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降脂通络软胶囊治疗原发性高脂血症(气滞血瘀证)有效性及安全性的随机、双盲双模拟、阳性药平行对照、多中心临床试验
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注册号:

Registration number:

ChiCTR1800014435 

最近更新日期:

Date of Last Refreshed on:

2018-01-13 

注册时间:

Date of Registration:

2018-01-13 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

降脂通络软胶囊治疗原发性高脂血症(气滞血瘀证)有效性及安全性的随机、双盲双模拟、阳性药平行对照、多中心临床试验 

Public title:

Jiangzhi Tongluo soft capsules for the treatment of primary hyperlipidemia (qi stagnation and blood stasis syndrome)Effectiveness and safety of randomized, double-blind, double-dummy, positive drug parallel control, multicenter clinical trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

降脂通络软胶囊治疗原发性高脂血症(气滞血瘀证)有效性及安全性的随机、双盲双模拟、阳性药平行对照、多中心临床试验 

Scientific title:

Jiangzhi Tongluo soft capsules for the treatment of primary hyperlipidemia (qi stagnation and blood stasis syndrome)Effectiveness and safety of randomized, double-blind, double-dummy, positive drug parallel control, multicenter clinical 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:

 

申请注册联系人:

李凡 

研究负责人:

马国庆 

Applicant:

Fan Li 

Study leader:

Guoqing Ma 

申请注册联系人电话:

Applicant telephone:

+86 15833218791 

研究负责人电话:

Study leader's telephone:

+86 15133196552 

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:

lv9610@163.com 

研究负责人电子邮件:

Study leader's E-mail:

670344215@qq.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:

黑龙江省哈尔滨市南岗区果戈里大街411号 

研究负责人通讯地址:

黑龙江省哈尔滨市南岗区果戈里大街411号 

Applicant address:

411 Guogeli Street, Nangang District, Harbin, Heilongjiang, China 

Study leader's address:

411 Guogeli Street, Nangang District, Harbin, Heilongjiang, China 

申请注册联系人邮政编码:

Applicant postcode:

051430 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

黑龙江中医药大学附属第二医院 

Applicant's institution:

Second Affiliated Hospital of Heilongjiang 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:

[2016]08 

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:

黑龙江中医药大学附属第二医院伦理委员会 

Name of the ethic committee:

Second Affiliated Hospital of Heilongjiang University of Chinese Medicine ethic committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-02-03 

伦理委员会联系人:

孙兴华 

Contact Name of the ethic committee:

Xinghua Sun 

伦理委员会联系地址:

黑龙江省哈尔滨市南岗区果戈里大街411号 

Contact Address of the ethic committee:

411 Guogeli Street, Nangang District, Harbin, Heilongjiang 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0451-87090230 

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:

黑龙江中医药大学附属第二医院 

Primary sponsor:

Second Affiliated Hospital of Heilongjiang University of Chinese Medicine 

研究实施负责(组长)单位地址:

黑龙江省哈尔滨市南岗区果戈里大街411号 

Primary sponsor's address:

411 Guogeli Street, Nangang District, Harbin, Heilongjiang, 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):

黑龙江

市(区县):

哈尔滨

Country:

China

Province:

Heilongjiang

City:

Harbin

单位(医院):

黑龙江中医药大学附属第二医院

具体地址:

黑龙江省哈尔滨市南岗区果戈里大街411号

Institution
hospital:

Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

Address:

411 Guogeli Street, Nangang District, Harbin, Heilongjiang

经费或物资来源:

自筹 

Source(s) of funding:

self-financing 

研究疾病:

原发性高脂血症 

Target disease:

Primary hyperlipidemia 

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:

Post-market 

研究目的:

评价降脂通络软胶囊治疗原发性高脂血症(气滞血瘀证)有效性及安全性的随机、双盲双模拟、阳性药平行对照、多中心临床试验 

Objectives of Study:

To evaluate the efficacy and safety of Jiangzhi Tongluo soft capsule in the treatment of primary hyperlipidemia (qi stagnation and blood stasis syndrome) randomized, double-blind double-dummy, positive drug parallel control, multicenter clinical trial. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

纳入标准:

(1)符合原发性高脂血症西医诊断标准者; (2)符合中医辨证气滞血瘀证者; (3)导入期和基线期测量空腹LDL-C≥4.14mmol/L,TC≥6.22mmol/L、TG≥2.26mmol/L,且两次差值不超过12%;三者满足其一即可; (4)调脂药物或其他降脂措施至少停用4周以上; (5)高脂血症患者膳食评价≤5分; (6)年龄18~70周岁(包括18周岁和70周岁),性别不限; (7)自愿受试并签署知情同意书者。 

Inclusion criteria

(1) Meet the criteria of Western diagnosis of primary hyperlipidemia; (2) In line with TCM qi stagnation and blood stasis syndrome; (3) The fasting LDL-C≥4.14mmol/L, TC≥6.22mmol/L, TG≥2.26mmol/L, and the difference between two times should not exceed 12% ; (4) Lipid-lowering drugs or other lipid-lowering measures to disable at least 4 weeks; (5) Dietary evaluation of patients with hyperlipidemia ≤ 5 points; (6) Aged 18 ~ 70 years male and female; (7) Those who volunteered and signed informed consent. 

排除标准:

(1)全身系统性疾病引起的继发性血脂异常如糖尿病甲状腺功能减退、库欣综合征、肝肾疾病、系统性红斑狼疮、骨髓瘤、过量饮酒等引起的血脂异常; (2)药物原因引起的继发性血脂异常:如噻嗪类利尿剂、β-受体阻滞剂、长期大量使用糖皮质激素及某些避孕药等; (3)正在使用肝素、甲状腺素治疗药和其它影响血脂代谢药物的患者,以及临床研究中必须长期服用抗凝治疗者; (4)家族性高胆固醇血症患者; (5)过去6个月内有急性冠脉综合征(如心肌梗死、不稳定型心绞痛等)或急性脑血管意外者(如中风史等),以及患有其他严重的心血管疾病者,或过去18个月内进行过PCI及CABG等重大手术者; (6)糖尿病血糖控制不稳定,糖化血红蛋白(HbA1c)>7%,或伴有糖尿病并发症(糖尿病性肾病、周围神经病变)需要药物控制的患者; (7)合并严重肝肾功能损害患者(ALT、AST>正常值上限的1.5倍,Cr>正常值上限); (8)药物控制不佳的高血压病患者(服药后血压水平:收缩压≥160mmHg,舒张压>90mmHg)或有低血压(静息坐位血压)<90/50mmHg; (9)精神病患者、酒精依赖者或有药物滥用史者; (10)妊娠及哺乳期妇女及服药期间或服药停止后3个月内准备生育者; (11)过敏体质或既往对多种药物过敏者,或对研究用药中的成分过敏者; (12)试验前3个月参加过其他临床研究者; (13)其他研究者认为不宜参与本研究的患者。 

Exclusion criteria:

(1) Secondary dyslipidemia due to systemic diseases such as diabetic hypothyroidism, Cushing's syndrome, liver and kidney disease, systemic lupus erythematosus, myeloma, excessive alcohol consumption caused dyslipidemia; (2) Drug-induced secondary dyslipidemia: such as thiazide diuretics, β-blockers, long-term heavy use of glucocorticoid and some contraceptives; (3) Heparin, thyroxine, and other drugs that affect blood lipid metabolism are being used, and anticoagulants are required for long-term clinical trials. (4) Familial hypercholesterolemia patients; (5) Those with acute coronary syndromes (such as myocardial infarction, unstable angina, etc.) or acute cerebrovascular accidents (such as stroke history) in the past 6 months and those with other serious cardiovascular diseases, or in the past 18 months had PCI and CABG and other major surgery; (6) Patients with unstable diabetic glycemic control, HbA1c> 7%, or diabetic complications (diabetic nephropathy, peripheral neuropathy) requiring medication control; (7) patients with severe liver and kidney dysfunction (ALT, AST> 1.5 times the upper limit of normal, Cr> upper limit of normal); (8) Hypertensive patients with poor drug control (blood pressure level after treatment: systolic blood pressure ≥160mmHg, diastolic blood pressure> 90mmHg) or hypotension (resting sitting blood pressure) <90 / 50mmHg; (9) Persons with mental illness, alcohol dependence or history of drug abuse; (10) Pregnant and lactating women and during their medication or within 3 months after the cessation of medication to prepare their children; (11) Allergy or previous allergy to many drugs, or allergic to the components of the study medication; (12) 3 months prior to the trial participated in other clinical studies; (13) Patients who other researchers think should not be involved in this study. 

研究实施时间:

Study execute time:

From2016-02-03To 2017-02-02 

干预措施:

Interventions:

组别:

试验组

样本量:

360

Group:

treatment group

Sample size:

干预措施:

降脂通络软胶囊

干预措施代码:

Intervention:

Jiangzhi Tongluo soft capsules

Intervention code:

组别:

对照组

样本量:

120

Group:

control group

Sample size:

干预措施:

蒲参胶囊

干预措施代码:

Intervention:

Pushen capsules

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

哈尔滨 

Country:

China 

Province:

Heilongjiang 

City:

Harbin 

单位(医院):

黑龙江中医药大学附属第二医院 

单位级别:

三级甲等 

Institution
hospital:

Second Affiliated Hospital of Heilongjiang University of Chinese Medicine  

Level of the institution:

Tertiary A hospital  

国家:

中国 

省(直辖市):

甘肃省 

市(区县):

兰州 

Country:

China 

Province:

Gansu 

City:

Lanzhou 

单位(医院):

甘肃省中医院 

单位级别:

三级甲等 

Institution
hospital:

Gansu Provincial Hospital of TCM  

Level of the institution:

Tertiary A hospital  

国家:

中国 

省(直辖市):

山东 

市(区县):

日照 

Country:

China 

Province:

Shandong 

City:

Rizhao 

单位(医院):

日照市中医医院 

单位级别:

三级甲等 

Institution
hospital:

Ri Zhao Hospital of TCM  

Level of the institution:

Tertiary A hospital  

国家:

中国 

省(直辖市):

河北 

市(区县):

曲阜 

Country:

China 

Province:

Hebei 

City:

Qufu 

单位(医院):

曲阜市中医院 

单位级别:

三级甲等 

Institution
hospital:

Qu Fu Hospital of TCM  

Level of the institution:

Tertiary A hospital  

国家:

中国 

省(直辖市):

河南 

市(区县):

漯河 

Country:

China 

Province:

Henan 

City:

Luohe 

单位(医院):

漯河市中医院 

单位级别:

三级甲等 

Institution
hospital:

Luohe Hospital of Chinese medicine  

Level of the institution:

Tertiary A hospital  

国家:

中国 

省(直辖市):

山东 

市(区县):

泰安 

Country:

China 

Province:

Shandong 

City:

Taian 

单位(医院):

中国人民解放军第八十八医院 

单位级别:

三级甲等 

Institution
hospital:

Eighty-eighth Hospital of Chinese People's Liberation Army  

Level of the institution:

Tertiary A hospital  

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):

唐山市中医医院 

单位级别:

三级甲等 

Institution
hospital:

Tangshan hospital of TCM  

Level of the institution:

Tertiary A hospital  

国家:

中国 

省(直辖市):

辽宁 

市(区县):

沈阳 

Country:

China 

Province:

Liaoning 

City:

Shenyang 

单位(医院):

辽宁中医药大学附属第四医院 

单位级别:

三级甲等 

Institution
hospital:

Liaoning University of Traditional Chinese Medicinal Hospital subsidiary Fourth  

Level of the institution:

Tertiary A hospital  

测量指标:

Outcomes:

指标中文名:

低密度脂蛋白

指标类型:

主要指标 

Outcome:

Low-density lipoprotein

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总胆固醇

指标类型:

次要指标 

Outcome:

Total Cholesterol

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

甘油三酯

指标类型:

次要指标 

Outcome:

Triglyceride

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

高密度脂蛋白

指标类型:

次要指标 

Outcome:

High-density lipoprotein

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医症候评分

指标类型:

次要指标 

Outcome:

TCM Syndrome Score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医单项症状

指标类型:

次要指标 

Outcome:

Chinese medicine symptoms

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心血管事件发生率

指标类型:

次要指标 

Outcome:

The incidence of cardiovascular events

Type:

Secondary 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:

结束

Completed

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

随机区组设计

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

randomized block design

盲法:

Blinding:

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

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):

通过resman提供原始数据查询

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

IPD will be public accessable via resman

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:

病例记录表及电子采集和管理系统

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

Case Record Form and Electronic Data Capture

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-01-13
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