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Acupuncture to quit smoking- the detailed rules for the implementation of clinical comparative and standardization study
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注册号:

Registration number:

ChiCTR-TRC-13003544 

最近更新日期:

Date of Last Refreshed on:

2016-03-03 

注册时间:

Date of Registration:

2013-09-02 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

“针灸戒烟研究”---临床方案的规范化和比较研究 

Public title:

Acupuncture to quit smoking- the detailed rules for the implementation of clinical comparative and standardization study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

“针灸戒烟研究”---临床方案的规范化和比较研究 

Scientific title:

Acupuncture to quit smoking- the detailed rules for the implementation of clinical comparative and standardization study 

研究课题代号(代码):

Study subject ID:

201307014 

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:

王莹莹 

研究负责人:

杨金生 

Applicant:

WANG Ying-ying 

Study leader:

YANG Jin-sheng 

申请注册联系人电话:

Applicant telephone:

+86 13426485985 

研究负责人电话:

Study leader's telephone:

+86 13051271199 

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:

yyw261206@126.com 

研究负责人电子邮件:

Study leader's E-mail:

zml@ibucm.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:

北京东直门内南小街16号 

研究负责人通讯地址:

北京东直门内南小街16号 

Applicant address:

16 Nanxiaojie Street, Dongzhimennei, Dongcheng District, Beijing 

Study leader's address:

16 Nanxiaojie Street, Dongzhimennei, Dongcheng District, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

100700 

研究负责人邮政编码:

Study leader's postcode:

100700 

申请人所在单位:

中国中医科学院针灸研究所 

Applicant's institution:

Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences 

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-2013014 

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:

China Ethnics Committee of Registering Clinical Trials 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-07-22 

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:

中国中医科学院针灸研究所 

Primary sponsor:

Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences 

研究实施负责(组长)单位地址:

北京东直门内南小街16号 

Primary sponsor's address:

16 Nanxiaojie Street, Dongzhimennei, Dongcheng 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):

Country:

China

Province:

Beijing

City:

单位(医院):

国家中医药管理局

具体地址:

北京东城工体西路1号

Institution
hospital:

State Administration of Traditional Chinese Medicine of the People's Republic of China

Address:

1 West Gongti Road, Dongcheng District, Beijing

经费或物资来源:

中国财政部 

Source(s) of funding:

Ministry of Finance of China 

研究疾病:

烟草依赖 

Target disease:

Tobacco dependence 

研究疾病代码:

F17.2 

Target disease code:

F17.2 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

在以往大样本针灸戒烟疗效观察的基础上,开展针灸戒烟方案的多中心、随机对照研究,验证针刺、耳穴以及针灸治疗仪对尼古丁依赖者戒断症状确切疗效,并从卫生经济学评价针灸戒烟的效益性,制定可推广的、实用性强的医者干预和戒烟者自我操作的针灸戒烟方案。 

Objectives of Study:

To carry out acupuncture cessation programs on the basis of previous large sample acupuncture to quit smoking, of multi-center, randomized controlled study to verify the exact effect in eliminating withdrawal symptoms of nicotine dependence by the means of acupuncture, ear acupuncture and treatment by instrument. We will also evaluate the financial benefits of this program and to make a more practical medical intervention and self-operating acupuncture cessation programs. 

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:

①自愿戒烟者。 ②年龄18岁~70岁。 ③烟龄≧1年。 ④吸烟量≧10支/天。 ⑤尿可的宁检测呈阳性。 ⑥知情同意,签署知情同意书,并自愿受试。 ⑦如果已经接受过其他戒烟治疗,经过5天以上的洗脱期。 

Inclusion criteria

(1) Voluntary quitters; (2) Aged 18 years to 70 years; (3) Smoking year >=1 year; (4) Amount of smoking >=10 cigarettes a day; (5) Urinary nicotine tested positive; (6) Informed consent signed; (7) If you have already received other smoking cessation treatment, after a washout period of more than five days. 

排除标准:

①患严重的心、肺、脑、血液系统疾病以及糖尿病患者。 ②患有精神疾患和吸毒者。 ③患有诊断不明确的疾病者。 ④有出凝血机制障碍或正服用抗凝血药物的人士。 ⑤孕妇。 

Exclusion criteria:

(1) Suffering from severe heart, lung, brain, blood diseases, and diabetes; (2) Suffering from mental illness or drug users; (3) Suffering from those undiagnosed diseases; (4) Coagulation disorders or those who are taking anti-clotting drug; (5) Pregnant women. 

研究实施时间:

Study execute time:

From2013-03-01To 2015-03-03 

征募观察对象时间:

Recruiting time:

From2013-09-01To 2015-09-02 

干预措施:

Interventions:

组别:

针刺组

样本量:

100

Group:

Acupuncture group

Sample size:

干预措施:

体针疗法

干预措施代码:

Intervention:

Acupuncture therapy

Intervention code:

组别:

耳穴组

样本量:

100

Group:

Auricular group

Sample size:

干预措施:

耳穴按压

干预措施代码:

Intervention:

Auricular acupressure

Intervention code:

组别:

针刺+耳穴组

样本量:

100

Group:

Acupuncture and auricular group

Sample size:

干预措施:

耳穴按压

干预措施代码:

Intervention:

auricular acupressure method

Intervention code:

组别:

经皮电神经刺激

样本量:

100

Group:

Transcutaneous electrical stimulation device group

Sample size:

干预措施:

经皮电神经刺激

干预措施代码:

Intervention:

Acupuncture treatment instrument TENS electrodes

Intervention code:

组别:

尼古丁替代疗法组

样本量:

100

Group:

Nicotine replacement therapy group

Sample size:

干预措施:

尼古丁贴片疗法

干预措施代码:

Intervention:

Nicotine gum replacement therapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

东城区 

Country:

China 

Province:

Beijing 

City:

Dongcheng District 

单位(医院):

中国中医科学院针灸医院 

单位级别:

一级 

Institution
hospital:

Hospital of Acupuncture and Moxibustion CACMS  

Level of the institution:

Grade 1 

国家:

中国 

省(直辖市):

北京 

市(区县):

东城区 

Country:

China 

Province:

Beijing 

City:

Chaoyang District 

单位(医院):

北京朝阳医院 

单位级别:

三级 

Institution
hospital:

BEIJING CHAO-YANG HOSPITA  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

北京 

市(区县):

海淀区 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京市海淀医院 

单位级别:

三级 

Institution
hospital:

Beijing Haidian Hospital  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

江苏 

市(区县):

海定区 

Country:

China 

Province:

Jiangsu 

City:

Jintan City 

单位(医院):

金坛市中医医院 

单位级别:

二级 

Institution
hospital:

Jintan Hospital Of Traditional Chinese Medicine  

Level of the institution:

Secondary 

测量指标:

Outcomes:

指标中文名:

半年戒断率

指标类型:

主要指标 

Outcome:

the 6 months continuous abstinence rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼出气CO含量

指标类型:

主要指标 

Outcome:

exhaled CO levels

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿可替宁含量

指标类型:

主要指标 

Outcome:

Urine Cotinin

Type:

Primary indicator 

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:

标本中文名:

呼出气

组织:

口腔

Sample Name:

Exhaled air

Tissue:

mouth

人体标本去向

其它 

说明

排出到空气

Fate of sample:

Others 

Note:

Discharge into the air

标本中文名:

尿液

组织:

肾脏

Sample Name:

Urine

Tissue:

Kidney

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 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):

中央随机,由中国科学院临床基础理论研究所评价中心托管

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

The Central Randomization System is under the trusteeship of the Clinical Evaluation Center of China

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

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):

中国中医科学院中医临床基础医学研究所评价中心

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

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:

中国中医科学院中医临床基础医学研究所评价中心

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

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2013-09-02
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