Life modification

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

南京中医药大学第二附属医院/江苏省第二中医院 

单位级别:

三级甲等中医院 

Institution
hospital:

The Second Affiliated Hospital of Nanjing University of Chinese Medicine/Jiangsu Province Second Chinese Medicine Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

血压

指标类型:

主要指标 

Outcome:

blood pressure

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

有效率

指标类型:

主要指标 

Outcome:

response rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

1年后心血管事件发生率

指标类型:

次要指标 

Outcome:

Incidence of cardiovascular after 1 year

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良反应发生率

指标类型:

副作用指标 

Outcome:

adverse effect

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗依从性

指标类型:

副作用指标 

Outcome:

treatment compliance

Type:

Adverse events 

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:

None

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 70 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):

专人使用SPSS产生随机序列。

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

An independent investigator generate the random sequence by SPSS.

盲法:

Blinding:

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:

试验完成后6个月内公开/Within six months after the trial complete

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):

试验完成后6个月内在ResMan平台公开试验数据

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

Within six months after the trial complete, we will share all the data on ResMan platform

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:

CRF表格记录原始数据,EpiDate建立电子数据库,并由2位研究者交叉核对录入电子数据库

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

Original data will be recorded by CRF. Electro-database will be created by Epidata. All the records will be double crosscheck and kept in the Electro-database.

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2018-04-10
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