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QSHY方颗粒剂治疗痰瘀互结型高脂血症的前瞻性临床试验
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注册号:

Registration number:

ChiCTR2000034125 

最近更新日期:

Date of Last Refreshed on:

2020-06-25 

注册时间:

Date of Registration:

2020-06-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

QSHY方颗粒剂治疗痰瘀互结型高脂血症的前瞻性临床试验 

Public title:

A prospective randomized controlled clinical trial for QSHY granule in the treatment of hyperlipidemia of phlegm and blood stasis type 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

QSHY方颗粒剂治疗痰瘀互结型高脂血症的前瞻性临床试验 

Scientific title:

A prospective randomized controlled clinical trial for QSHY granule in the treatment of hyperlipidemia of phlegm and blood stasis type 

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:

ChiMCTR2000003430 

申请注册联系人:

孙元隆 

研究负责人:

赵瑜 

Applicant:

Sun Yuanlong 

Study leader:

Zhao Yu 

申请注册联系人电话:

Applicant telephone:

+86 13917417142 

研究负责人电话:

Study leader's telephone:

+86 15021115660 

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:

823951231@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

cathy150@139.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:

上海市浦东新区张衡路528号3号楼 

研究负责人通讯地址:

上海市浦东新区张衡路528号3号楼 

Applicant address:

Building 3, 528 Zhangheng Road, Pudong New District, Shanghai, China 

Study leader's address:

Building 3, 528 Zhangheng Road, Pudong New District, Shanghai, 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:

上海中医药大学附属曙光医院 

Applicant's institution:

Shuguang Hospital Affiliated to Shanghai 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:

2019-780-135-01 

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:

上海中医药大学附属曙光医院伦理委员会 

Name of the ethic committee:

IRB of Shuguang Hospital affiliated with Shanghai University of TCM 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-12-10 

伦理委员会联系人:

马俊坚 

Contact Name of the ethic committee:

Ma Junjian 

伦理委员会联系地址:

上海市浦东新区张衡路528号 

Contact Address of the ethic committee:

528 Zhangheng Road, Pudong New District, Shanghai, 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:

上海中医药大学附属曙光医院 

Primary sponsor:

Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine 

研究实施负责(组长)单位地址:

上海市浦东新区张衡路528号 

Primary sponsor's address:

528 Zhangheng Road, Pudong New District, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属曙光医院

具体地址:

浦东新区张衡路528号

Institution
hospital:

Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine

Address:

528 Zhangheng Road, Pudong New District

经费或物资来源:

上海市科委 

Source(s) of funding:

Science and Technology Commission of Shanghai Municipality 

研究疾病:

高脂血症 

Target disease:

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:

探索性研究/预试验 

Study phase:

研究目的:

评价QSHY方颗粒剂治疗痰瘀互结型高脂血症的临床疗效及安全性。 

Objectives of Study:

To evaluate the clinical efficacy and safety of QSHY granule in the treatment of hyperlipidemia of Phlegm Blood Stasis Type 

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、符合高脂血症中西医诊断标准,西医诊断参照中国成人血脂异常防治指南修订联合委员会 2016 年中国成人血脂异常防治指南。中医诊断、辨证标准及其依据参照中华中医药学会心病分会的血脂异常中医诊疗标准; 2、年龄大于18岁; 3、无 ASCVD 者, 3.4mmol/L ( 130mg/dL )<空腹 LDL-C<4.9mmol/L( 190mg/dL);ASCVD 者,2.6mmol/L( 100mg/dL)<空腹 LDL-C< 4.9mmol/L( 190mg/dL); 4、空腹 TG< 5.7 mmol/L( 500mg/dL); 5、BMI <35 kg/m2; 6、愿意并能够遵守预定的就诊计划,饮食运动指导,实验室检查和其他研究程序; 7、签署患者知情同意书。 

Inclusion criteria

1. For patients who meet the diagnostic criteria of Chinese and Western medicine for hyperlipidemia, the guidelines for the prevention and treatment of Chinese adult dyslipidemia in 2016 were revised by referring to the guidelines for the prevention and treatment of Chinese adult dyslipidemia. TCM diagnosis, syndrome differentiation criteria and their basis refer to the TCM diagnosis and treatment criteria for dyslipidemia of the heart disease branch of the Chinese society of TCM. 2. Patients older than 18 years old; 3. In the absence of ASCVD, 3.4mmol/l (130mg / dl) was less than 4.9mmol/l (190mg / dl); in the absence of ASCVD, 2.6mmol/l (100mg / dl) was less than 4.9mmol/l (190mg / dl); 4. Patients with fasting TG < 5.7 mmol/L (500mg/dL); 5. BMI < 35 kg/m2; 6. Willing and able to follow the scheduled visit plan, diet and exercise instructions, laboratory tests and other procedures. 7. Patients who signed informed consent. 

排除标准:

1、筛选前 4 周使用其它降脂药而影响疗效评价者; 2、可能干扰血脂水平的不受控制的内分泌或代谢疾病者; 3、口服皮质类固醇药物者; 4、筛选前 1 年内有酒精或麻醉药物滥用史者; 5、ASCVD 高危或极高危者; 6、筛选前 6 个月, 充血性心力衰竭,不稳定型心绞痛,心肌梗死, 中风、 冠状动脉搭桥手术或血管成形术,或不稳定或严重外周动脉疾病的病史者; 7、近一年内实施过胃肠减肥手术者或者近 3 个月内服用减肥药物体重下降>10%者; 8、孕妇、哺乳期妇女及心血管、肺、肾、造血系统等原发性疾病及恶性肿瘤等其他重大疾病者。 

Exclusion criteria:

1. The patients who used other lipid-lowering drugs in the first 4 weeks were screened; 2. Patients with uncontrolled endocrine or metabolic diseases that may interfere with blood lipid levels; 3. Patients taking oral corticosteroids; 4. Screening of patients with a history of alcohol or narcotic drug abuse in the previous year; 5. Patients with high or very high risk of ASCVD; 6. Patients with congestive heart failure, unstable angina, myocardial infarction, stroke, coronary artery bypass surgery or angioplasty, or unstable or serious peripheral artery disease in the first 6 months were screened; 7. Patients who have undergone gastrointestinal surgery in the past year or who have taken weight-loss drugs in the past 3 months have lost more than 10% of their body weight; 8. Pregnant women, lactating women and patients with cardiovascular, lung, kidney, hematopoietic system and other major diseases such as malignant tumors. 

研究实施时间:

Study execute time:

From2020-01-01To 2022-12-31 

征募观察对象时间:

Recruiting time:

From2020-06-23To 2022-12-30 

干预措施:

Interventions:

组别:

试验组

样本量:

105

Group:

experimental group

Sample size:

干预措施:

QSHY方颗粒剂

干预措施代码:

Intervention:

QSHY granules

Intervention code:

组别:

对照组

样本量:

105

Group:

control group

Sample size:

干预措施:

QSHY 方模拟颗粒剂

干预措施代码:

Intervention:

QSHY simulated granules

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海中医药大学附属曙光医院 

单位级别:

三级甲等 

Institution
hospital:

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

血脂

指标类型:

主要指标 

Outcome:

serum lipid

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝肾功能

指标类型:

次要指标 

Outcome:

Hepatorenal function

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

次要指标 

Outcome:

routine blood test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿常规

指标类型:

次要指标 

Outcome:

routine urine test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

空腹血糖

指标类型:

次要指标 

Outcome:

Fasting blood glucose

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:

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:

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 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):

采用DAS临床试验中央随机系统申请随机号和配发药物,按照1:1的比例将患者随机分为治疗组与对照组。

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

The DAS central random system of clinical trials is used to apply for random number and dispensing drugs, the patients are randomly divided into treatment group and control group according to the ratio of 1:1.

盲法:

双盲

Blinding:

Double blind

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

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):

网络平台

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

Web-based public database(http://www.medresman.org.cn/login.aspx)

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:

收集crf表,并及时上传数据至EDC管理

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

Collect CRF and upload data to EDC management in time

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-06-25
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