ChiCTR2600126131 版本V1.1 版本创建时间2026/06/04 10:54:54 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600126131 

最近更新日期：

Date of Last Refreshed on：

 2026-06-04 10:54:14 

注册时间：

Date of Registration：

 2026-06-04 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

复方刺五加颗粒对慢性冠心病患者运动能力的RCT研究

Public title：

Ciwujia Granules in Enhancing Exercise Tolerance for Chronic Coronary Heart Disease Patients: A Randomized Double-Blind Controlled Study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

复方刺五加颗粒对提升慢性冠脉综合征患者运动耐力的有效性及安全性研究：一项前瞻性、单中心、随机、双盲、安慰剂对照临床研究

Scientific title：

Efficacy and Safety of Compound Ciwujia Granules in Enhancing Exercise Tolerance in Patients with Chronic Coronary Syndrome: A Prospective, Single-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Study

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：

黄尚玮 

研究负责人：

张奇 

Applicant：

Shangwei Huang 

Study leader：

Qi Zhang 

申请注册联系人电话：

Applicant telephone：

 +86 21 38804518

研究负责人电话：

Study leader's
telephone：

+86 21 38804518

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：

 wave621723@163.com

研究负责人电子邮件：

Study leader's E-mail：

 zq5959@easthospital.cn

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：

上海市浦东新区即墨路150号

研究负责人通讯地址：

上海市浦东新区即墨路150号

Applicant address：

No. 150, Qingmou Road, Pudong New Area, Shanghai

Study leader's address：

No. 150, Qingmou Road, Pudong New Area, Shanghai

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：

上海市东方医院

Applicant's institution：

Shanghai East Hospital

研究负责人所在单位：

上海市东方医院

Affiliation of the Leader：

Shanghai East Hospital

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：

 【2026】研审第(121) 号

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：

上海市东方医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Shanghai Dongfang Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-05-08 00:00:00

伦理委员会联系人：

萧王文

Contact Name of the ethic committee：

Wangwen Xiao

伦理委员会联系地址：

上海市浦东新区即墨路150号

Contact Address of the ethic committee：

No. 150, Qingmou Road, Pudong New Area, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 21 38804518

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 xiaodwm@163.com

研究实施负责（组长）单位：

上海市东方医院

Primary sponsor：

Shanghai East Hospital

研究实施负责（组长）单位地址：

上海市浦东新区即墨路150号

Primary sponsor's address：

No. 150, Qingmou Road, Pudong New Area, Shanghai

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

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海市东方医院

具体地址：

上海市浦东新区即墨路150号

Institution
hospital：

Shanghai East Hospital

Address：

No. 150, Qingmou Road, Pudong New Area, Shanghai

经费或物资来源：

鸡西市生物医药产业“揭榜挂帅”科技攻关项目

Source(s) of funding：

Jixi City Biomedical Industry "Project Revealing and Leading" Scientific and Technological Research

研究疾病：

慢性冠脉综合征  

Target disease：

Chronic Coronary Syndrome

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

主要目的：评估在指南推荐治疗基础上加用复方刺五加颗粒治疗对改善慢性冠脉综合征患者运动耐量的有效性及安全性。 次要目的：（1）评估复方刺五加颗粒对慢性冠脉综合征患者心绞痛症状及睡眠质量改善效果；（2）评估复方刺五加颗粒对慢性冠脉综合征患者主要的心血管不良事件（MACE）发生率的影响。  

Objectives of Study：

Main objective: To evaluate the effectiveness and safety of adding Compound Codonopsis Granules to the recommended treatment in the guidelines for improving the exercise tolerance of patients with chronic coronary syndrome. Secondary objectives: (1) To assess the improvement effect of Compound Codonopsis Granules on angina pectoris symptoms and sleep quality in patients with chronic coronary syndrome; (2) To evaluate the impact of Compound Codonopsis Granules on the incidence of major cardiovascular adverse events (MACE) in patients with chronic coronary syndrome.

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.符合慢性冠脉综合征诊断标准； 2.已严格遵循临床指南推荐方案实施药物治疗，2周内保持原方案稳定治疗且未添加任何中成药物； 3.年龄18~80岁； 4.有能力完成CPET检测； 5.理解并遵守研究程序和方法，自愿参加本研究，并签署知情同意书。

Inclusion criteria

1. Meets the diagnostic criteria for chronic coronary syndrome; 2. Has strictly followed the recommended treatment plan as recommended by clinical guidelines, maintaining the original treatment plan stable within 2 weeks and without adding any traditional Chinese medicine; 3. Age 18 to 80 years old; 4. Capable of undergoing CPET testing; 5. Understands and complies with the research procedures and methods, voluntarily participates in this study, and signs the informed consent form.

排除标准：

1.接受研究药物前3个月内或研究期内计划接受血运重建（如PCI、CABG）、植入式装置（如ICD、CRT等）者或外科手术者； 2.重度心肺功能不全者（NYHA心功能III或IV级；或心脏超声检查左室射血分数（LVEF)<=40%；或肺功能重度异常）； 3.其他CPET检测禁忌症，包括但不限于： （1）心血管疾病如先天性心脏病、中到重度主动脉瓣狭窄或关闭不全、心肌病（如肥厚型梗阻性心肌病、限制性心肌病、扩张型心肌病、酒精性心肌病）、中大量心包积液、缩窄性心包炎、感染性心内膜炎、心肌炎、严重主动脉缩窄或降主动脉瘤、肺动脉高压等； （2）有症状或血液动力学不稳定的严重心律失常，如多源多发室性早搏、频发的短阵室性心动过速、持续性室性心动过速等；严重的缓慢性心律失常，如高度及以上房室传导阻滞(起搏器置入患者除外)； （3）其他急性疾病，如主动脉夹层、肺栓塞及肺梗死、下肢深静脉血栓、肌间静脉血栓、未控制的哮喘、近期卒中或短暂性脑缺血发作等；近期发生可影响运动能力的疾病，或患有可因运动而加剧病情的疾病(如感染、甲状腺毒症)； （4）静息心率>120次/分； （5）高血压控制不良者(治疗后收缩压>=160 mmHg或舒张压>=100 mmHg)或存在低血压情况（收缩压<90mmHg 和/或舒张压<60mmHg）；（6）过去曾在进行运动试验时出现严重ST段压低； 4.筛选时临床实验室检查出现以下任何一项异常，如有必要可重复一次： （1）糖化血红蛋白>=9.5%； （2）丙氨酸氨基转移酶或天冬氨酸氨基转移酶>2x正常值上限； （3）总胆红素>=1.5x正常值上限； （4）根据CKD-EPI公式计算的 eGFR < 40 ml/min/1.73 m^2； （5）血红蛋白Hb＜90g/L； 5.合并预期生存期不足 1 年的恶性肿瘤或其他严重疾病； 6.精神异常或不能配合者； 7.妊娠或哺乳期女性，或在研究首次给药至末次给药后1月内有生育需求； 8.筛选前1个月内或5个半衰期内（以时间更长者为准）接受过其它临床研究用药品或医疗器械治疗者； 9.正在参加其他药物或器械临床研究者； 10.已知对复方刺五加颗粒及其辅料成分过敏者； 11.正在使用其他中成药剂，且无法停用该药者； 12.研究者认为受试者存在不适合入组的任何情况； 13.拒绝签署知情同意书。

Exclusion criteria：

1. Those who planned to undergo revascularization procedures (such as PCI, CABG), implantable devices (such as ICD, CRT, etc.) or surgical operations within 3 months before the study or during the study period; 2. Those with severe cardiac or pulmonary dysfunction (NYHA cardiac function III or IV; or left ventricular ejection fraction (LVEF) <= 40% as determined by echocardiography; or severely abnormal pulmonary function); 3. Other contraindications for CPET testing, including but not limited to: (1) Cardiovascular diseases such as congenital heart disease, moderate to severe aortic valve stenosis or insufficiency, cardiomyopathy (such as hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, dilated cardiomyopathy, alcoholic cardiomyopathy), significant pericardial effusion, constrictive pericarditis, infectious endocarditis, myocarditis, severe aortic coarctation or descending aortic aneurysm, pulmonary hypertension, etc.; (2) Severe arrhythmias with symptoms or hemodynamic instability, such as multiple and multiple premature ventricular contractions, frequent short episodes of ventricular tachycardia, persistent ventricular tachycardia, etc.; severe bradyarrhythmias, such as high-grade and above atrioventricular block (except for patients with pacemaker implantation); (3) Other acute diseases, such as aortic dissection, pulmonary embolism and pulmonary infarction, deep vein thrombosis of the lower extremities, intermuscular vein thrombosis, uncontrolled asthma, recent stroke or transient ischemic attack, etc.; recent diseases that may affect exercise capacity, or having diseases that may be exacerbated by exercise (such as infection, thyrotoxicosis); (4) Resting heart rate > 120 beats per minute; (5) Poorly controlled hypertension (treatment-induced systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg) or hypotension (systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 60 mmHg); (6) Severe ST segment depression occurred during the exercise test in the past; 4. Any abnormality in the clinical laboratory tests during the screening, and a repeat test may be necessary if necessary: (1) Glycated hemoglobin >= 9.5%; (2) Alanine aminotransferase or aspartate aminotransferase > 2 times the upper limit of the normal value; (3) Total bilirubin >= 1.5 times the upper limit of the normal value; (4) eGFR calculated according to the CKD-EPI formula < 40 ml/min/1.73 m^2; (5) Hemoglobin Hb < 90 g/L; 5. Those with an expected survival period of less than 1 year for malignant tumors or other serious diseases; 6. Those with mental abnormalities or unable to cooperate; 7. Pregnant or lactating women, or those with a fertility need within 1 month after the first administration of the study drug to the last administration; 8. Those who have received other clinical research drugs or medical devices within 1 month before screening or within 5 half-lives (whichever is longer); 9. Those who are participating in other drug or device clinical studies; 10. Those who are known to be allergic to Compound Codonopsis Granules and its excipient components; 11. Those who are using other Chinese patent medicines and cannot discontinue the medication; 12. The investigator believes that the subject has any conditions that are not suitable for enrollment; 13. Those who refuse to sign the informed consent form.

研究实施时间：

Study execute time：

从 From 2026-05-15 00:00:00至 To 2028-05-15 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-04 00:00:00 至 To 2028-02-01 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 57

Group：

Control Group

Sample size：

干预措施：

安慰剂

干预措施代码：

Intervention：

Placebo

Intervention code：

组别：

试验组

样本量：

 57

Group：

Experimental Group

Sample size：

干预措施：

复方刺五加颗粒

干预措施代码：

Intervention：

Compound Ciwujia 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 

市(区县)：

  

Country：

China

Province：

Shanghai

City：

单位(医院)：

 上海市东方医院 

单位级别：

 三级甲等 

Institution
hospital：

Shanghai East Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

匹兹堡睡眠评定量表评分

指标类型：

次要指标

Outcome：

Pittsburgh Sleep Quality Index

Type：

Secondary indicator

测量时间点：

治疗前和治疗12周后

测量方法：

匹兹堡睡眠评定量表测试

Measure time point of outcome：

Before treatment and after 12 weeks of treatment

Measure method：

Pittsburgh Sleep Quality Index

指标中文名：

主要心血管事件发生率

指标类型：

次要指标

Outcome：

Incidence Rate of Major Adverse Cardiovascular Events (MACE)

Type：

Secondary indicator

测量时间点：

治疗前和治疗12周后

测量方法：

统计主要心血管事件

Measure time point of outcome：

Before treatment and after 12 weeks of treatment

Measure method：

Statistical Analysis of Major Adverse Cardiovascular Events

指标中文名：

氧脉最大值改善百分比

指标类型：

次要指标

Outcome：

Percentage Improvement in Maximum Oxygen Pulse

Type：

Secondary indicator

测量时间点：

治疗前和治疗12周后

测量方法：

运动心肺试验

Measure time point of outcome：

Before treatment and after 12 weeks of treatment

Measure method：

Cardiopulmonary Exercise Test

指标中文名：

无氧阈值（AT）改善百分比

指标类型：

次要指标

Outcome：

Percentage Improvement in Anaerobic Threshold

Type：

Secondary indicator

测量时间点：

治疗前和治疗12周后

测量方法：

运动心肺试验

Measure time point of outcome：

Before treatment and after 12 weeks of treatment

Measure method：

Cardiopulmonary Exercise Test

指标中文名：

氧脉曲线斜率变化率

指标类型：

次要指标

Outcome：

Rate of Change in Oxygen Pulse Curve Slope

Type：

Secondary indicator

测量时间点：

治疗前和治疗12周后

测量方法：

运动心肺试验

Measure time point of outcome：

Before treatment and after 12 weeks of treatment

Measure method：

Cardiopulmonary Exercise Test

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 Questionnaire Score

Type：

Secondary indicator

测量时间点：

治疗前和治疗12周后

测量方法：

西雅图心绞痛量表测试

Measure time point of outcome：

Before treatment and after 12 weeks of treatment

Measure method：

Seattle Angina Questionnaire

指标中文名：

VO2max与基线相比的改善百分比

指标类型：

主要指标

Outcome：

The percentage improvement of VO2max compared to the baseline

Type：

Primary indicator

测量时间点：

治疗前和治疗12周后

测量方法：

运动心肺试验

Measure time point of outcome：

Before treatment and after 12 weeks of treatment

Measure method：

Cardiopulmonary Exercise Test

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

 使用后保存  

说明

Fate of sample：

Preservation 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 18 岁 years
最大 Max age 80 岁 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）：

本项研究采用区组随机化方法，根据给定随机种子数，由独立于研究团队的第三方随机化专员采用SAS9.4统计软件，按照1:1比例产生受试者所接受治疗组（试验组、对照组）的随机序列。 由随机序列对研究用药分配药物编号。研究者按受试者入组次序，按药物编号由小到大依次发放药物。每位受试者的药物编号是唯一的，在整个研究中保持不变。 申办方应根据随机号准备同等数量的药袋或药盒，药袋或药盒中包含治疗期内所有的用药。

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

This study employs a block randomization approach. Using a predefined random seed number, an independent third-party randomization specialist (external to the research team) generates a random sequence for treatment allocation (experimental group vs. control group) at a 1:1 ratio via SAS 9.4 statistical software. The random sequence assigns unique medication numbers to study drugs. Investigators distribute medications in ascending numerical order based on subject enrollment sequence. Each participant is assigned a unique, unchanging medication number throughout the study. The sponsor must prepare an equal quantity of medication bags/boxes corresponding to the randomization numbers, each containing all required study medications for the entire treatment period.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

双盲，对研究参与者和研究者设盲

Blinding：

Double-blind, with both the research participants and the researchers being blinded.

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）：

无

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

None

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：

本次研究填写的数据载体主要为研究病历、病例报告表、eCRF。原始数据包括病历、实验室检查报告、12导联心电图报告、CPET报告、评定量表、各种研究登记表格以及病例报告表中的量表评定数据等。研究者在诊治受试者的同时填写研究病历及病例报告表，无论是符合研究方案的病例还是脱落病例均需如实填写，并保证数据记录及时、完整、准确、真实。研究病历和病例报告表做任何更正时只能划线，旁注改后的数据，由研究者签名并注明日期，不得擦涂、覆盖原始记录。受试者的全部原始化验单均需粘贴在研究病历上。 本次研究同时采用电子化数据采集（Electronic Data Capture，EDC）管理模式，在研究启动之前对研究参加人员进行相关培训。数据管理员根据研究病历、病例报告表构建eCRF。构建完成后交研究者和申办者审查。一致通过后数据管理员根据研究者提供的信息创建帐号，构建好的 eCRF 进行研究前测试，测试完毕确保无误并记录。临床研究者应指定（授权）数据录入员(或称临床协调员，Clinical Research Coordinator，CRC)。在受试者访视后，录入员应在36-60小时内及时、准确地将研究病历中的数据录入到eCRF上，发现有错误的地方及时更正。 对eCRF中存在的疑问，监查员将随时在线提出疑问，研究者应尽快在线给予解答，修改错误数据，必要时监查员可以重复发出疑问。 在每一位受试者完成研究并经监查员审核无误后，由数据管理员按照SOP流程对数据进行锁定，直至最后一名受试者完成研究。在最后一名受试者完成研究，并完成数据审核和盲态审核后，数据管理员根据数据库锁定流程获得书面批准数据库锁定，并由研究相关人员签名及签署日期，研究相关人员有：数据管理人员、统计师、临床监查员代表、研究者代表等。一旦获得数据库锁定的书面批准文件，就应收回数据库的数据编辑权限，并将收回数据编辑权限的日期记录在文档中。数据全部锁定后，由数据管理员将其导入到指定数据库，交统计人员进行统计分析。 为保证国家药品监督管理局和申办者的评价与监督，研究者应保存所有研究资料，包括对所有受试者的所有医疗记录及相关资料（能有效地核对不同的记录资料，如 eCRF 和医院原始记录、研究病历）。 全部病例无论是观察完成还是脱落，均应按要求完成研究病历、病例报告表和eCRF的填写。研究病历作为原始资料由各参试单位自行存档。病例报告表、eCRF在数据录入完成后，分别由申办者、相关临床研究负责单位分别存档。

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

The data carriers used in this study mainly include research medical records, case report forms, and eCRF. The original data include medical records, laboratory test reports, 12-lead electrocardiogram reports, CPET reports, assessment scales, various research registration forms, and the scale assessment data in the case report forms. The researchers filled in the research medical records and case report forms while treating the subjects. Both the cases that met the research protocol and the dropped-out cases needed to be filled in truthfully, and the data records should be timely, complete, accurate, and true. When making any corrections to the research medical records and case report forms, only lines can be drawn, and the modified data can be noted beside, signed by the researcher and dated. It is not allowed to erase, cover, or alter the original records. All the original test reports of the subjects should be pasted onto the research medical records. This study also adopts the electronic data capture (Electronic Data Capture, EDC) management mode. Before the study starts, relevant training is provided to the study participants. The data administrator builds the eCRF based on the research medical records and case report forms. After the eCRF is constructed, it is reviewed by the researcher and the sponsor. Once it is unanimously approved, the data administrator creates accounts based on the information provided by the researcher, and the constructed eCRF undergoes a pre-study test. After the test, it is ensured to be error-free and recorded. The clinical researchers should appoint (authorize) a data entry clerk (or called Clinical Research Coordinator, CRC). After the subject visit, the entry clerk should promptly and accurately enter the data in the research medical record into the eCRF within 36-60 hours. If there are errors, they should be corrected promptly. For any questions in the eCRF, the monitor will raise questions online at any time. The researcher should answer online as soon as possible, modify the incorrect data, and if necessary, the monitor can repeat the questioning. After each subject completes the study and the monitor verifies it without error, the data administrator locks the data according to the SOP process until the last subject completes the study. After the last subject completes the study and the data is reviewed and blinded by the monitor, the data administrator obtains written approval for database locking based on the database locking process and signs and dates with the relevant research personnel, including data administrators, statisticians, clinical monitor representatives, and researcher representatives. Once the written approval for database locking is obtained, the data editing authority of the database should be recovered and the date of recovery should be recorded in the document. After all the data is locked, the data administrator imports it into the designated database and submits it to the statisticians for statistical analysis. To ensure the evaluation and supervision by the National Medical Products Administration and the sponsor, the researcher should preserve all research materials, including all medical records and related materials of all subjects (which can effectively compare different record materials, such as eCRF and hospital original records, research medical records). Whether the cases are completed or dropped out, all cases should complete the filling of the research medical record, case report form, and eCRF as required. The research medical record serves as the original data and is archived by each participating unit. The case report form and eCRF are archived by the sponsor and the relevant clinical research responsible unit respectively after the data entry is completed.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-06-04 10:54:00