蒲参胶囊治疗缺血性脑卒中真实世界研究

注册号:

Registration number:

ITMCTR2025000255

最近更新日期:

Date of Last Refreshed on:

2025-02-13

注册时间:

Date of Registration:

2025-02-13

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

蒲参胶囊治疗缺血性脑卒中真实世界研究

Public title:

Real world study on the treatment of ischemic stroke with Pushen capsules

注册题目简写:

蒲参胶囊真实世界研究

English Acronym:

Real world research on Pu Shen capsules

研究课题的正式科学名称:

蒲参胶囊治疗缺血性脑卒中真实世界研究

Scientific title:

Real world study on the treatment of ischemic stroke with Pushen capsules

研究课题的正式科学名称简写:

Scientific title acronym:

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:

王琴

研究负责人:

徐运

Applicant:

Wang Qin

Study leader:

Xu Yun

申请注册联系人电话:

Applicant telephone:

15161096967

研究负责人电话:

Study leader's telephone:

+86 13914764479

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:

wangqin@suzhongyy.com

研究负责人电子邮件:

Study leader's E-mail:

xuyun20042001@aliyun.com

申请单位网址(自愿提供):

Study leader's 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:

江苏省泰州市姜堰区苏中路1号

研究负责人通讯地址:

江苏省南京市中山路321号

Applicant address:

1 Suzhong Road Jiangyan District Taizhou Jiangsu

Study leader's address:

321 Zhongshan Road Nanjing Jiangsu

申请注册联系人邮政编码:

Applicant postcode:

225500

研究负责人邮政编码:

Study leader's postcode:

210008

申请人所在单位:

苏中药业集团股份有限公司

Applicant's institution:

Suzhong Pharmaceutical Group Co. Ltd.

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2024-445-02

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

南京大学医学院附属鼓楼医院医学伦理委员会

Name of the ethic committee:

Ethics Committee of Gulou Hospital Affiliated to Nanjing University School of Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/9/5 0:00:00

伦理委员会联系人:

戴红阳

Contact Name of the ethic committee:

Dai Hongyang

伦理委员会联系地址:

江苏省南京市中山路321号

Contact Address of the ethic committee:

321 Zhongshan Road Nanjing Jiangsu

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 25 68182923

伦理委员会联系人邮箱:

Contact email of the ethic committee:

gyethics@163.com

研究实施负责(组长)单位:

南京大学医学院附属鼓楼医院

Primary sponsor:

Drum Tower Hospital Affiliated to Nanjing University School of Medicine

研究实施负责(组长)单位地址:

江苏省南京市鼓楼区中山路321

Primary sponsor's address:

321 Zhongshan Road Nanjing Jiangsu

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):

泰州

Country:

China

Province:

Jiangsu

City:

Taizhou

单位(医院):

苏中药业集团股份有限公司

具体地址:

姜堰区苏中路1号

Institution
hospital:

Suzhong Pharmaceutical Group Co.Jiangsu Province

Address:

1 Suzhong Road Jiangyan District

经费或物资来源:

苏中药业集团股份有限公司

Source(s) of funding:

Suzhong Pharmaceutical Group Co. Ltd.

研究疾病:

缺血性脑卒中

研究疾病代码:

Target disease:

Ischemic stroke

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

单臂

Single arm

研究所处阶段:

Study phase:

上市后药物

Post-marketing clinical trial

研究目的:

使用真实世界证据作为外部对照,评价蒲参胶囊在临床实践中治疗缺血性脑卒中的有效性和安全性。

Objectives of Study:

Using real-world evidence as an external control evaluate the effectiveness and safety of Pushen capsules in the treatment of ischemic stroke in clinical practice.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

(1)入院诊断为缺血性脑卒中的患者(符合《中国急性缺血性脑卒中诊治指南2018》缺血性脑卒中诊断标准),符合卒中病因分型(TOAST)为大动脉粥样硬化(Large-artery atherosclerosis, LAA); (2)发病7天以内的患者; (3)患者对研究知情同意并签署知情同意书。

Inclusion criteria

(1) Patients admitted to the hospital who were diagnosed as ischemic stroke (in line with the diagnostic criteria for ischemic stroke in the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018) and those who met the TOAST were diagnosed as Large artery atherosclerosis (LAA); (2) Patients who have been ill for less than 7 days; (3) Patients give informed consent to the study and sign an informed consent form.

排除标准:

(1)既往半年内有脑出血病史或出血性脑血管病(经头部CT/MRI确诊,包括蛛网膜下腔出血、脑出血、其他颅内出血); (2)经检查证实由脑肿瘤、脑外伤、脑寄生虫病、代谢障碍、风湿性心脏病、冠心病及其它心脏病合并房颤附壁血栓脱落而引起脑栓塞者和不明原因型的患者; (3)糖尿病并发症者(如严重的糖尿病肾病导致肾功能不全者、糖尿病周围神经病变影响患者运动功能评价者、糖尿病酮症酸中毒者等)以及低血糖反复发作患者; (4)重度营养不良及严重的血液病患者(如低蛋白血症、重度贫血等)及严重的电解质紊乱经治疗不能纠正者; (5)合并有严重心、肺系统疾病以及慢性肝、肾功能障碍者,其中肝功损害ALT、AST>正常上限1.5倍者,肾功损害肌酐(Cr)>正常上限1.5倍者; (6)妊娠或哺乳期妇女及准备妊娠者; (7)法律规定的残疾患者(盲、聋、哑、智力障碍、精神障碍、肢体残疾); (8)已知对本药物成分过敏及过敏体质者; (9)研究者认为不适合参加本次临床研究者。

Exclusion criteria:

(1) History of cerebral hemorrhage or hemorrhagic cerebrovascular disease (diagnosed by head CT/MRI including subarachnoid hemorrhage cerebral hemorrhage and other intracranial hemorrhage) within the past six months; (2) Confirmed through examination that cerebral embolism is caused by brain tumors traumatic brain injury cerebral parasitic diseases metabolic disorders rheumatic heart disease coronary heart disease and other heart diseases combined with atrial fibrillation and thrombus detachment as well as patients of unknown etiology; (3) Diabetes complications (such as severe diabetes nephropathy leading to renal insufficiency diabetes peripheral neuropathy affecting patients' motor function evaluation diabetes ketoacidosis etc.) and recurrent hypoglycemia; (4) Patients with severe malnutrition and severe blood diseases (such as hypoalbuminemia severe anemia etc.) and severe electrolyte imbalances that cannot be corrected through treatment; (5) Patients with severe cardiovascular and pulmonary diseases as w

研究实施时间:

Study execute time:

From 2024-09-01

To      2026-12-31

征募观察对象时间:

Recruiting time:

From 2024-10-01

To      2025-12-31

干预措施:

Interventions:

组别:

疾病登记组

样本量:

703

Group:

Disease Registry Group

Sample size:

干预措施:

干预措施代码:

Intervention:

not have

Intervention code:

组别:

蒲参胶囊

样本量:

467

Group:

Pushen Capsules Group

Sample size:

干预措施:

蒲参胶囊(口服,一次4粒,一日3次),治疗12周;同时使用基础治疗用药。

干预措施代码:

Intervention:

4 capsules/time 3 times/day

Intervention code:

样本总量 Total sample size : 1170

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):

常州

Country:

China

Province:

Jiangsu

City:

Changzhou

单位(医院):

常州市第二人民医院

单位级别:

三甲

Institution/hospital:

Changzhou Second People's Hospital

Level of the institution:

Grade III Grade A

国家:

中国

省(直辖市):

江苏

市(区县):

苏州

Country:

China

Province:

Jiangsu

City:

Suzhou

单位(医院):

苏州大学附属第二医院

单位级别:

三甲

Institution/hospital:

Suzhou University Affiliated Second Hospital

Level of the institution:

Grade III Grade A

国家:

中国

省(直辖市):

山东

市(区县):

济宁

Country:

CHINA

Province:

Shandong

City:

Jining

单位(医院):

济宁市第一人民医院

单位级别:

三甲

Institution/hospital:

Jining First People's Hospital

Level of the institution:

Grade III Grade A

国家:

中国

省(直辖市):

江苏

市(区县):

泰州

Country:

China

Province:

Jiangsu

City:

Taizhou

单位(医院):

泰州市第二人民医院

单位级别:

三级乙等

Institution/hospital:

9/10000 9/10000 Real time translation of Taizhou Second People's Hospital Taizhou Second People's Hospital

Level of the institution:

Grade III Grade B

国家:

中国

省(直辖市):

山东

市(区县):

滕州

Country:

China

Province:

Shandong

City:

Tengzhou

单位(医院):

山东滕州中心人民医院

单位级别:

三甲

Institution/hospital:

Shandong Tengzhou Central People's Hospital

Level of the institution:

Grade III Grade A

国家:

中国

省(直辖市):

江苏

市(区县):

苏州

Country:

China

Province:

Jiangsu

City:

Suzhou

单位(医院):

苏州科技城医院

单位级别:

三级

Institution/hospital:

Suzhou Science and Technology City Hospital

Level of the institution:

Grade III

国家:

中国

省(直辖市):

江苏

市(区县):

连云港

Country:

China

Province:

Jiangsu

City:

Lianyungang

单位(医院):

连云港市第一人民医院

单位级别:

三甲

Institution/hospital:

Lianyungang First People's Hospital

Level of the institution:

Grade III Grade A

国家:

中国

省(直辖市):

江苏

市(区县):

淮安

Country:

China

Province:

Jiangsu

City:

Huaian

单位(医院):

淮安市第一人民医院

单位级别:

三甲

Institution/hospital:

Huaian First People's Hospital

Level of the institution:

Grade III Grade A

国家:

中国

省(直辖市):

江苏

市(区县):

泰州

Country:

China

Province:

Jiangsu

City:

Taizhou

单位(医院):

泰州中医院

单位级别:

三级甲等

Institution/hospital:

Taizhou Traditional Chinese Medicine Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

江苏

市(区县):

南通

Country:

China

Province:

Jiangsu

City:

Nantong

单位(医院):

南通市第一人民医院

单位级别:

三甲

Institution/hospital:

Nantong First People's Hospital

Level of the institution:

Grade III Grade A

国家:

中国

省(直辖市):

江苏

市(区县):

南京

Country:

China

Province:

Jiangsu

City:

Nanjing

单位(医院):

南京大学医学院附属鼓楼医院

单位级别:

三级甲等

Institution/hospital:

Drum Tower Hospital Affiliated to Nanjing University School of Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

河南

市(区县):

开封

Country:

China

Province:

Henan

City:

Kaifeng

单位(医院):

开封市人民医院

单位级别:

三级

Institution/hospital:

Kaifeng People's Hospital

Level of the institution:

Grade III

测量指标:

Outcomes:

指标中文名:

mRS评分改善率

指标类型:

次要指标

Outcome:

mRS score improvement rate

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医症状积分的变化值和变化率

指标类型:

次要指标

Outcome:

The change value and rate of TCM symptom 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:

蒙特利尔认知评估量表(MoCA量表)评分的变化值和变化率

指标类型:

次要指标

Outcome:

The change value and rate of change in the Montreal Cognitive Assessment Scale (MoCA) 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:

血脂四项变化情况

指标类型:

次要指标

Outcome:

Changes in Four Blood Lipids

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

简易智力状态检查量表(MMSE量表)评分的变化值和变化率

指标类型:

次要指标

Outcome:

The change value and rate of the Mini Mental State Examination (MMSE) 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:

心脑血管事件是否发生(脑卒中、心肌梗死、TIA、死亡等)

指标类型:

次要指标

Outcome:

Whether cardiovascular and cerebrovascular events occur (stroke myocardial infarction TIA death etc.)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗12周mRS评分为0~2分的受试者比例

指标类型:

主要指标

Outcome:

The proportion of subjects with mRS scores ranging from 0 to 2 after 12 weeks of treatment.

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

NIHSS评分的变化值和变化率

指标类型:

次要指标

Outcome:

The change value and rate of NIHSS 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:

mRS评分是否下降至0 ~1分

指标类型:

次要指标

Outcome:

Has the mRS score decreased to 0-1 points

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:

正在进行

Recruiting

年龄范围:

最小 18
Min age years
最大 80
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

不适用

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

NA

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

No

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):

不适用

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

NA

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:

EDC

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

EDC

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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