元姜方治疗症状性心动过缓的循证评价研究

注册号:

Registration number:

ITMCTR2023000027

最近更新日期:

Date of Last Refreshed on:

2023-08-09

注册时间:

Date of Registration:

2023-08-09

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

元姜方治疗症状性心动过缓的循证评价研究

Public title:

An evidence-based evaluation study of YuanJiang decoction in the treatment of symptomatic bradycardia

注册题目简写:

English Acronym:

研究课题的正式科学名称:

元姜方治疗症状性心动过缓的循证评价研究

Scientific title:

An evidence-based evaluation study of YuanJiang decoction in the treatment of symptomatic bradycardia

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:

张雪雪

研究负责人:

张菀桐

Applicant:

Zhang Xuexue

Study leader:

Zhang Wantong

申请注册联系人电话:

Applicant telephone:

18324182082

研究负责人电话:

Study leader's telephone:

13311176716

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:

zhangxuexue6666@163.com

研究负责人电子邮件:

Study leader's E-mail:

wantong_zhang@hotmail.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:

北京市海淀区西苑操场1号

研究负责人通讯地址:

北京市海淀区西苑操场1号

Applicant address:

No. 1, xiyuan playground, Zhong Zhi Road, Hai Dian District, Beijing

Study leader's address:

No. 1, xiyuan playground, Zhong Zhi Road, Hai Dian District, Beijing

申请注册联系人邮政编码:

Applicant postcode:

100091

研究负责人邮政编码:

Study leader's postcode:

100091

申请人所在单位:

中国中医科学院西苑医院

Applicant's institution:

Xiyuan Hospital, China Academy of Chinese Medical Sciences

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:

2023XLA077-3

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:

中国中医科学院西苑医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2023/7/28 0:00:00

伦理委员会联系人:

訾明杰

Contact Name of the ethic committee:

ZI Mingjie

伦理委员会联系地址:

北京市海淀区西苑操场1号

Contact Address of the ethic committee:

No. 1, xiyuan playground, Zhong Zhi Road, Hai Dian District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-62835646

伦理委员会联系人邮箱:

Contact email of the ethic committee:

XiyuanLunli@126.com

研究实施负责(组长)单位:

中国中医科学院西苑医院

Primary sponsor:

Xiyuan Hospital, China Academy of Chinese Medical Sciences

研究实施负责(组长)单位地址:

北京市海淀区西苑操场1号

Primary sponsor's address:

No. 1, xiyuan playground, Zhong Zhi Road, Hai Dian District, Beijing

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

海淀区

Country:

Cina

Province:

Beijing

City:

Hai Dian District

单位(医院):

中国中医学院西苑医院

具体地址:

北京市海淀区西苑操场1号

Institution
hospital:

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Address:

No. 1, xiyuan playground, Zhong Zhi Road, Hai Dian District, Beijing

经费或物资来源:

国家中医心血管病临床医学研究中心专项科研基金

Source(s) of funding:

Scientific Fund of National Clinical Research Center for Chinese Medicine Cardiology

研究疾病:

症状性心动过缓

研究疾病代码:

Target disease:

Symptomatic bradycardia

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:

其它

Others

研究目的:

评价元姜方治疗症状性心动过缓的有效性及安全性,探索元姜方的疗效特色与优势

Objectives of Study:

Evaluating the efficacy and safety of YuanJiang decoction in the treatment of symptomatic bradycardia and exploring the efficacy features and advantages of YuanJiang decoction

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.符合窦房结功能障碍或房室传导阻滞的诊断标准; 2.患者出现 相应的临床症状 如头晕、 黑朦 、乏力、心悸、 胸闷 等,且考虑症状发作与心动过缓明确相关; 3.符合起搏器植入指征,但拒绝起搏治疗; 4.符合阳虚血瘀证型标准; 5.年龄 18 至 80 岁; 6.愿意参与本次研究,签署知情同意书。

Inclusion criteria

1. Patients who meet the diagnostic criteria for SND or AVB; 2. Patients presenting with corresponding clinical symptoms such as dizziness, blurred vision, fatigue, palpitations, chest tightness, etc., and where the onset of symptoms is clearly related to bradycardia; 3. Individuals who meet the indications for pacemaker implantation but have declined pacemaker treatment; 4. Patients who conform to the criteria for Yang-deficiency and blood stasis syndrome in TCM; 5. Age between 18 and 80 years old; 6. Willingness to participate in the study and provide informed consent.

排除标准:

1. 动态心电图提示最长 R R 间期 5s 或最小心率 35 次 分 2.合并 III 度或 高度房室传导阻滞 3.既往因心动过缓 出现过晕厥 4. 患有严重的心、肺、脑、血液系统疾病,包括但不限于急性心肌梗死后 2 周内、不 稳定型心绞痛、 室速、室颤、 药物控制不佳的高血压患者 5.药物引起的短暂性继发性心动过缓 6.心率低但窦房结功能正常的运动员或无心律失常相关症状的运动员 7.甲状腺功能减退导致的心动过缓 8. 怀孕或哺乳期妇女 9. 患有精神疾病及吸毒者 10. 凝血功能障碍 11. 对试验药物过敏 12.近一个月参加了其他心律失常相关临床试验 13.经研究者判断处于其他无法达到研究要求的状态 。

Exclusion criteria:

1. Individuals with a maximum RR interval greater than 5 seconds or a minimum heart rate of 35 beats on a 24-hour ambulatory electrocardiogram; 2. Patients with third-degree or high-degree atrioventricular block; 3. Previous history of syncope due to bradycardia; 4. Patients with severe cardiac, pulmonary, cerebral, or hematologic disorders, including but not limited to those conditions such as acute myocardial infarction within the last 2 weeks, unstable angina, ventricular tachycardia, ventricular fibrillation, and poorly controlled hypertension; 5. Transient secondary bradyarrhythmia caused by medications; 6. Athletes with low heart rate but normal sinus node function or athletes without arrhythmia-related symptoms 7. Bradycardia caused by hypothyroidism; 8. Pregnant or lactating women 9. Patients with mental illness and substance abuse; 10. Coagulation disorders; 11. Allergic predisposition or known allergy to any of the 6 herbs used in the TJT; 12. Participation in other clinical trials within the last month; 13.Other condition that unable to meet the requirements of the study as judged by the researcher.

研究实施时间:

Study execute time:

From 2023-09-01

To      2026-09-01

征募观察对象时间:

Recruiting time:

From 2023-09-01

To      2026-05-01

干预措施:

Interventions:

组别:

治疗组

样本量:

43

Group:

Treatment group

Sample size:

干预措施:

元姜方

干预措施代码:

Intervention:

YuanJiang decoction

Intervention code:

组别:

对照组

样本量:

43

Group:

Control group

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

样本总量 Total sample size : 86

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

北京市

市(区县):

海淀区

Country:

China

Province:

Beijing

City:

Haidian District

单位(医院):

中国中医科学院西苑医院

单位级别:

三级甲等中医医院

Institution/hospital:

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Level of the institution:

Grade 3 Class A Chinese Medicine Hospital

测量指标:

Outcomes:

指标中文名:

肝肾功能、血尿常规

指标类型:

副作用指标

Outcome:

liver function, renal function, blood routine, and urine routine examinations

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量评价 (SF-36)

指标类型:

次要指标

Outcome:

the MOS 36-Item Short-Form Health Survey

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心率变异性

指标类型:

次要指标

Outcome:

heart rate variability

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血浆神经递质

指标类型:

次要指标

Outcome:

plasma neurotransmitters

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

单个核细胞Bmal1和Clock蛋白

指标类型:

次要指标

Outcome:

Bmal1 and Clock in peripheral blood mononuclear cells

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗有效率

指标类型:

主要指标

Outcome:

treatment efficacy rate

Type:

Primary indicator

测量时间点:

测量方法:

1.Holter提示 HRmin 至少增加 5bpm ,或/和 HRmin 超过 40bpm;2.symptom specific VAS 评分较疗前改变≥ 13 毫米,同时满足第1及第2项定义为有效

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

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:

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:

征募研究对象情况:

尚未开始

Not yet 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):

由中国中医科学院西苑医院GCP中心有关人员通过随机数表法产生随机序列

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

The-Random sequences are generated by the GCP Center of Xiyuan Hospital of China Academy of Chinese Medical Sciences through the random number table method.

盲法:

药物现场编盲由随机化编制单位编盲人员和申办单位与本试验无关人员参加,将已形成的药物编号粘贴在标签上。编盲过程形成编盲记录并保存。

Blinding:

The blinded personnel of the randomized preparation unit and the sponsor unit who are not related to this trial participated in the field blinding of the drug, and the drug number was pasted on the label. The blinding process forms blinding records and saves them.

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):

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:

病历记录表

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

Case Record Form, CRF

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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