“心胆论治”针灸抗颈动脉粥样硬化斑块的临床研究

注册号:

Registration number:

AMCTR-IOR-18000218 

注册号获得时间:

Date of releasing the registration number:

2018/11/7 10:58:33 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

“心胆论治”针灸抗颈动脉粥样硬化斑块的临床研究 

Public title:

Clinical effect of acupuncture and moxibustion in the treatment of atherothrombosis 

研究课题的正式科学名称:

“心胆论治”针灸抗颈动脉粥样硬化斑块的临床研究 

Scientific title:

Clinical effect of acupuncture and moxibustion in the treatment of atherothrombosis 

研究课题代号(代码):

Study subject ID:

A1-AFD018161Z0206 

在其它机构的注册号:

Secondary ID:

ChiCTR1800019259 

申请注册联系人:

周俊合 

研究负责人:

符文彬 

Applicant:

Zhou Jun-he 

Study leader:

Fu Wen-bin 

申请注册联系人电话:

Applicant telephone:

+86 13430293212 

研究负责人电话:

Study leader's telephone:

+86 13808888626 

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:

7353454@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

fuwenbin@139.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:

广东省广州市白云区机场路12号广州中医药大学 

研究负责人通讯地址:

广东省广州市越秀区大德路111号广东省中医院 

Applicant address:

12 JiChang Road, BaiYun District, GuangZhou,GuangDong, China 

Study leader's address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, 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:

广州中医药大学 

Applicant's institution:

Guangzhou University of 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:

YF2018-107-01 

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:

广东省中医院伦理委员会 

Name of the ethic committee:

Guangdong Province Hospital of TCM ethics committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-07-05 

研究实施负责(组长)单位:

广州中医药大学第二附属医院 

Primary sponsor:

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine 

研究实施负责(组长)单位地址:

广东省广州市越秀区大德路111号 

Primary sponsor's address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, 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):

广东

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

广州中医药大学第二附属医院

具体地址:

广东省广州市越秀区大德路111号

Institution
hospital:

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China

经费或物资来源:

广州中医药大学高水平大学建设(A1-AFD018161Z0206) 

Source(s) of funding:

Guangzhou University of Chinese Medicine High Level University Construction (A1-AFD018161Z0206) 

研究疾病:

动脉粥样硬化斑块形成 

Target disease:

atherothrombosis 

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:

通过针灸组、安慰组、药物组,客观评价“心胆论治”针灸方案抗颈动脉粥样硬化斑块的有效性及安全性,为临床治疗颈动脉粥样硬化斑块提供一个有效方案,进一步拓展“心胆论治”针灸治疗方案的应用。 

Objectives of Study:

Objectively evaluate the effectiveness and safety of the acupuncture and moxibustion against carotid atherosclerotic plaque through acupuncture group, placebo group and drug group, and provide an effective program for clinical treatment of carotid atherosclerotic plaque. Expand the application of acupuncture treatment plan for "heart and mind treatment". 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

(1)符合颈动脉粥样硬化斑块诊断且无心脑血管事件史; (2)颈动脉增厚,无活动性斑块,且斑块小于5个; (3)胆固醇在2.59mmol/L——8.0mmol/L,甘油三脂在1.7mmol/L——10.0mmol/L (4)年龄在25-70岁之间; (5)近2周未使用治疗动脉粥样硬化的中西药物; (6)自愿参加临床研究并同意签署知情同意书者。 

Inclusion criteria

1. Comply with the diagnosis of carotid atherosclerotic plaque and no history of cardiovascular events; 2. Carotid artery thickening, no active plaque, and plaque less than 5; 3. cholesterol 2.59 mmol/L8.0 mmol/L,Triglyceride 1.7 mmol/L10.0 mmol/L; 4. aged 25-70 years; 5. Medicine for treating atherosclerosis has not been used for nearly 2 weeks; 6. Voluntary participation in clinical studies and consent to the signing of informed consent. 

排除标准:

(1)不符合病例纳入标准者; (2)颈动脉狭窄>50% 者; (3)颈动脉斑块5个和5个以上; (4)高脂血症患者胆固醇大于8.00mmol/L,甘油三脂大于10.0mmol/LBMI≥30者; (5)曾患心肌梗塞、脑血管意外、TIA、严重创伤或行重大手术者; (6)免疫系统疾病、甲状腺功能异常、严重心肺功能不全、严重心律失常、心绞痛、心房纤颤者; (7)肝肾功能不全者;精神障碍者;酒精、药物滥用史;过敏体质; (8)年龄大于60岁、高血压、吸烟、糖尿病、肥胖、低HDL-C这六个危险因素合并4个以上。 

Exclusion criteria:

1. Those who do not meet the criteria for inclusion in the criteria; 2. Carotid stenosis >50%; 3. 5 and more carotid plaques; 4. Hyperlipidemia patients with cholesterol greater than 8.00mmol/L. Triglyceride is greater than 10.0mmol/L. BMI≥30; 5. Have suffered from myocardial infarction, cerebrovascular accident, TIA, severe trauma or major surgery; 6. Immune system diseases, thyroid dysfunction, severe cardiopulmonary insufficiency, severe arrhythmia, angina pectoris, atrial fibrillation; 7. Liver and kidney dysfunction; mentally disabled; alcohol, drug abuse history; allergies; 8. Six risk factors including 60 years old or older, hypertension, smoking, diabetes, obesity, and low HDL-C combined with more than 4. 

研究实施时间:

Study execute time:

From2018-11-05To 2019-12-31 

干预措施:

Interventions:

组别:

针灸组

样本量:

35

Group:

acupuncture group

Sample size:

干预措施:

针灸

干预措施代码:

Intervention:

acupuncture and moxibustion

Intervention code:

组别:

药物组

样本量:

35

Group:

medicine group

Sample size:

干预措施:

阿司匹林、立普妥

干预措施代码:

Intervention:

Aspirin, Lipitor

Intervention code:

组别:

安慰组

样本量:

35

Group:

placebo group.

Sample size:

干预措施:

安慰针灸

干预措施代码:

Intervention:

placebo acupuncture and moxibustion

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广东省中医院 

单位级别:

三级甲等医院 

Institution
hospital:

Guangdong province hospital of TCM  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

颈动脉彩超

指标类型:

主要指标 

Outcome:

Carotid Artery Color Doppler Ultrasound

Type:

Primary indicator 

指标中文名:

血脂

指标类型:

主要指标 

Outcome:

serum lipid metabolism

Type:

Primary indicator 

指标中文名:

血小板聚集率

指标类型:

次要指标 

Outcome:

platelet aggregation rate

Type:

Secondary indicator 

指标中文名:

凝血纤维蛋白原

指标类型:

次要指标 

Outcome:

Coagulation fibrinogen

Type:

Secondary indicator 

指标中文名:

血常规

指标类型:

次要指标 

Outcome:

complete blood count

Type:

Secondary indicator 

指标中文名:

载脂蛋白A-4

指标类型:

主要指标 

Outcome:

apolipoprotein A-IV

Type:

Primary indicator 

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

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 25 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):

由周俊合通过SPSS20.0生成随机序列号进行随机分组

性别:

男女均可

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

Random number is generated by Zhou Jun-he in SPSS20.0

Gender:

Both

盲法:

Blinding:

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):

研究结束后,为保障病人隐私,原始数据将在研究中心封存

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

After the study, in order to protect patient privacy, the initial data will be stored in the research center

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):

原始数据将密封保存,制作电子数据,保存在2台不同电脑,并制作光盘保存

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

Initial data will be sealed to preserve, and we will make the electronic data. The electronic data shoulded be stored in 2 different computers, and make a CD disk to save data

创建人:

Creater Name:

 2018-11-03
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