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An fcMRI Cerebral Functional Imaging Study on Needling in Taichong (LR3) Combining with Taixi (KI3) of hypertension patients
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注册号:

Registration number:

ChiCTR-TRC-12002427 

最近更新日期:

Date of Last Refreshed on:

2015-09-04 

注册时间:

Date of Registration:

2012-04-08 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

针刺太冲配伍太溪穴治疗高血压患者fcMRI脑功能成像研究 

Public title:

An fcMRI Cerebral Functional Imaging Study on Needling in Taichong (LR3) Combining with Taixi (KI3) of hypertension patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

针刺太冲配伍太溪穴治疗高血压患者fcMRI脑功能成像研究 

Scientific title:

An fcMRI Cerebral Functional Imaging Study on Needling in Taichong (LR3) Combining with Taixi (KI3) of hypertension patients 

研究课题代号(代码):

Study subject ID:

2012CB518504 

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:

黄泳 

研究负责人:

黄泳 

Applicant:

Huang Yong 

Study leader:

Huang Yong 

申请注册联系人电话:

Applicant telephone:

+86 13719189644 

研究负责人电话:

Study leader's telephone:

+86 13719189644 

申请注册联系人传真 :

Applicant Fax:

+86 020 61648245 

研究负责人传真:

Study leader's fax:

+86 020 61648245 

申请注册联系人电子邮件:

Applicant E-mail:

nfhy@fimmu.com 

研究负责人电子邮件:

Study leader's E-mail:

nfhy@fimmu.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

www.fimmu.com 

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:

广东省广州市沙太南路1023号南方医科大学中医药学院 

研究负责人通讯地址:

广东省广州市沙太南路1023号南方医科大学中医药学院 

Applicant address:

1023 South Shatai Road, Guangzhou, Canton, China 

Study leader's address:

1023 South Shatai Road, Guangzhou, Canton, China 

申请注册联系人邮政编码:

Applicant postcode:

510515 

研究负责人邮政编码:

Study leader's postcode:

510515 

申请人所在单位:

南方医科大学 

Applicant's institution:

Southern Medical University 

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:

ChiECRCT-2012011 

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:

中国注册临床试验伦理审查委员会 

Name of the ethic committee:

Chinese clinical trial ethical review committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2012-08-01 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

南方医科大学 

Primary sponsor:

Southern Medical University 

研究实施负责(组长)单位地址:

广东省广州市沙太南路1023号 

Primary sponsor's address:

1023 South Shatai Road, Guangzhou, Canton, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

“973计划”课题基金 

Source(s) of funding:

Research Fund of the National Basic Research Program of China (973 Program) 

研究疾病:

原发性高血压 

Target disease:

primary hypertension 

研究疾病代码:

R544.1 

Target disease code:

R544.1 

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 

研究目的:

运用fcMRI观察针刺表里经原络配穴后脑功能活动的变化,寻找与经穴循经配伍特异性相关的特异脑区,探讨表里经原络配穴对经穴效应特异性的影响特点及中枢整合机制。 本研究在生理、病理状态下,通过静息态磁共振脑功能成像分析,分别观察针刺太冲穴、太溪穴、非穴和太冲配伍太溪穴、太冲配伍对不同脑区激活效应的变化及其连接,探索针刺治疗高血压的机理,为临床治疗高血压的针刺取穴作理论支持。 

Objectives of Study:

To observe the cerebral functional modification's connections and changes with fcMRI in physical and pathologic conditions when needling Taichong(LR3), Taixi(KI3), non-acupoint, Taichong combining with Taixi, Taichong combining with non-acupoint acupoints, in order to explore the mechanisation of acupunture on the treatment of hypertension and provide theory support for acupuncture treatment of hypertension in the clinical. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

健康志愿者纳入标准: ①年龄在 21-28岁之间未接触针刺在校大学生,男女各半; ② 饮食规律,不嗜烟酒、茶、咖啡等,睡眠正常(晚上12点前休息),体型适中(BMI指数分别为20-25,19-24),无精神或神经系统疾病史; ③ 愿配合试验的进行,且签署知情同意书。 原发性高血压患者纳入标准: ① 初诊病人,男性18岁至55岁,女性18岁至65岁,右利手,男女不限; ② 符合世界卫生组织(WHO)/国际高血压联盟(ISH)2003年修改颁布的《高血压指南》诊断和危险分层标准的I-II期的中危患者;③ 中医辨证为阴虚阳亢型(辨证分型参考国家中医药管理局《中药新药临床研究指导原则(试行)》标准);④ 自愿配合试验的进行,且签署知情同意书。 

Inclusion criteria

The healthy volunteers: 1. students without acupuncture experience between the ages of 21 to 28 years old; half male and half female; 2. regular diet, no propensity with alcoholic, tobacco, coffee and tea, normal sleep(go to bed before 12 clock at night) and moderate size(BMI is between 20-25 for male and 19-24 for famale); no mental or nervous system disease history; 3. Volunteers should be informed and sign the informed consent. The primary hypertension: 1. patients at preliminary diagnosis between the ages of 18 to 55 years old for male and 18 to 65 for female, right handedness, male and female both are allowed; 2. patients in the state of I or II phase according to the diagnosis and risk stratification standard of "hypertension guide" amended and issued in 2003 of the World Health Organization (WHO)/International Hypertension League (ISH); 3. The syndrome differentiation of TCM is deficiency of Yin leading to hyper activity of Yang (Typing of syndrome differentiation refers to the standard of "Guidelines for the Clinical Research of Chinese Medicine New Drugs "(Trial) established by State Chinese Medicine Administration); 4. Volunteers should be informed and sign the informed consent. 

排除标准:

健康志愿者排除标准 ①近期内(1个月内)患各类疼痛(包括痛经)及失眠等影响治疗效果者;②体内无金属类物质如心脏支架或金属假牙等; ③ 受试穴位处有皮肤病及皮肤破损者; ④患有血小板减少、血友病、凝血功能障碍等疾病;有晕针史者;⑤试验1个月前, 针刺应答预试验无针刺反应者和针刺反应过度敏感者;试验近1个月接受过针刺治疗者;⑥对噪音、低温环境反应强烈及空间幽闭恐惧症患者。 高血压患者排除标准: ①继发性高血压病,妊娠高血压病患者;②合并其他脏器的严重疾病,及糖尿病、血友病、凝血功能障碍等非针刺适应症患者;③精神病患者,孕妇、哺乳期妇女;④受试穴位处有皮肤病及皮肤破损者;⑤在试验观察期间接受其它高血压相关治疗;⑥近期内(1个月内)患各类疼痛(包括痛经)及失眠等影响治疗效果者;⑦有晕针史者;⑧对噪音、低温环境反应强烈及空间幽闭恐惧症患者。 

Exclusion criteria:

Healthy volunteers should be excluded: 1. with all kinds of pain (including dysmenorrhea) and insomnia that may affect the treatment effect in the near future (1 month); 2. history of any metallic implant in the body,like heart stent or metal dentures; 3. dermatosis or skin damage near the acupoint where acupuncture would be applied; 4. with thrombocytopenia, hemophilia, blood coagulation dysfunction disease or the history of faintng during acupuncture treatment; 5. no response or excessive sensitive reaction in the acupuncture response pretest which is hold 1 month before the test; received other acupuncture treatment 1 month before the test; 6. Over reactive to noise, low temperature environment and history of claustrophobia. Hypertension volunteers should be excluded: 1. secondary hypertension, hypertension of pregnancy; 2. With serious disease of other organs, and other diseases like diabetes, hemophilia, coagulant function obstacle patients; 3. Mental patients, pregnancy and nursing mothers; 4. Dermatosis or skin damage near the acupoint where acupuncture would be applied; 5. Received other treatments for hypertension during the experimental observation period; 6. with all kinds of pain (including dysmenorrhea) and insomnia that may affect the treatment effect in the near future (1 month); 7. history of faintng during acupuncture treatment; 8. Over reactive to noise, low temperature environment and history of claustrophobia. 

研究实施时间:

Study execute time:

From2012-06-01To 2016-12-31 

征募观察对象时间:

Recruiting time:

From2012-06-01To 2016-06-30 

干预措施:

Interventions:

组别:

太冲高血压患者组

样本量:

12

Group:

P1

Sample size:

干预措施:

针刺太冲穴30分钟,并进行血压测量和fcMRI脑功能成像

干预措施代码:

Intervention:

All subjects reveive acupuncture at Taichong for 30 min, proceed blood pressure measurement and cerebral function imaging by fcMRI

Intervention code:

组别:

太溪高血压患者组

样本量:

12

Group:

P2

Sample size:

干预措施:

针刺太溪穴30分钟,并进行血压测量和fcMRI脑功能成像

干预措施代码:

Intervention:

All subjects reveive acupuncture at Taixi for 30 min, proceed blood pressure measurement and cerebral function imaging by fcMRI

Intervention code:

组别:

太冲穴配伍太溪穴高血压患者组

样本量:

12

Group:

P3

Sample size:

干预措施:

针刺太冲穴配伍太溪穴30分钟,并进行血压测量和fcMRI脑功能成像

干预措施代码:

Intervention:

All subjects reveive acupuncture at Taichong and Taixi acupoints for 30 min, proceed blood pressure measurement and cerebral function imaging by fcMRI

Intervention code:

组别:

非穴高血压患者组

样本量:

12

Group:

P4

Sample size:

干预措施:

针刺非穴30分钟,并进行血压测量和fcMRI脑功能成像

干预措施代码:

Intervention:

All subjects reveive acupuncture at non-acupoint for 30 min, proceed blood pressure measurement and cerebral function imaging by fcMRI

Intervention code:

组别:

太冲配伍非穴高血压患者组

样本量:

12

Group:

P5

Sample size:

干预措施:

针刺太冲配伍非穴30分钟,并进行血压测量和fcMRI脑功能成像

干预措施代码:

Intervention:

All subjects reveive acupuncture at Taichong and non-acupoint for 30 min, proceed blood pressure measurement and cerebral function imaging by fcMRI

Intervention code:

组别:

太冲正常人组

样本量:

12

Group:

N1

Sample size:

干预措施:

针刺太冲穴30分钟,并进行血压测量和fcMRI脑功能成像

干预措施代码:

Intervention:

All subjects reveive acupuncture at Taixi for 30 min, proceed blood pressure measurement and cerebral function imaging by fcMRI

Intervention code:

组别:

太溪正常组

样本量:

12

Group:

N2

Sample size:

干预措施:

针刺太溪穴30分钟,并进行血压测量和fcMRI脑功能成像

干预措施代码:

Intervention:

All subjects reveive acupuncture at Taixi for 30 min, proceed blood pressure measurement and cerebral function imaging by fcMRI

Intervention code:

组别:

太冲穴配伍太溪穴正常人组

样本量:

12

Group:

N3

Sample size:

干预措施:

针刺太冲穴配伍太溪穴30分钟,并进行血压测量和fcMRI脑功能成像

干预措施代码:

Intervention:

All subjects reveive acupuncture at Taichong and Taixi acupoints for 30 min, proceed blood pressure measurement and cerebral function imaging by fcMRI

Intervention code:

组别:

非穴正常人组

样本量:

12

Group:

N4

Sample size:

干预措施:

针刺非穴30分钟,并进行血压测量和fcMRI脑功能成像

干预措施代码:

Intervention:

All subjects reveive acupuncture at non-acupoint for 30 min, proceed blood pressure measurement and cerebral function imaging by fcMRI

Intervention code:

组别:

太冲配伍非穴正常人组

样本量:

12

Group:

N5

Sample size:

干预措施:

针刺太冲配伍非穴30分钟,并进行血压测量和fcMRI脑功能成像

干预措施代码:

Intervention:

All subjects reveive acupuncture at Taichong and non-acupoint for 30 min, proceed blood pressure measurement and cerebral function imaging by fcMRI

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

脑功能成像

指标类型:

主要指标 

Outcome:

cerebral functional activity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血压

指标类型:

主要指标 

Outcome:

blood pressure

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件

指标类型:

副作用指标 

Outcome:

adverse event

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

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 18 years
最大 Max age 65 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):

采用区组随机的方法。严格按照诊断标准、纳入标准和排除标准筛选病例,确定入组后,按照申请随机编码流程获得随机号码,直到完成总观察例数后结束试验。

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

Use randomized block method. Screen volunteers according to the diagnostic criteria, inclusion crit

盲法:

采用单盲法,即盲病人,采用单间治疗室,保证患者不清楚各自的取穴和操作方法。 数据统计有第三方完成,分析阶段采用盲法统计分析,实行研究者、操作者、统计着三分离。

Blinding:

The study uses the single blind method, concealed to volunteers. Volunteers will be treated in a single therapeutic room ,in oder to ensure that volunteers do not know the others' prescription and treatment methods.

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

南方医科大学

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

Southern Medical University

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:

南方医科大学

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

Southern Medical University

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2012-04-08
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