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Study on the clinical effect and potential mechanism of Sheng-mai Jiu-xin Decoction on Chronic heart failure with qi-yin deficiency yang deficiency and blood stasis

注册号：

Registration number：

ITMCTR2025001057

最近更新日期：

Date of Last Refreshed on：

2025-05-28

注册时间：

Date of Registration：

2025-05-28

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

生脉救心汤治疗气阴两虚阳虚血瘀型慢性心力衰竭的临床疗效和机制研究

Public title：

Study on the clinical effect and potential mechanism of Sheng-mai Jiu-xin Decoction on Chronic heart failure with qi-yin deficiency yang deficiency and blood stasis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

生脉救心汤治疗气阴两虚阳虚血瘀型慢性心力衰竭的临床疗效和机制研究

Scientific title：

Study on the clinical effect and potential mechanism of Sheng-mai Jiu-xin Decoction on Chronic heart failure with qi-yin deficiency yang deficiency and blood stasis

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：

许欣颖

研究负责人：

许欣颖

Applicant：

Xinying Xu

Study leader：

Xinying Xu

申请注册联系人电话：

Applicant telephone：

13405589720

研究负责人电话：

Study leader's telephone：

13405589720

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：

960035724@qq.com

研究负责人电子邮件：

Study leader's E-mail：

960035724@qq.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：

江苏省无锡市滨湖区中南西路8号无锡市中医医院

研究负责人通讯地址：

江苏省无锡市滨湖区中南西路8号无锡市中医医院

Applicant address：

Wuxi Hospital of Traditional Chinese Medicine No. 8 Zhongnan West Road Wuxi Jiangsu China

Study leader's address：

Wuxi Hospital of Traditional Chinese Medicine No. 8 Zhongnan West Road Wuxi Jiangsu China

申请注册联系人邮政编码：

Applicant postcode：

214000

研究负责人邮政编码：

Study leader's postcode：

214000

申请人所在单位：

南京中医药大学附属无锡医院

Applicant's institution：

Nanjing University of Chinese Traditional Medicine

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(研）-043-01

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：

无锡市中医医院伦理委员会

Name of the ethic committee：

IRB of Wuxi Hospital of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2024/4/18 0:00:00

伦理委员会联系人：

沈燕菊

Contact Name of the ethic committee：

Yanju Shen

伦理委员会联系地址：

江苏省无锡市滨湖区中南西路8号无锡市中医医院

Contact Address of the ethic committee：

Wuxi Hospital of Traditional Chinese Medicine No. 8 Zhongnan West Road Wuxi Jiangsu China

伦理委员会联系人电话：

Contact phone of the ethic committee：

051082703775

伦理委员会联系人邮箱：

Contact email of the ethic committee：

1026035118@qq.com

研究实施负责（组长）单位：

无锡市中医医院

Primary sponsor：

Wuxi Hospital Nanjing University of Chinese Medicine

研究实施负责（组长）单位地址：

江苏省无锡市滨湖区中南西路8号无锡市中医医院

Primary sponsor's address：

No.8 West Zhongnan Road Binhu District

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏省

市(区县)：

无锡市

Country：

China

Province：

Jiangsu Province

City：

Wuxi

单位(医院)：

无锡市中医医院

具体地址：

滨湖区中南西路8号

Institution
hospital：

Wuxi Hospital Nanjing University of Chinese Medicine

Address：

No.8 West Zhongnan Road Binhu District

经费或物资来源：

自筹

Source(s) of funding：

self-determination

研究疾病：

心力衰竭

研究疾病代码：

ICD-11:BD1Z

Target disease：

heart failure

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：

探索性研究/预试验

Pilot clinical trial

研究目的：

通过一项随机、对照临床试验验证生脉救心汤对气阴两虚阳虚血瘀型慢性心力衰竭患者的临床疗效。通过网络药理学分析、实时荧光定量逆转录PCR（RT-PCR)、酶联免疫吸附法（ELISA）、代谢组学等方法初步探索生脉救心汤治疗慢性心力衰竭的作用机制。

Objectives of Study：

A randomized controlled clinical trial was conducted to validate the clinical efficacy of Shengmaijiuxin Decoction in patients with chronic heart failure of the qi and yin deficiency and yang deficiency and blood stasis type. The mechanism of action of Shengmaijiuxin Decoction in the treatment of chronic heart failure was preliminarily explored by network pharmacological analysis real-time fluorescence quantitative reverse transcription PCR (RT-PCR) enzyme-linked immunosorbent assay (ELISA) metabolomics and other methods.

药物成份或治疗方案详述：

西医对照组予以西医常规治疗，参照《中国心力衰竭诊断和治疗指南2018》主要包括： ①一般治疗：健康宣教，强调限钠、容量管理、低脂饮食、控制体重、适当活动、心理健康教育等； ②祛除危险及诱发因素：如控制感染、纠正电解质紊乱、纠正心律失常、贫血等； ③治疗既往基础疾病：合并房颤、高血压病、２型糖尿病、冠状动脉粥样硬化性心脏病的患者，按照各自的诊疗规范予以相应的治疗，如控制血压、血糖、抗血小板聚集、调脂稳斑、抗动脉硬化等治疗； ④基础西药治疗，包括： ACEI/ARNI：其中ARNI类药物使用沙库巴曲缬沙坦钠片（商品名：诺欣妥，初始剂量为50mg，一天两次，病人未出现不可耐受的副作用及不良反应，逐渐增加剂量，最大长期维持剂量不超过200mg，一天两次）； β受体阻滞剂：琥珀酸美托洛尔缓释片（商品名：倍他乐克，初始剂量为23.75mg，一天一次，病人未出现不可耐受的副作用及不良反应，剂量每两周倍增，最大长期维持剂量不超过190mg，一天一次）； 醛固酮受体拮抗剂（螺内酯片）及利尿剂（呋塞米片）等。（根据患者心率、血压、尿量等情况调整用药方法及剂量）。 钠-葡萄糖协同转运蛋白2抑制剂：达格列净片（5 mg/片，根据患者血压、体重、血容量、血糖、肾功能等因素调整剂量）。 中医治疗组在西医标准治疗的基础上加用生脉救心汤，并根据患者的具体情况加减。中药由无锡市中医医院制剂室代煎至每剂200ml。 生脉救心汤组成如下： 生黄芪30g，麦冬10g，人参10g，红景天15g，生五味子20g，黑顺片5g，干姜5g，炙甘草5g，山萸肉15g，生龙骨30g。 用法：水煎服，每日一剂，早晚两次饭后温服。 治疗周期：8周。

Description for medicine or protocol of treatment in detail：

The Western medicine control group is treated with conventional Western medicine referring to the China Heart Failure Diagnostic and Treatment Guidelines 2018 which mainly includes: ① General treatment: health education emphasizing sodium restriction volume management low-fat diet weight control appropriate activities mental health education etc.; ② Elimination of risk and predisposing factors: such as controlling infections correcting electrolyte disorders correcting cardiac arrhythmia anemia etc.; ③ Treatment of previous underlying diseases: Combined with atrial fibrillation hypertension type 2 diabetes coronary atherosclerotic heart disease patients in accordance with their respective diagnostic and therapeutic specifications to be the appropriate treatment such as control of blood pressure blood glucose antiplatelet aggregation lipid stabilization anti-atherosclerosis and other treatments; ④ basic Western drug therapy including: ACEI / ARNI: which ARNI class of drugs using sarcoplasmic retroviral vasartan sodium tablets (trade name: Nosintocin. The initial dose is 50mg twice a day the patient did not develop intolerable side effects and adverse reactions gradually increase the dose the maximum long-term maintenance dose does not exceed 200mg twice a day);  β-blocker: Metoprolol succinate extended-release tablets (trade name: Betalol the initial dose is 23.75mg Once a day the patient did not experience intolerable side effects and adverse reactions the dose is doubled every two weeks the maximum long-term maintenance dose does not exceed 190 mg once a day);  aldosterone receptor antagonists (spironolactone tablets) and diuretics (furosemide tablets) etc.. (Adjust the method and dose of medication according to the patient's heart rate blood pressure and urine output). Sodium-glucose co-transporter protein 2 inhibitor: dagliflozin tablets (5 mg/tablet adjust the dose according to the patient's blood pressure body weight blood volume blood glucose kidney function and other factors). The Chinese medicine treatment group was treated with Shengmai Jiuxin Decoction on the basis of the standard treatment of Western medicine and the dosage was added or subtracted according to the specific conditions of the patients. The Chinese medicine was decocted by the preparation room of Wuxi Hospital of Traditional Chinese Medicine to 200 ml per dose. The composition of Shengmai Jiuxin Decoction was as follows: raw Astragalus 30g Ophiopogon 10g Panax ginseng 10g Rhodiola rosea 15g raw Schisandra chinensis 20g Heishun tablets 5g dried ginger 5g sizzling licorice 5g Cornu Cervi Pantotrichum 15g raw keel bone 30g. Method of use: decocted with water and served as one dose per day twice a day morning and evening after meals and warmly taken. Treatment cycle: 8 weeks.

纳入标准：

1: 年龄 18-85岁 2: 符合西医诊断标准的慢性心力衰竭患者，中医诊断标准符合心衰病气阴两虚阳虚血瘀证的诊断标准 3: 纽约心脏协会（NYHA）心功能分级为Ⅱ-IV级 4: 能行超声心动图检查及6 min 步行试验（6MWT） 5: 无精神障碍且能够配合调查者 6: 自愿参加本课题研究，并签署知情同意书者

Inclusion criteria

1: Age 18-85 years old; 2: Patients with chronic heart failure who meet the diagnostic criteria of Western medicine and the diagnostic criteria of Chinese medicine meet the diagnostic criteria of Heart Failure Disease with Qi and Yin deficiency and Yang deficiency and blood stasis; 3: New York Heart Association (NYHA) cardiac function class II-IV; 4: Ability to perform echocardiography and 6-min walk test (6MWT); 5: Those without mental disorder and able to cooperate with the investigation; 6: Voluntarily participate in the study and sign an informed consent form.

排除标准：

1: 12周内植入心脏复律除颤器或实施心脏再同步化治疗者 2: 合并急性冠脉综合征（30d内）、心源性休克、急性心肌炎、难以控制的恶性心律失常、肥厚梗阻性心肌病、缩窄性心包炎、心包填塞、严重瓣膜病需要手术治疗及肺动脉栓塞者等；甲状腺功能亢进、贫血、重度肺动脉高压、先天性心脏病等原因导致的心衰 3: 合并心、肝、肾、造血、代谢系统等严重原发性疾病，恶性肿瘤、黄疸、肝肾功能不全者 4: 合并急性感染者 5: 人类免疫缺陷病毒（HIV）抗体阳性者，梅毒检测阳性者，乙型肝炎及丙型肝炎患者 6: 因洋地黄类药物中毒所导致的心衰症状加重者 7: 计划妊娠、妊娠期或哺乳期妇女 8: 怀疑或确有酒精、药物滥用者 9: 过敏体质或对2种以上食物或药物过敏者，或对试验药物及其原辅料成分过敏者 10: 近2个月内参加其他研究者

Exclusion criteria：

1: Those who have implanted cardioverter-defibrillator or performed cardiac resynchronization therapy within 12 weeks 2: Combined acute coronary syndrome (within 30d) cardiogenic shock acute myocarditis difficult to control malignant arrhythmia hypertrophic obstructive cardiomyopathy constrictive pericarditis pericardial tamponade severe valvular disease requiring surgical intervention and pulmonary artery embolism etc.; hyperthyroidism anemia severe pulmonary hypertension congenital heart disease and other causes of heart failure; 3: Those with combined serious primary diseases of heart liver kidney hematopoietic and metabolic systems malignant tumors jaundice liver and kidney insufficiency; 4: Those with combined acute infections; 5: People with positive antibody of human immunodeficiency virus (HIV) people with positive syphilis test patients with hepatitis B and C; 6: Those with worsening heart failure symptoms caused by digitalis drug intoxication 7: Women who are planning to become pregnant pregnant or breastfeeding; 8: People with suspected or confirmed alcohol and drug abuse; 9: Allergic or allergic to more than 2 kinds of food or drugs or allergic to the test drug and its raw ingredients; 10: Those who have participated in other studies within the last 2 months.

研究实施时间：

Study execute time：

从From 2024-04-23

至To      2025-02-01

征募观察对象时间：

Recruiting time：

从From 2024-04-23

至To      2025-02-01

干预措施：

Interventions：

组别：

西医标准治疗组

样本量：

35

Group：

Western medicine standard treatment group

Sample size：

干预措施：

予以西医常规治疗，参照《中国心力衰竭诊断和治疗指南2024》，主要包括： ①一般治疗； ②祛除危险及诱发因素； ③治疗既往基础疾病； ④基础西药治疗，包括：ACEI/ARNI、β受体阻滞剂、醛固酮受体拮抗剂、利尿剂、钠-葡萄糖协同转运蛋白2抑制剂。

干预措施代码：

Intervention：

It should be treated with conventional Western medicine, referring to the Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2024, which mainly includes: ① General treatment; ② Removal of risk and predisposing factors; ③Treatment of previous underlying diseases; ④ Basic western drug therapy, including: ACEI/ARNI, β-blockers, aldosterone receptor antagonists, diuretics, sodium-glucose co-transporter protein 2 inhibitors.

Intervention code：

组别：

中药干预组

样本量：

35

Group：

Chinese medicine intervention group

Sample size：

干预措施：

中医治疗组在西医标准治疗的基础上加用生脉救心汤治疗8周，并根据患者的具体情况加减。中药由无锡市中医医院制剂室代煎至每剂200ml，每日一剂，早晚两次饭后温服。

干预措施代码：

Intervention：

The Chinese medicine treatment group was treated for 8 weeks with Shengmai-Jiuxin Decoction on the basis of the standard treatment of western medicine, and the treatment was added or subtracted according to the specific conditions of the patients. The Chinese medicine was decocted by the preparation room of Wuxi Hospital of Traditional Chinese Medicine to 200 ml per dose, one dose per day, twice in the day and warmly taken after meals.

Intervention code：

样本总量 Total sample size ： 70

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

江苏省

市(区县)：

无锡市

Country：

China

Province：

Jiangsu Province

City：

Wuxi

单位(医院)：

无锡市中医医院

单位级别：

三级甲等

Institution/hospital：

Wuxi Hospital of Traditional Chinese Medicine

Level of the institution：

grade 3A

测量指标：

Outcomes：

指标中文名：

左室射血分数

指标类型：

次要指标

Outcome：

left ventricular ejection fraction

Type：

Secondary indicator

测量时间点：

治疗前、治疗后

测量方法：

患者治疗前、治疗后分别在无锡市中医医院彩超室测量

Measure time point of outcome：

Before treatment After treatment

Measure method：

Patients were measured in the color ultrasound room of Wuxi Hospital of Traditional Chinese Medicine before and after treatment respectively

指标中文名：

血清电解质（钾、钠、氯）

指标类型：

次要指标

Outcome：

Serum electrolytes (potassium sodium chloride)

Type：

Secondary indicator

测量时间点：

治疗前、治疗后

测量方法：

分别在治疗前后抽取患者空腹血，由无锡市中医医院检验科检测分析

Measure time point of outcome：

Before treatment After treatment

Measure method：

Fasting blood samples were collected from patients before and after treatment and tested and analyzed by the Laboratory Department of Wuxi Hospital of Traditional Chinese Medicine.

指标中文名：

人血清单磷酸腺苷激活的蛋白激酶

指标类型：

次要指标

Outcome：

Serum human AMP-activated Protein Kinase

Type：

Secondary indicator

测量时间点：

治疗前、治疗后

测量方法：

酶联免疫吸附试验

Measure time point of outcome：

Before treatment After treatment

Measure method：

Enzyme-Linked Immunosorbent Assay

指标中文名：

六分钟步行试验

指标类型：

次要指标

Outcome：

Six-minute walk test

Type：

Secondary indicator

测量时间点：

治疗前、治疗后

测量方法：

研究者对患者进行试验并评分

Measure time point of outcome：

Before treatment After treatment

Measure method：

Researchers tested and scored patients

指标中文名：

人血清微管相关蛋白1轻链3 beta

指标类型：

次要指标

Outcome：

Serum human microtubule-associated protein 1 light chain 3 beta

Type：

Secondary indicator

测量时间点：

治疗前、治疗后

测量方法：

酶联免疫吸附试验

Measure time point of outcome：

Before treatment After treatment

Measure method：

Enzyme-Linked Immunosorbent Assay

指标中文名：

心功能分级（NYHA）

指标类型：

主要指标

Outcome：

New York Cardiac Function Classification

Type：

Primary indicator

测量时间点：

治疗前、治疗后

测量方法：

由研究者根据患者症状进行评级

Measure time point of outcome：

Before treatment After treatment

Measure method：

Rated by investigators based on patient symptoms

指标中文名：

3个月心血管不良事件MACE发生率

指标类型：

次要指标

Outcome：

3-month incidence of adverse cardiovascular events MACE

Type：

Secondary indicator

测量时间点：

治疗后三月内随访

测量方法：

通过查阅病历系统及电话随访的方式完成

Measure time point of outcome：

Follow-up within three months after treatment

Measure method：

Completed through review of the medical record system and telephone follow-ups

指标中文名：

中医证候积分

指标类型：

次要指标

Outcome：

Traditional Chinese Medicine Syndrome Points

Type：

Secondary indicator

测量时间点：

治疗前、治疗后

测量方法：

研究者通过望闻问切等方法，根据病人实际情况评分

Measure time point of outcome：

Before treatment After treatment

Measure method：

Researchers use methods such as observation listening questioning and cutting to score patients based on their actual conditions.

指标中文名：

人血清沉默调节蛋白1

指标类型：

次要指标

Outcome：

Serum human silencing regulatory protein 1

Type：

Secondary indicator

测量时间点：

治疗前、治疗后

测量方法：

酶联免疫吸附试验

Measure time point of outcome：

Before treatment After treatment

Measure method：

Enzyme-Linked Immunosorbent Assay

指标中文名：

N末端B型利钠肽前体

指标类型：

主要指标

Outcome：

N-terminal pro-brain natriuretic peptide，NT-proBNP

Type：

Primary indicator

测量时间点：

治疗前、治疗后

测量方法：

分别在治疗前后抽取患者空腹血，由无锡市中医医院检验科检测分析

Measure time point of outcome：

Before treatment After treatment

Measure method：

Fasting blood samples were collected from patients before and after treatment and tested and analyzed by the Laboratory Department of Wuxi Hospital of Traditional Chinese Medicine.

指标中文名：

血生化（肌酐、尿酸、肝肾功能、血糖）

指标类型：

次要指标

Outcome：

blood biochemistry (creatinine uric acid liver and kidney function blood glucose)

Type：

Secondary indicator

测量时间点：

治疗前、治疗后

测量方法：

分别在治疗前后抽取患者空腹血，由无锡市中医医院检验科检测分析

Measure time point of outcome：

Before treatment After treatment

Measure method：

Fasting blood samples were collected from patients before and after treatment and tested and analyzed by the Laboratory Department of Wuxi Hospital of Traditional Chinese Medicine.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血清

组织：

Sample Name：

blood serum

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：

结束

Completed

年龄范围：

最小 18 岁
Min age years
最大 85 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）：

简单随机 由研究人员采用随机数字表法产生随机数列

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

Simple Random Generated by the researcher using the random number table method to generate random number series

盲法：

Blinding：

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）：

通过ResMan临床试验公共管理平台获取数据，“http://www.medresman.org.cn/uc/index.aspx”

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

no

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：

数据采集和管理由两部分组成，一为电子采集和管理系统(Electronic Data Capture, EDC），二为病例记录表(Case Record Form, CRF)

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

Data capture and management consists of two components the Electronic Data Capture and Management System (EDC) and the Case Record Form (CRF).

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):

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