Register Now
Log In
中文/English
About ITMCTR|Search Trials|About Us|News
Efficacy of Xinshu Bao Tablets in Treating Stable Angina Pectoris in Patients with Qi Deficiency and Blood Stasis: A Multicenter Randomized Double-Blind Placebo-Controlled Trial

注册号：

Registration number：

ITMCTR2025001185

最近更新日期：

Date of Last Refreshed on：

2025-06-16

注册时间：

Date of Registration：

2025-06-16

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

评价心舒宝片治疗冠心病稳定型心绞痛气虚血瘀证患者的 随机、双盲、安慰剂平行对照、多中心临床试验

Public title：

Efficacy of Xinshu Bao Tablets in Treating Stable Angina Pectoris in Patients with Qi Deficiency and Blood Stasis: A Multicenter Randomized Double-Blind Placebo-Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评价心舒宝片治疗冠心病稳定型心绞痛气虚血瘀证患者的 随机、双盲、安慰剂平行对照、多中心临床试验

Scientific title：

Efficacy of Xinshu Bao Tablets in Treating Stable Angina Pectoris in Patients with Qi Deficiency and Blood Stasis: A Multicenter Randomized Double-Blind Placebo-Controlled Trial

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：

张杭斌

研究负责人：

黄抒伟

Applicant：

Zhang Hangbin

Study leader：

Huang Shuwei

申请注册联系人电话：

Applicant telephone：

19857166585

研究负责人电话：

Study leader's telephone：

13957121104

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：

zjzyyleon@163.com

研究负责人电子邮件：

Study leader's E-mail：

hsw1104@126.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：

浙江省杭州市滨江区滨文路548号

研究负责人通讯地址：

浙江省杭州市上城区邮电路54号

Applicant address：

No. 548 Binwen Road Binjiang District Hangzhou City Zhejiang Province

Study leader's address：

No. 54 Youdian Road Shangcheng District Hangzhou 310003 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：

浙江中医药大学中医心脑血管病研究院

Applicant's institution：

Institute of Traditional Chinese Medicine for Cardiovascular and Cerebrovascular Diseases Zhejiang Chinese Medical University

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：

2025-KLS-370-01

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

浙江中医药大学附属第一医院伦理委员会

Name of the ethic committee：

Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2025/5/20 0:00:00

伦理委员会联系人：

夏冰

Contact Name of the ethic committee：

Xia bing

伦理委员会联系地址：

杭州市上城区邮电路54号

Contact Address of the ethic committee：

No. 54 Post and Telecommunications Road Shangcheng District Hangzhou City

伦理委员会联系人电话：

Contact phone of the ethic committee：

13600519473

伦理委员会联系人邮箱：

Contact email of the ethic committee：

allan.xia.1989@163.com

研究实施负责（组长）单位：

浙江中医药大学附属第一医院

Primary sponsor：

First Affiliated Hospital of Zhejiang Chinese Medical University

研究实施负责（组长）单位地址：

杭州市上城区邮电路54号

Primary sponsor's address：

No. 54 Post and Telecommunications Road Shangcheng District Hangzhou City

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

浙江省

市(区县)：

杭州市

Country：

China

Province：

Zhejiang

City：

Hangzhou

单位(医院)：

浙江中医药大学中医心脑血管病研究院

具体地址：

浙江省杭州市滨江区滨文路548号

Institution
hospital：

Institute of Traditional Chinese Medicine for Cardiovascular and Cerebrovascular Diseases Zhejiang Chinese Medical University

Address：

No. 548 Binwen Road Binjiang District Hangzhou City Zhejiang Province

经费或物资来源：

浙江中医药大学中医心脑血管病研究院

Source(s) of funding：

Institute of Traditional Chinese Medicine for Cardiovascular and Cerebrovascular Diseases Zhejiang Chinese Medical University

研究疾病：

冠心病

研究疾病代码：

I25.101

Target disease：

Coronary heart disease

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

上市后药物

Post-marketing clinical trial

研究目的：

基于心舒宝片组方、功效特点，在治疗冠心病稳定性心绞痛（气虚血瘀证）有效的基础上，进一步挖掘心舒宝片疗效特点及干预复合心脑血管事件发生率；治疗后及远期效应。获得心舒宝片疗效的直接临床证据。 评价心舒宝片治疗冠心病稳定性心绞痛（气虚血瘀证）的安全性。

Objectives of Study：

Based on the formula and efficacy characteristics of Xinshubao Tablets on the basis of its effectiveness in treating stable angina pectoris of coronary heart disease (qi deficiency and blood stasis syndrome) further explore the therapeutic features of Xinshubao Tablets and the incidence of complex cardiovascular and cerebrovascular events in intervention. Post-treatment and long-term effects. Obtain direct clinical evidence of the therapeutic effect of Xinshubao Tablets. To evaluate the safety of Xinshubao Tablets in the treatment of stable angina pectoris (qi deficiency and blood stasis syndrome) caused by coronary heart disease.

药物成份或治疗方案详述：

心舒宝片是片仔癀公司生产的中药产品，心舒宝片由丹参、白芍、刺五加、郁金、山楂组成的中成药，具有活血化瘀、益气止痛之功效。临床上，该药可用于治疗冠心病气虚血瘀引起的胸闷、心绞痛、高血压病、高血脂、动脉粥样硬化等疾病。

Description for medicine or protocol of treatment in detail：

Xinshubao Tablets are traditional Chinese medicine products produced by Pianzhaihuang Company. Xinshubao Tablets are a Chinese patent medicine composed of Salvia miltiorrhiza Paeonia lactiflora Acanthopanax senticosus Curcuma curcuma and Hawthorn. They have the functions of promoting blood circulation removing blood stasis tonifying qi and relieving pain. Clinically this medicine can be used to treat chest tightness angina pectoris hypertension hyperlipidemia atherosclerosis and other diseases caused by qi deficiency and blood stasis in coronary heart disease.

纳入标准：

符合下列所有条件的患者可进入本试验： （1）受试者须能够理解本研究的程序和方法，能够与研究者进行良好的沟通，愿意严格遵守临床试验方案完成本试验，并自愿签署书面的知情同意书； （2）年龄18-80周岁（包括边界值），男女不限； （3）参照2018年《稳定性冠心病诊断与治疗指南》（中华医学会心血管病学分会动脉粥样硬化与冠心病学组），符合冠心病稳定性心绞痛疾病诊断； （4）加拿大心血管协会（CCS）心绞痛分级I~Ⅲ级； （5）筛选期和导入期，平均每周心绞痛发作次数2~7次（包括边界值）； （6）符合中医气虚血瘀证。

Inclusion criteria

Patients who meet all of the following conditions can enter this trial: (1) The subjects must be able to understand the procedures and methods of this study be able to communicate well with the researchers be willing to strictly follow the clinical trial protocol to complete this trial and voluntarily sign the written informed consent form; (2) Age: 18 to 80 years old (including the boundary value) gender not limited; (3) Referring to the "Guidelines for the Diagnosis and Treatment of Stable Coronary Heart Disease" in 2018 (Atherosclerosis and Coronary Heart Disease Group Cardiovascular Branch of the Chinese Medical Association) it is in line with the diagnosis of stable angina pectoris of coronary heart disease; (4) Canadian Cardiovascular Society (CCS) Angina pectoris classification grades I to III; (5) During the screening period and the introduction period the average number of angina pectoris attacks per week was 2 to 7 times (including the boundary value); (6) It conforms to the syndrome of qi deficiency and blood stasis in traditional Chinese medicine.

排除标准：

（1）合并引起的胸痛的其他疾病，如心脏神经症、胸膜炎、肋间神经痛、心包炎等； （2）筛选前4周内或试验期间计划服用长效硝酸酯类、曲美他嗪、尼可地尔、伊伐布雷等缓解冠心病心绞痛症状的药物（筛选前3个月内稳定使用β受体阻滞剂和钙通道阻滞剂除外）； （3）筛选前3个月内发生过急性心肌梗死或有梗死前症状；或筛选前3个月内有血管重建史或试验期间计划行血管重建术，如CABG或PCI； （4）合并严重心脏病、恶性高血压、严重心衰、严重心律失常等心血管疾病；或合并其他严重的或无法控制的重要脏器或不稳定的系统性疾病，如脑血管意外、无法控制的糖尿病、无法控制的活动性感染、严重胃肠道疾病等； （5）筛选期肝肾功能异常：天冬氨酸转氨酶（AST）和/或丙氨酸转氨酶（ALT）≥2×ULN、总胆红素（TBIL）≥2×ULN、血肌酐（Cr）≥2×ULN； （6）对研究药物的组分过敏、过敏体质或既往对多种药物过敏； （7）合并中、重度且需要两种及两种以上药物治疗的抑郁、焦虑等精神性疾病； （8）过去一年内酒精依赖者或有药物滥用史； （9）妊娠期、哺乳期女性及服药期间或服药停止后3个月内准备生育； （10）试验前4周内参加过其他干预性临床研究者； 研究者认为不宜参与本研究的其他情况。

Exclusion criteria：

(1) Other diseases that cause chest pain in combination such as cardiac neurosis pleurisy intercostal neuralgia pericarditis etc. (2) It is planned to take long-acting nitrates trimetazine nicorandil ivabry and other drugs to relieve angina pectoris symptoms of coronary heart disease within 4 weeks before screening or during the trial period (except for the stable use of beta-blockers and calcium channel blockers within 3 months before screening). (3) Acute myocardial infarction or pre-infarction symptoms occurred within 3 months prior to screening; Or there is a history of vascular reconstruction within 3 months before screening or vascular reconstruction is planned during the trial such as CABG or PCI; (4) Combined with severe heart disease malignant hypertension severe heart failure severe arrhythmia and other cardiovascular diseases; Or it may be combined with other serious or uncontrollable important organ or unstable systemic diseases such as cerebrovascular accidents uncontrollable diabetes uncontrollable active infections severe gastrointestinal diseases etc. (5) Abnormal liver and kidney functions during the screening period: Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥2×ULN total bilirubin (TBIL) ≥2×ULN serum creatinine (Cr) ≥2×ULN; (6) Allergy to the components of the drug under study allergic constitution or previous allergy to multiple drugs; (7) Combined with moderate to severe mental disorders such as depression and anxiety that require treatment with two or more drugs; (8) Alcohol-dependent individuals or those with a history of drug abuse within the past year; (9) Pregnant and lactating women and those who are planning to have a baby during the medication period or within three months after stopping the medication; (10) Participated in other interventional clinical researchers within 4 weeks prior to the trial; Other circumstances where the researcher deems it inappropriate to participate in this study.

研究实施时间：

Study execute time：

从From 2025-05-21

至To      2028-07-31

征募观察对象时间：

Recruiting time：

从From 2025-06-30

至To      2027-07-31

干预措施：

Interventions：

组别：

试验组

样本量：

305

Group：

Experimental group

Sample size：

干预措施：

西医常规标准治疗+心舒宝片（po，2粒/bid）

干预措施代码：

Intervention：

Western medicine conventional standard treatment + Xinshubao Tablets (po 2 tablets per bid)

Intervention code：

组别：

对照组

样本量：

305

Group：

Control group

Sample size：

干预措施：

西医常规标准治疗+心舒宝片模拟剂（po，2粒/bid）

干预措施代码：

Intervention：

Western medicine conventional standard treatment + Xinshubao Tablet Mimic (po 2 tablets per bid)

Intervention code：

样本总量 Total sample size ： 610

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

浙江

市(区县)：

杭州

Country：

China

Province：

Zhejiang

City：

Hangzhou

单位(医院)：

浙江省新华医院

单位级别：

三甲

Institution/hospital：

Zhejiang Xinhua Hospital

Level of the institution：

Grade A Three

国家：

中国

省(直辖市)：

浙江省

市(区县)：

杭州市

Country：

China

Province：

Zhejiang

City：

Hangzhou

单位(医院)：

浙江中医药大学附属第一医院

单位级别：

三甲

Institution/hospital：

The First Affiliated Hospital of Zhejiang Chinese Medical University

Level of the institution：

Grade A Three

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医院

单位级别：

三甲

Institution/hospital：

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Level of the institution：

Grade A Three

国家：

中国

省(直辖市)：

浙江

市(区县)：

杭州

Country：

China

Province：

Zhejiang

City：

Hangzhou

单位(医院)：

浙江省立同德医院

单位级别：

三甲

Institution/hospital：

Zhejiang Provincial Tongde Hospital

Level of the institution：

Grade A Three

国家：

中国

省(直辖市)：

浙江

市(区县)：

金华

Country：

China

Province：

Zhejiang

City：

Jinhua

单位(医院)：

浙江大学医学院附属第四医院

单位级别：

三甲

Institution/hospital：

The Fourth Affiliated Hospital School of Medicine Zhejiang University

Level of the institution：

Grade A Three

国家：

中国

省(直辖市)：

河南

市(区县)：

郑州

Country：

China

Province：

Henan

City：

Zhengzhou

单位(医院)：

河南中医药大学第一附院

单位级别：

三甲

Institution/hospital：

The First Affiliated Hospital of Henan University of Chinese Medicine

Level of the institution：

Grade A Three

国家：

中国

省(直辖市)：

北京

市(区县)：

东城区

Country：

China

Province：

Beijing

City：

Dongcheng

单位(医院)：

首都医科大学附属北京中医医院

单位级别：

三甲

Institution/hospital：

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

Level of the institution：

Grade A Three

国家：

中国

省(直辖市)：

吉林

市(区县)：

长春

Country：

China

Province：

Jilin

City：

Changchun

单位(医院)：

长春中医院大学附属医院

单位级别：

三甲

Institution/hospital：

Changchun University Affiliated Hospital of Traditional Chinese Medicine

Level of the institution：

Grade A Three

国家：

中国

省(直辖市)：

陕西

市(区县)：

咸阳

Country：

China

Province：

Shanxi

City：

Xianyang

单位(医院)：

陕西中医药大学附属医院

单位级别：

三甲

Institution/hospital：

Affiliated Hospital of Shaanxi University of Chinese Medicine

Level of the institution：

Grade A Three

国家：

中国

省(直辖市)：

浙江

市(区县)：

杭州

Country：

China

Province：

Zhejiang

City：

Hangzhou

单位(医院)：

西湖大学附属杭州市第一医院

单位级别：

三甲

Institution/hospital：

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Level of the institution：

Grade A Three

国家：

中国

省(直辖市)：

天津

市(区县)：

河北区

Country：

China

Province：

Tianjin

City：

Hebei

单位(医院)：

天津中医药大学第二附院

单位级别：

三甲

Institution/hospital：

The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Level of the institution：

Grade A Three

国家：

中国

省(直辖市)：

北京

市(区县)：

西城区

Country：

China

Province：

Beijing

City：

Xicheng

单位(医院)：

中国中医科学院广安门医院

单位级别：

三甲

Institution/hospital：

Guang 'anmen Hospital

Level of the institution：

Grade A Three

测量指标：

Outcomes：

指标中文名：

心肌纤维化生物标志物：Ⅲ型胶原氨基端肽（PⅢNP）、层粘连蛋白（LN）、透明质酸（HA）

指标类型：

次要指标

Outcome：

Biomarkers of myocardial fibrosis: Type III collagen amino-terminal peptide (PⅢNP) laminin (LN) hyaluronic acid (HA)

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1年内，复合心脑血管终点事件发生率（非致死性卒中、非致命性心肌梗死、短暂性脑缺血发作、血管疾病死亡等）

指标类型：

次要指标

Outcome：

The incidence of composite cardiovascular and cerebrovascular endpoint events within one year of treatment (non-fatal stroke non-fatal myocardial infarction transient ischemic attack death from vascular diseases 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：

治疗后1年内，可获知的临床脑出血事件发生率；

指标类型：

次要指标

Outcome：

The incidence of clinical cerebral hemorrhage events that can be known within one year after treatment;

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

西雅图心绞痛量表评分

指标类型：

次要指标

Outcome：

Seattle Angina Scale 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：

心绞痛频率

指标类型：

主要指标

Outcome：

Angina pectoris frequency

Type：

Primary indicator

测量时间点：

比较治疗后8-12周与基线（随机给药前4周）相比

测量方法：

根据心绞痛日记，心绞痛发作频率的改善次数。

Measure time point of outcome：

Compare the 8-12 weeks after treatment with the baseline (4 weeks before random administration)

Measure method：

According to the angina pectoris diary, the number of times the frequency of angina pectoris attacks improves.

指标中文名：

血糖：空腹血糖（FPG），糖化血红蛋白（HbA1c）

指标类型：

次要指标

Outcome：

Blood glucose: Fasting blood glucose (FPG) glycated hemoglobin (HbA1c)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

中医证候气虚血瘀证候积分

指标类型：

次要指标

Outcome：

The syndrome score of qi deficiency and blood stasis in Traditional Chinese medicine

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

稳定型心绞痛CCS分级

指标类型：

次要指标

Outcome：

CCS classification of stable angina pectoris

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

6min步行试验

指标类型：

次要指标

Outcome：

6-minute walking 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：

血脂：总胆固醇（TC）、甘油三酯（TG）、高密度脂蛋白胆固醇（HDL-C）、低密度脂蛋白胆固醇（LDL-C）

指标类型：

次要指标

Outcome：

Blood lipids: Total cholesterol (TC) triglycerides (TG) high-density lipoprotein cholesterol (HDL-C) low-density lipoprotein cholesterol (LDL-C)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

心绞痛频率

指标类型：

次要指标

Outcome：

Angina pectoris frequency

Type：

Secondary indicator

测量时间点：

0-4周，和4-8周与基线（随机给药前4周）相比

测量方法：

Measure time point of outcome：

0-4 weeks and 4-8 weeks compared with the baseline (4 weeks before random administration)

Measure method：

指标中文名：

心绞痛应急用药使用量

指标类型：

次要指标

Outcome：

The dosage of emergency medication for angina pectoris

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：

无

Sample Name：

Blood

Tissue：

nothing

人体标本去向

使用后销毁

说明

实验室检查及组学分析

Fate of sample 

Destruction after use

Note：

Laboratory examination and omics analysis

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

尿常规检查

Fate of sample 

Destruction after use

Note：

Urine routine examination

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 80 岁
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）：

统计专家根据“临床研究随机化方案”对试验用药进行随机编码。受试者必须自始至终处于盲态。 （1）试验采用区组随机方法生成受试者和药品随机分配表，对完成导入期符合研究标准的受试者进行随机化入组。随机分配编码由统计分析单位非盲统计师采用SAS软件的PROC PLAN过程在计算机上产生随机分配表。试验用的各类药物将按随机分配表进行编码。 （2）患者签署知情同意书后，临床试验参加单位根据其进入研究的先后顺序给其分配唯一的筛选编号（该编号不得重复使用），进行筛选相关检查和评价。试验过程中，筛选成功的受试者分配受试者随机号和药品编号。

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

Statistical experts randomly code the investigational drugs according to the "Clinical research randomization protocol". The subjects must remain blind from beginning to end. (1) The trial adopted the block randomization method to generate the random allocation table of subjects and drugs and randomly enrolled the subjects who completed the introduction period and met the research criteria. Random allocation encoding is generated by non-blind statisticians from the statistical analysis unit using the PROC PLAN process of SAS software to create random allocation tables on the computer. All kinds of drugs used in the experiment will be coded according to the random allocation table. (2) After the patient signs the informed consent form the participating units of the clinical trial will assign a unique screening number to them based on the order in which they enter the study (this number cannot be reused) and conduct relevant screening examinations and evaluations. During the experiment the subjects who were successfully screened were assigned random subject numbers and drug numbers.

盲法：

采用双盲设计。心舒宝片由漳州片仔癀药业股份有限公司制备。心舒宝片模拟剂的主要成分为微晶纤维素、色素及糊精等，外观、大小、颜色、剂型、重量、味道和气味都与试验药物相同，由漳州片仔癀药业股份有限公司生产。 （1）设盲方法：对研究者及受试者设盲，设盲工作由临床研究负责单位负责人与申办方及统计人员共同完成，采用两级设盲法。一级设盲：即试验药物的设盲。对试验药和安慰剂进行统一包装，同时保证从外观上两组药物无差异。二级设盲：即试验药物包装盒的编号设盲。 （2）盲底保存：由与本次研究的临床观察、监查、统计分析等无关的人员，根据已形成的随机序列对试验组与对照组药物进行编码，将相应的药物编号贴在药物外部包装的醒目位置。设盲过程应有文字记录并由设盲所有人员签字，盲底在药物编盲后必须当场密封，由临床研究负责单位的机构专职人员与申办方分两处保存；应急信件随试验药物发往各中心保存，由机构负责人妥善保存，直至试验结束，任何人不得私自保存盲底信件与应急信件，如随意拆阅盲底信件，可视为此次临床试验的失败，如无故拆阅应急信件，以脱落病例处理。 （3）应急信件：每一编号的试验药物均有相对应的应急信件，应急信件必须标明真实的药物名称及药物的试验编码。信封外标明信件保存方法、拆封标准、药物编码（药物标签、应急信封封面及应急信封内的药物编码均应保持一致）。 （4）破盲规定：当患者发生严重的不良反应/事件需要判定组别进行治疗；当患者发生严重的并发症；症状恶化、必须采取紧急措施者；由于疗效的原因而退出的病例，不得破盲。 （5）破盲规程：揭盲前应尽可能先通知主要研究者和申办者的相关人员，再行紧急揭盲获取受试者的具体分组及服用药物信息。紧急情况下确需破盲，由研究者请示所在中心负责人，经中心负责人签字同意后可拆阅应急破盲信件，破盲后24小时内通知临床研究组长单位与申办方。

Blinding：

Adopt a double-blind design. Xinshubao Tablets are prepared by Zhangzhou Pianzhaihuang Pharmaceutical Co. LTD. The main components of Xinshubao Tablet simulation agent are microcrystalline cellulose pigment and dextrin etc. Its appearance size color dosage form weight taste and smell are all the same as those of the test drug and it is produced by Zhangzhou Pianzhaihuang Pharmaceutical Co. LTD. (1) Blinding method: Blinding was set for the researchers and subjects. The blinding work was jointly completed by the head of the clinical research responsible unit the sponsor and the statisticians and a two-level blinding method was adopted. First-level blinding: That is the blinding of the investigational drug. The test drug and the placebo were uniformly packaged while ensuring that there was no difference in appearance between the two groups of drugs. Secondary blinding: That is the numbering of the packaging boxes of the test drugs is blinded. (2) Blind bottom preservation: Personnel unrelated to the clinical observation monitoring statistical analysis etc. of this study shall code the drugs in the experimental group and the control group based on the formed random sequence and the corresponding drug numbers shall be pasted in a prominent position on the external packaging of the drugs. The blinding process should be recorded in writing and signed by all the personnel involved in blinding. The blind base must be sealed on the spot after the drug is blinded and kept in two separate places by the full-time staff of the institution responsible for the clinical research and the sponsor. Emergency letters are sent to each center along with the trial drug for safekeeping by the institution's responsible person until the end of the trial. No one is allowed to keep the blind bottom letters and emergency letters privately. If the blind bottom letters are opened at will it will be regarded as a failure of this clinical trial. If the emergency letters are opened without reason they will be treated as dropped cases. (3) Emergency Letter: Each numbered test drug has a corresponding emergency letter. The emergency letter must indicate the true name of the drug and the test code of the drug. The envelope should be marked with the preservation method of the letter the opening standard and the drug code (the drug label the cover of the emergency envelope and the drug code inside the emergency envelope should all be consistent). (4) Blinding regulations: When patients experience severe adverse reactions/events they need to be grouped for treatment. When the patient has serious complications; Those whose symptoms have worsened and who must take emergency measures; Cases that are withdrawn due to therapeutic effects shall not be blinded. (5) Unblinding procedures: Before unblinding it is advisable to notify the relevant personnel of the principal investigator and the sponsor as much as possible and then conduct emergency unblinding to obtain the specific grouping and medication information of the subjects. In an emergency situation where it is truly necessary to break the blind the researcher should consult the head of the center where they are located. After obtaining the signature of consent from the head of the center they can open the emergency blind break letter. Within 24 hours after the blind break the leading unit of the clinical study and the sponsor should be notified.

是否共享原始数据：

IPD sharing：

否

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）：

共享原始数据：否

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

共享原始数据：否

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：

1. 数据采集方法 1.1病例记录表（CRF） CRF是本临床试验中用于记录受试者信息和研究数据的基本工具。所有参与试验的研究中心均需使用统一的CRF，以确保数据的一致性和完整性。CRF将涵盖以下内容： 受试者基本信息：包括人口学资料（年龄、性别、体重等）、病史、体格检查结果、既往和当前的用药情况等。 试验过程记录：详细记录受试者在试验中的各个阶段，包括筛选期、导入期、治疗期以及随访期的所有相关数据。这将涵盖药物发放与回收情况、治疗依从性评估、所有观察到的不良事件（AE）和严重不良事件（SAE）等。 主要和次要疗效指标：包括心绞痛发作频率的记录、心绞痛应急用药使用量、中医证候积分、实验室检查结果、影像学检查结果等。 终点事件：记录与治疗相关的复合心脑血管终点事件（如心肌梗死、脑卒中、心血管死亡等）的发生情况。 1.2电子数据采集系统（EDC） 本研究将使用ResMan作为EDC系统，用于数据的电子采集、管理和存储。ResMan系统具有以下特点和功能： 数据实时录入：研究者或指定的数据录入人员将在CRF上记录的数据实时录入ResMan系统。系统将要求填写所有必填字段，并提供错误提示，以减少数据录入错误。 数据完整性验证：系统将自动进行逻辑校验和范围检查，确保数据的完整性和一致性。例如，系统将自动识别异常值并提示研究者进行核查和确认。 电子签名和时间戳：所有数据的录入、修改和审核均需通过电子签名和时间戳进行记录，确保数据的可追溯性和研究者的责任归属。 数据安全和保密：ResMan系统将采用多层安全措施，包括网络加密、访问权限控制和数据备份等，以确保受试者数据的安全性和保密性。只有经过授权的研究人员和监查人员能够访问相关数据。 2. 数据管理流程 2.1数据录入与审核 数据录入：数据录入人员将按照CRF的内容，将数据逐项录入ResMan系统。录入过程中，系统将自动校验数据格式和逻辑关系，减少人为错误。 数据审核：数据录入完成后，临床监查员将对录入的数据进行审核，确保数据的准确性和完整性。审核内容包括数据的一致性、完整性、逻辑性等。对于发现的问题或疑问，将及时与研究者沟通并进行修正。 2.2数据修改与管理 数据修改：数据修改必须经过严格的程序，所有修改均需记录修改的具体内容、原因和时间，并由修改人电子签名确认。系统将保留所有修改历史记录，以供后续审计和核查。 数据锁定：在所有数据录入完成并通过审核后，将对数据进行锁定，以确保数据的稳定性和完整性。数据锁定后，未经正式批准，任何数据均不得被修改。 2.3数据备份与恢复 数据备份：ResMan系统将定期对数据进行自动备份，以防止数据丢失。同时，研究团队也将定期对本地数据进行备份，并将备份数据存储在安全的存储设备中。 数据恢复：在发生数据丢失或损坏的情况下，将根据备份数据进行恢复。数据恢复过程将由系统管理员负责，并确保数据恢复的准确性和完整性。 2.4数据访问与共享 数据访问权限：只有经过授权的研究人员、监查员和数据管理人员才能访问ResMan系统中的数据。访问权限将根据研究者的职责和需求进行分级设置，确保数据的安全性和保密性。 数据共享：在符合相关法律法规和伦理要求的前提下，研究团队可能会与申办方、统计分析单位和其他相关机构共享部分或全部数据。数据共享前，将对数据进行脱敏处理，以保护受试者的隐私。 3. 数据质量控制 为了确保数据的质量和可靠性，将采取以下措施进行数据质量控制： 培训与指导：在试验开始前，对所有参与数据采集和管理的研究人员进行系统的培训，确保他们熟悉CRF和EDC系统的使用方法，以及数据采集和管理的要求。 现场监查与审计：监查员将定期对各研究中心进行现场监查，检查CRF的填写情况和数据录入的准确性，及时发现并纠正问题。同时，申办方或第三方审计机构将对数据进行审计，以确保数据的真实性和完整性。 数据质量指标：设定数据质量指标，如数据完整性、准确性、及时性等，并定期对数据质量进行评估。对于发现的数据质量问题，将及时采取措施进行整改。 数据清理：在数据锁定前，将进行全面的数据清理，包括数据一致性检查、逻辑关系校验、重复数据处理等，以确保数据的准确性和完整性。 通过以上数据采集和管理措施，本研究将确保数据的真实、准确、完整和可靠，为临床试验结果的科学性和可信度提供坚实保障。

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

1. Data collection method 1.1 Case Record Form (CRF) CRF is the basic tool used in this clinical trial to record the information of the subjects and the research data. All research centers participating in the trial must use a unified CRF to ensure the consistency and integrity of the data. CRF will cover the following contents: Basic information of the subjects: including demographic data (age gender weight etc.) medical history physical examination results past and current medication use etc. Trial process record: Detailed records of all relevant data of the subjects at each stage of the trial including the screening period introduction period treatment period and follow-up period. This will cover the distribution and retrieval of drugs the assessment of treatment compliance all observed adverse events (AE) and serious adverse events (SAE) etc. Primary and secondary efficacy indicators: including the recording of the frequency of angina pectoris attacks the dosage of emergency medication for angina pectoris the TCM syndrome score laboratory test results imaging examination results etc. Endpoint events: Record the occurrence of complex cardiovascular and cerebrovascular endpoint events related to treatment (such as myocardial infarction stroke cardiovascular death etc.). 1.2 Electronic Data Acquisition System (EDC) This study will use ResMan as the EDC system for the electronic acquisition management and storage of data. The ResMan system has the following characteristics and functions: Real-time data entry: Researchers or designated data entry personnel will enter the data recorded on the CRF into the ResMan system in real time. The system will require all required fields to be filled in and provide error prompts to reduce data entry errors. Data integrity verification: The system will automatically perform logical validation and range checks to ensure the integrity and consistency of the data. For example the system will automatically identify outliers and prompt researchers to conduct verification and confirmation. Electronic signature and timestamp: All data entry modification and review must be recorded through electronic signature and timestamp to ensure the traceability of the data and the attribution of the researcher's responsibility. Data security and confidentiality: The ResMan system will adopt multiple layers of security measures including network encryption access control and data backup to ensure the security and confidentiality of the subjects' data. Only authorized researchers and monitors can access the relevant data. 2. Data management process 2.1 Data Entry and Review Data entry: Data entry personnel will enter the data item by item into the ResMan system in accordance with the content of CRF. During the input process the system will automatically verify the data format and logical relationship to reduce human errors. Data review: After the data entry is completed the clinical monitor will review the entered data to ensure its accuracy and completeness. The review content includes the consistency completeness logic etc. of the data. Any problems or doubts discovered will be communicated with the researchers in a timely manner and corrected. 2.2 Data Modification and Management Data modification: Data modification must go through a strict procedure. All modifications must record the specific content reasons and time of the modification and be confirmed by the electronic signature of the modifier. The system will retain all modification history records for subsequent audits and verifications. Data locking: After all data entry is completed and passed the review the data will be locked to ensure its stability and integrity. After the data is locked no data may be modified without formal approval. 2.3 Data Backup and Recovery Data backup: The ResMan system will automatically back up data on a regular basis to prevent data loss. Meanwhile the research team will also regularly back up local data and store the backup data in secure storage devices. Data recovery: In the event of data loss or damage recovery will be carried out based on the backup data. The data recovery process will be handled by the system administrator who will ensure the accuracy and completeness of the data recovery. 2.4 Data Access and Sharing Data access rights: Only authorized researchers monitors and data managers can access the data in the ResMan system. Access permissions will be set hierarchically based on the researcher's responsibilities and requirements to ensure the security and confidentiality of the data. Data sharing: Under the premise of complying with relevant laws regulations and ethical requirements the research team may share some or all of the data with the sponsor statistical analysis units and other relevant institutions. Before data sharing the data will be desensitized to protect the privacy of the subjects. 3. Data quality control To ensure the quality and reliability of the data the following measures will be taken for data quality control: Training and Guidance: Before the start of the trial systematic training should be provided to all researchers involved in data collection and management to ensure they are familiar with the usage methods of the CRF and EDC systems as well as the requirements for data collection and management. On-site supervision and auditing: Supervisors will conduct regular on-site supervision of each research center to check the filling of CRF and the accuracy of data entry and promptly identify and correct any issues. Meanwhile the sponsor or a third-party auditing institution will audit the data to ensure its authenticity and integrity. Data quality indicators: Set data quality indicators such as data completeness accuracy and timeliness and regularly assess the data quality. For the data quality issues discovered timely measures will be taken to rectify them. Data cleaning: Before data locking a comprehensive data cleaning will be carried out including data consistency checks logical relationship verifications and duplicate data processing to ensure the accuracy and completeness of the data. Through the above data collection and management measures this study will ensure the authenticity accuracy completeness and reliability of the data providing a solid guarantee for the scientificity and credibility of the clinical trial results.

数据管理委员会：

Data Managemen Committee：

有

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):

back
Platform information
About ITMCTR
About Us
Register Trials
Frequently Asked Questions
Ethical Review
The public service
Search Trials
Join Us
ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above