循经取穴针刺干预慢性稳定型心绞痛的临床研究

注册号:

Registration number:

AMCTR-IOR-19000309 

注册号获得时间:

Date of releasing the registration number:

2019/11/3 22:56:24 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

循经取穴针刺干预慢性稳定型心绞痛的临床研究 

Public title:

Acupuncture for chronic stable angina pectoris at acupoints on the involved meridian: a multi-center, randomized, controlled trial 

研究课题的正式科学名称:

基于经脉‘体表-内脏’联系的循经针刺效应的临床评价 

Scientific title:

Clinical evaluation of acupuncture effects based on the theory of Meridian-Viscera Association 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

何昭璇 

研究负责人:

曾芳 

Applicant:

He Zhaoxuan 

Study leader:

Zeng Fang 

申请注册联系人电话:

Applicant telephone:

+86 15208265237 

研究负责人电话:

Study leader's telephone:

+86 18602839325 

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:

hezhaoxuan@cdutcm.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

zeng_fang@126.com 

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:

中国四川省成都市十二桥路37号 

研究负责人通讯地址:

中国四川省成都市十二桥路37号 

Applicant address:

37 Shierqiao Road, Chengdu, Sichuan, China 

Study leader's address:

37 Shierqiao Road, Chengdu, Sichuan, 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:

成都中医药大学针灸推拿学院 

Applicant's institution:

Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine 

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:

2019KL-026 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

成都中医药大学附属医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of the Teaching Hospital of Chengdu University of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-07-02 

研究实施负责(组长)单位:

成都中医药大学 

Primary sponsor:

Chengdu University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

中国四川省成都市十二桥路37号 

Primary sponsor's address:

37 Shierqiao Road, Chengdu, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

成都中医药大学

具体地址:

十二桥路37号

Institution
hospital:

Chengdu University of Traditional Chinese Medicine

Address:

37 Shierqiao Road

经费或物资来源:

国家重点研发计划(NO. 2018YFC1704605 ) 

Source(s) of funding:

National Key Research and Development Program ( NO2018YFC1704605) 

研究疾病:

慢性稳定型心绞痛 

Target disease:

chronic stable angina pectoris 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

本试验将评估针刺心经穴位与肺经穴位治疗慢性稳定型心绞痛(chronic stable angina pectoris,CSAP)的疗效差异,为针刺治疗CSAP提供更好的针灸处方依据。 

Objectives of Study:

This trial aims to evaluate the different efficacy of acupuncture at acupoints on the Heart meridian versus acupoints on the Lung meridian for treating chronic stable angina pectoris (CSAP) so as to provide a better prescription for acupuncture treatment of CSAP 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1. 符合中华医学会心血管病学分会冠心病稳定性心绞痛的诊断标准; 2. 符合加拿大心血管学会(CCS)心绞痛严重程度分级标准中的I级或II级; 3. 45岁≤年龄≤70岁; 4. 发病时间3个月及其以上,且近一个月每周发作次数大于或等于2次; 5. 入组前至少2个月的标准基础药物治疗史(维持相同的药物、用法和剂量)。基础治疗药物是一下一种或多种:β-受体阻滞剂,血管紧张素转换酶抑制剂(ACEI),血管紧张素Ⅱ受体拮抗剂(ARB),抗血小板药物和他汀类药物; 6. 依从性好,愿意配合研究,患者签署知情同意书。 

Inclusion criteria

1. Matching the diagnostic criteria of CSAP according to the Chinese Society of Cardiology; 2. Meeting Class I or II of the Canadian Cardiovascular Society (CCS) angina pectoris severity grade; 3. Aging from 45 to 70 years; 4. Having experienced angina attack in at least the last three months, and the attack frequency >= twice a week in the most recent month; 5. At least 2 months of standardized medication history before enrolment (sustaining the same medication, usage, and dose). Basic therapeutic drug is one or more of the following: β-blockers, angiotensin converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers(ARB), antiplatelet medications and statins; 6. Having signed informed consent. 

排除标准:

1. 孕妇及哺乳期妇女、近半年有生育要求者; 2. 合并有心血管、消化、泌尿、呼吸、血液、神经、内分泌系统等严重原发性疾病临床未能有效控制病情者; 3. 转为急性冠状动脉综合征(包括急性心肌梗死和不稳定型心绞痛),严重的心律失常(晚期房室传导阻滞,室性心动过速,室上性心动过速,频繁早搏); 4. 伴严重精神疾病及智力障碍不能配合问卷调查者; 5. 未能控制高血压(收缩压≥140mmHg和/或舒张压≥90mmHg)或糖尿病(HbA1在过去三个月内高于7%)者; 6. 在过去1个月内因心血管疾病曾接受针灸治疗; 7. 有出血倾向及皮肤病患者; 8. 过敏体质及对胶布过敏者; 9. 正在参加其他临床试验者。 

Exclusion criteria:

1. Being pregnant or during lactation or intending to be pregnant in the 6 months; 2. Having severe cardiovascular, digestive, urinary, respiratory, hematological, nervous, or endocrine system diseases that cannot be controlled with clinical treat-ments; 3. Converting to acute coronary syndrome (including acute myocardial infarction and unstable angina pectoris), serious arrhythmia (advanced atrioventricular block, ventricular tachycardia, supraventricular tachycardia, frequent premature beats); 4. Being accompanied with serious psychiatric illness; 5. Failing to control hypertension (systolic blood pressure >= 140 mm Hg and/or diastolic blood pressure >= 90 mm Hg) or diabetes mellitus (HbA1 above 7% in last three months); 6. Having received acupuncture therapy due to cardiovascular illness in the last 1 month; 7. Having bleeding tendency and dermatitis; 8. Being in allergic constitution and be allergic to adhesive tape; 9. Participating in any other clinical trials. 

研究实施时间:

Study execute time:

From2018-12-01To 2021-12-31 

干预措施:

Interventions:

组别:

循心经取穴组

样本量:

74

Group:

acupoints on the Heart meridian group

Sample size:

干预措施:

揿针针刺双侧神门、阴郄、通里、心俞、巨阙,4天1次,共7次

干预措施代码:

Intervention:

acupuncture at acupoints on the Heart meridian with press needles

Intervention code:

组别:

循肺经取穴组

样本量:

74

Group:

acupoints on the Lung meridian group

Sample size:

干预措施:

揿针针刺双侧太渊、列缺、孔最、心俞、巨阙,4天1次,共7次

干预措施代码:

Intervention:

acupuncture at acupoints on the Lung meridian with press needles

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

成都中医药大学 

单位级别:

三级甲等 

Institution
hospital:

成都中医药大学附属医院  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zejiang 

City:

Hangzhou 

单位(医院):

浙江中医药大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Zhejiang Chinese Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

4周内心绞痛发作的频率

指标类型:

主要指标 

Outcome:

The frequency of angina attack during 4-week

Type:

Primary indicator 

指标中文名:

心绞痛的严重程度(VAS评分)

指标类型:

次要指标 

Outcome:

visual analogue scale

Type:

Secondary indicator 

指标中文名:

心肌缺血总负荷

指标类型:

次要指标 

Outcome:

total ischemia burden

Type:

Secondary indicator 

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 

指标中文名:

Q-T间期离散度

指标类型:

次要指标 

Outcome:

QT dispersion

Type:

Secondary indicator 

指标中文名:

西雅图心绞痛量表

指标类型:

次要指标 

Outcome:

Seattle Angina Questionnaire

Type:

Secondary indicator 

指标中文名:

McGill疼痛问卷

指标类型:

次要指标 

Outcome:

Short-Form of McGill Pain Questionnaire

Type:

Secondary indicator 

指标中文名:

焦虑自评量表

指标类型:

次要指标 

Outcome:

self-rating anxiety scale

Type:

Secondary indicator 

指标中文名:

抑郁抑郁量表

指标类型:

次要指标 

Outcome:

self-rating depression scale

Type:

Secondary indicator 

指标中文名:

针灸期待值

指标类型:

次要指标 

Outcome:

expectation values of acupuncture treatment

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

none

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 45 years
最大 Max age 70 years

随机方法(请说明由何人用什么方法产生随机序列):

采用中央随机系统进行动态区组随机化分组。随机化将由临床信息管理系统(北京生物信息科技有限公司)进行。针灸师接受培训,通过短信,在线网站或电话申请申请随机化。当随机化信息(包括参与者的姓名,性别和出生日期)被发送到随机化中心时,随机数和组分配将立即传递给针灸师。

性别:

男女均可

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

Randomization will be performed by a clinical information management system (Beijing Bioknow Information Science & Technology Co. Ltd., China). When randomization information are send to the randomization center, the random numbers and group assignment will be delivered to the acupuncturists immediately

Gender:

Both

盲法:

采用盲法评价,由不知分组情况的第三者进行疗效评价;资料总结阶段采用盲法统计分析,实行研究者、操作者、统计者三分离

Blinding:

Blind method for evaluators and statisticians

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

通过发表期刊文章公开原始数据

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

by publication

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

CRF表采集数据,数据电子存档管理

The repository and management of the data(Please specify what repository will be used for management of the metadata):

collect data by CRF, and manage data via computer

创建人:

Creater Name:

 2019-11-03
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