今天是:2022-07-07 星期四

藤菔降压片联合缬沙坦/氨氯地平治疗原发性高血压(2级) 肝阳上亢证的随机、双盲、安慰剂对照、多中心临床研究
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注册号:

Registration number:

ChiCTR2000030611 

最近更新日期:

Date of Last Refreshed on:

2021-03-15 

注册时间:

Date of Registration:

2020-03-08 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

藤菔降压片联合缬沙坦/氨氯地平治疗原发性高血压(2级) 肝阳上亢证的随机、双盲、安慰剂对照、多中心临床研究 

Public title:

A multicenter randomized, double-blind, placebo-controlled trial for Teng-Fu Jiang-Ya tablets combined with Valsartan/Amlodipine in the Treatment of primary hypertension (grade 2) with liver yang hyperactivity syndrome 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

藤菔降压片联合缬沙坦/氨氯地平治疗原发性高血压(2级) 肝阳上亢证的随机、双盲、安慰剂对照、多中心临床研究 

Scientific title:

A multicenter randomized, double-blind, placebo-controlled trial for Teng-Fu Jiang-Ya tablets combined with Valsartan/Amlodipine in the Treatment of primary hypertension (grade 2) with liver yang hyperactivity syndrome 

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:

ChiMCTR2000003098 

申请注册联系人:

陈文静 

研究负责人:

李运伦 

Applicant:

Wenjing Chen 

Study leader:

Yunlun Li 

申请注册联系人电话:

Applicant telephone:

+86 13455159979 

研究负责人电话:

Study leader's telephone:

+86 13869102760 

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:

wenjing198412@163.com 

研究负责人电子邮件:

Study leader's E-mail:

li.yunlun@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:

山东省济南市历下区经十路16369号 

研究负责人通讯地址:

山东省济南市历下区经十路16369号 

Applicant address:

16369 Jingshi Road, Lixia District, Ji'nan, Shandong, China 

Study leader's address:

16369 Jingshi Road, Lixia District, Ji'nan, Shandong, 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:

山东中医药大学附属医院 

Applicant's institution:

Affiliated Hospital of Shandong University of Traditional 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:

(2019)伦审第(064)号-KY 

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:

山东中医药大学附属医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Affiliated Hospital of Shandong University of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-01-16 

伦理委员会联系人:

张立娟 

Contact Name of the ethic committee:

Lijuan Zhang 

伦理委员会联系地址:

山东省济南市历下区经十路16369号 

Contact Address of the ethic committee:

16369 Jingshi Road, Lixia District, Ji'nan, Shandong, 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:

山东中医药大学附属医院 

Primary sponsor:

Affiliated Hospital of Shandong University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

山东省济南市历下区经十路16369号 

Primary sponsor's address:

16369 Jingshi Road, Lixia District, Ji'nan, Shandong, 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):

山东

市(区县):

济南

Country:

China

Province:

Shandong

City:

Ji'nan

单位(医院):

山东省科学技术厅

具体地址:

舜华路607号

Institution
hospital:

Department of Science and Technology of Shandong Province

Address:

607 Shunhua Road

经费或物资来源:

山东省中医院心脑血管疾病临床医学研究中心 

Source(s) of funding:

Shandong Province Traditional Chinese Medicine Hospital Cardiovascular and Cerebrovascular Disease Clinical Medical Research Center 

研究疾病:

原发性高血压 

Target disease:

Essential Hypertension 

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:

I期+II期 

Study phase:

1-2 

研究目的:

本研究采用随机对照的临床研究方法,旨在评价藤菔降压片联合缬沙坦/氨氯地平干预原发性高血压(2级)肝阳上亢证临床疗效和安全性,为临床治疗提供客观证据。 

Objectives of Study:

The present study is aimed to evaluate the clinical efficacy and safety of Tengfu Jiangya tablets combined with Valsartan/Amlodipine in essential hypertension (grade 2) with the hyperfunction of liver yang by random-controlled clinical research methods, which can provide objective evidence for clinical treatment. 

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.年龄在18-75岁之间; 2.同时符合2级高血压病西医诊断标准和肝阳上亢证中医证候辨证标准; 3.经高血压病的血压水平、心血管风险分层确定为2级原发性高血压、中危患者,血压符合以下3条中的任意1条: (1)收缩压160-179mmHg和(或)舒张压100-109 mmHg,既往未服用任何降压药物,未见心脑肾等并发症; (2)已明确诊断为原发性高血压,经改善生活方式或者其它形式的非药物治疗3个月血压仍未达标,维持在160-179/100-109mmHg者; (3)已明确诊断为原发性高血压,经改善生活方式或者其它形式的非药物治疗并口服降压药物治疗3个月血压仍未达标,维持在160-179/100-109mmHg者; 4.患者明确诊断为高血压病的病程必须大于3个月; 5.知情同意并签署知情同意书者。 

Inclusion criteria

1. Aged between 18-75 years old; 2. Patients who meet the western diagnostic standard of grade 2 hypertension and the TCM syndrome differentiation standard of hyperactivity of liver Yang syndrome; 3. The patients with grade 2 essential hypertension and moderate risk are identified according to the blood pressure level and cardiovascular risk stratification of hypertension, whose blood pressure meet any one of the following three criteria: (1) Systolic blood pressure 160-179mmHg and/or diastolic blood pressure 100-109 mmHg, no previous use of any antihypertensive drugs, no complications such as heart, brain and kidney; (2) Patients who have been clearly diagnosed as essential hypertension and whose blood pressure is still not up to the standard after 3 months of improved lifestyle or other forms of non-drug therapy, maintaining the blood pressure at 160-179/100-109mmhg; (3) Patients who have been clearly diagnosed as essential hypertension and whose blood pressure is still not up to the standard after 3 months of improved lifestyle or other forms of non-drug therapy and oral antihypertensive medication, maintaining the blood pressure at 160-179/100-109mmhg; 4. Patients whose course of hypertension must be more than 3 months; 5. Patients with informed consent and signing informed consent.  

排除标准:

1.各种继发性高血压病; 2.近3个月内曾接受其它新药临床实验者; 3.中重度糖尿病患者或半年内有心肌梗死或有脑卒中史者; 4.妊娠或准备妊娠者以及哺乳期妇女; 5.既往对多种药物过敏者或者过敏体质者; 6.合并有精神病、酗酒和或精神活性物质药物滥用者和依赖者; 7.同时合并以下器官损害或疾病者:心绞痛、心力衰竭、短暂性脑缺血发作、高血压性脑病、视网膜病变(伴或不伴有视乳头水肿)、血浆肌酐浓度2.0mg/dl 以上肾功衰竭、肝功能衰竭、主动脉夹层或主动脉瘤,动脉闭塞性疾病症状明显者; 8.目前已经服用缬沙坦80mg/氨氯地平5mg及其他ARB/CCB类复方药物,血压水平仍在2级及以上的患者。 

Exclusion criteria:

1. With various secondary hypertension; 2. Patients Received other new drugs in the past 3 months; 3. Patients with moderate or severe diabetes or patients with myocardial infarction or cerebral apoplexy within half a year; 4. Pregnant or pregnant women and women in lactation; 5. Patients who are allergic to a variety of drugs or allergic constitution; 6. Patients with mental illness, alcoholism and/or psychoactive substance abuse and dependence; 7. With combining with the following organ damage or disease, angina pectoris, heart failure, transient brain, hypertensive encephalopathy, retinopathy (with or without apparent papillary edema), plasma creatinine concentration of 2.0 mg/dl or more renal function failure, liver failure, or aortic aneurysm, aortic dissecting aneurysm artery occlusive disease symptoms. 8. At present, patients who have taken valsartan 80mg/amlodipine 5mg and other ARB/CCB compound drugs, and whose blood pressure is still level 2 and above. 

研究实施时间:

Study execute time:

From2020-07-01To 2022-06-01 

征募观察对象时间:

Recruiting time:

From2020-07-01To 2022-06-01 

干预措施:

Interventions:

组别:

试验组

样本量:

144

Group:

Experimental group

Sample size:

干预措施:

缬沙坦/氨氯地平+藤菔降压片

干预措施代码:

Intervention:

Valsartan+Amlodipine+Tengfu Jiangya tablets

Intervention code:

组别:

对照组

样本量:

144

Group:

control group

Sample size:

干预措施:

缬沙坦/氨氯地平+藤菔降压片安慰剂

干预措施代码:

Intervention:

Valsartan/Amlodipine+Tengxian antihypertensive tablets placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东 

市(区县):

 

Country:

China 

Province:

Shandong 

City:

 

单位(医院):

山东中医药大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Hospital of Shandong University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

 

Country:

China 

Province:

Shandong 

City:

 

单位(医院):

蓬莱市中医医院 

单位级别:

三级甲等 

Institution
hospital:

Penglai City Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

 

Country:

China 

Province:

Shandong 

City:

 

单位(医院):

沂南县中医医院 

单位级别:

二级甲等 

Institution
hospital:

Yinan County Hospital of Traditional Chinese Medicine  

Level of the institution:

Second Class A Hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

 

Country:

China 

Province:

Shandong 

City:

 

单位(医院):

淄博市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Zibo Central Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

 

Country:

China 

Province:

Shandong 

City:

 

单位(医院):

山东第一医科大学第三附属医院(山东省医学科学院附属医院) 

单位级别:

三级甲等 

Institution
hospital:

The Third Affiliated Hospital of Shandong First Medical University (Affiliated Hospital of Shandong Academy of Medical Sciences)  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

 

Country:

China 

Province:

Shandong 

City:

 

单位(医院):

青岛市中医医院 (青岛市海慈医疗集团) 

单位级别:

三级甲等 

Institution
hospital:

Qingdao Chinese Medicine Hospital (Qingdao Haici Medical Group)  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

 

Country:

China 

Province:

Shandong 

City:

 

单位(医院):

烟台中医医院 

单位级别:

三级甲等 

Institution
hospital:

Yantai Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

中医证候积分

指标类型:

主要指标 

Outcome:

Syndrome score of TCM

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

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:

血脂

指标类型:

主要指标 

Outcome:

Blood fat

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血糖

指标类型:

主要指标 

Outcome:

Blood sugar

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿微量白蛋白

指标类型:

主要指标 

Outcome:

Urinary microalbumin

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿酸

指标类型:

主要指标 

Outcome:

Uric acid

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

同型半胱氨酸

指标类型:

主要指标 

Outcome:

Homocysteine(HCY)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

超敏C反应蛋白

指标类型:

主要指标 

Outcome:

Hypersensitive c-reactive protein

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心电图

指标类型:

副作用指标 

Outcome:

Electrocardiograph (ECG)

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝功能

指标类型:

副作用指标 

Outcome:

liver function

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肾功能

指标类型:

副作用指标 

Outcome:

kedney function

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:

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:

标本中文名:

尿液

组织:

Sample Name:

Urine

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

粪便

组织:

Sample Name:

stool

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 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):

应用SAS 9.2统计软件生成生成随机序列号

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

Generate random sequence Numbers using SAS 9.2 statistical software

盲法:

双盲

Blinding:

Double blind

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

是Yes

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):

以论文形式公开发表

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

The results will be published in papers

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:

数据以病历记录表和Excel格式保存

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

Data will be stored as case record form and Excel files

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-03-08
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