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松龄血脉康治疗低中危高血压的临床疗效评价 ——多中心、随机、双盲双模拟、平行对照临床试验
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注册号:

Registration number:

ChiCTR-IPR-17011383 

最近更新日期:

Date of Last Refreshed on:

2017-05-12 

注册时间:

Date of Registration:

2017-05-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

松龄血脉康治疗低中危高血压的临床疗效评价 ——多中心、随机、双盲双模拟、平行对照临床试验 

Public title:

Effect of Songlingxuemaikang Capsule on patients with hypertension in low and middle risk: a multicenter, randomized, double-blind, parallel controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

松龄血脉康胶囊治疗低中危高血压的临床研究 

Scientific title:

Clinical research of Songlingxuemaikang Capsule on patients with hypertension in low and middle risk  

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:

蒋跃绒 

研究负责人:

史大卓 

Applicant:

Jiang Yuerong 

Study leader:

Shi Dazhuo 

申请注册联系人电话:

Applicant telephone:

+86 13520361309 

研究负责人电话:

Study leader's telephone:

+86 13511072856 

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:

jiang_yuerong@163.com 

研究负责人电子邮件:

Study leader's E-mail:

heartmail@263.net 

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:

北京市海淀区西苑操场1号 

研究负责人通讯地址:

北京市海淀区西苑操场1号 

Applicant address:

1 Xiyuan Caochang, Haidian District, Beijing, China 

Study leader's address:

1 Xiyuan Caochang, Haidian District, Beijing, 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:

中国中医科学院西苑医院 

Applicant's institution:

Xi Yuan Hospital, China Academy of Chinese Medicine Sciences 

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:

2016XL007-2 

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:

中国中医科学院西苑医院伦理委员会 

Name of the ethic committee:

Ethics Committee, Xi Yuan Hospital, China Academy of Chinese Medicine Sciences  

伦理委员会批准日期:

Date of approved by ethic committee:

2016-11-30 

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:

中国中医科学院西苑医院 

Primary sponsor:

Xi Yuan Hospital, China Academy of Chinese Medicine Sciences  

研究实施负责(组长)单位地址:

北京市海淀区西苑操场1号 

Primary sponsor's address:

1 Xiyuan Caochang, Haidian District, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

四川

市(区县):

Country:

China

Province:

Sichuan

City:

单位(医院):

成都康弘药业集团

具体地址:

四川省成都市金牛区蜀西路36号

Institution
hospital:

Kanghong Pharmaceutical

Address:

36 Shuxi Road, Jinniu District, Chengdu, China

经费或物资来源:

中国中医科学院心血管病研究所与康弘药业合作共建基金 

Source(s) of funding:

The institute of Cardiovascular Diseases of the China Academy of Chinese Medical Sciences and Kanghong pharmaceutical cooperation fund 

研究疾病:

高血压 

Target disease:

Hypertention 

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:

上市后药物 

Study phase:

研究目的:

评价松龄血脉康胶囊治疗低中危高血压患者的有效性及安全性。 

Objectives of Study:

This research is aimed to investigate the efficacy and safety of Songlingxuemaikang(SLXMK) Capsule in treament for patients with Hypertension in low and middle 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)符合原发性高血压病诊断标准,高血压分级为1级,危险分层属低危或中危者; (2)过去未服用降压药或未规律服用降压药; (3)年龄20-75岁之间; (4)同意签署知情同意书。 

Inclusion criteria

1. Primary hypertension, grade 1, in low and middle risk; 2. Patients have not taken or not regularly taken antihypertensive drugs; 3. Aged 20 to 75 years old; 4. Patients are informed about the trial and voluntarilysign the consent form. 

排除标准:

(1)患有明显肝脏疾患或ALT、AST高于正常上限; (2)严重的精神病患者、严重的造血系统疾病患者、恶性肿瘤或患者预期寿命少于3年; (3)估计依从性较差、随访可能性差者; (4)妊娠或准备妊娠妇女,哺乳期妇女; (5)近三个月内参加过或正在参加其它临床试验者。 (6)对试验药物可疑或明确过敏者。 (7)过敏体质或对多种药物过敏者。 

Exclusion criteria:

1. Serious liver disease or alanine transaminase(ALT)/aspartate transaminase(AST) values higher than the upper reference limit value; 2. Severe mental illness, serious diseases of the hematopoietic system, malignancy or having a life expectancy less than 3 years; 3. Suspected to be poor compliance or follow-up; 4. Pregnant women or women who are preparing for pregnancy, lactating women; 5. Previous involvement in other clinical trials or participation in other clinical trials within the past3 months; 6. subjects who are known to be allergic to ingredients of the study drug; 7. Allergies or multiple drug allergies. 

研究实施时间:

Study execute time:

From2017-06-01To 2018-06-30 

干预措施:

Interventions:

组别:

治疗组

样本量:

285

Group:

treatment group

Sample size:

干预措施:

松龄血脉康胶囊

干预措施代码:

Intervention:

Songlingxuemaikang Capsule

Intervention code:

组别:

对照组

样本量:

285

Group:

control group

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国中医科学院西苑医院 

单位级别:

三级甲等 

Institution
hospital:

Xi Yuan Hospital, China Academy of Chinese Medicine Sciences  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京市第一中西医结合医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing First Hospital of Integrated Chinese and Western Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

24小时平均血压

指标类型:

主要指标 

Outcome:

24 hours average 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:

白天平均血压

指标类型:

次要指标 

Outcome:

Daytime average blood pressure

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

夜间平均血压

指标类型:

次要指标 

Outcome:

nocturnal average blood pressure

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

夜间平均血压

指标类型:

次要指标 

Outcome:

nocturnal average blood pressure

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血压波动程度

指标类型:

次要指标 

Outcome:

Blood pressure fluctuation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清一氧化氮、内皮素、血管紧张素转化酶、同型半胱氨酸、C-反应蛋白

指标类型:

附加指标 

Outcome:

NO, ET, ACE, HCY, CRP

Type:

Additional 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:

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 20 years
最大 Max age 75 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):

采用分层、区组随机的方法。由中国中医科学院西苑医院临床药理中心采用SAS统计软件,按参加单位的病例分配数及随机比例生成中心编码随机数字表。

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

A stratified blocked randomization is performed by clinical pharmacology center,Xiyuan Hospital, China Academy of Chinese Medicine Sciences using SAS statistical software.

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):

原始数据于试验完成后6个月内公开,可通过联系人邮箱索取。

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

The original data is available within 6 months after completion of the trial and can be taken from the email of the contacts.

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:

本研究采用中国中医科学院西苑医院药物临床试验数据管理系统进行数据管理。

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

This study uses the clinical trial data management system of clinical pharmacology center,Xiyuan Hospital, China Academy of Chinese Medicine Sciences.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-05-12
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