今天是:2019-06-17 星期一

穴位埋线与盐酸安非他酮缓释片治疗烟草依赖的对照研究
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注册号:

Registration number:

ChiCTR1900020676 

最近更新日期:

Date of Last Refreshed on:

2019-01-12 

注册时间:

Date of Registration:

2019-01-12 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

穴位埋线与盐酸安非他酮缓释片治疗烟草依赖的对照研究 

Public title:

Study for Acupoint Catgut Embedding Compared with Sustained-release Bupropion for Treating Tobacco Dependence 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

穴位埋线与盐酸安非他酮缓释片治疗烟草依赖的对照研究 

Scientific title:

Study for Acupoint Catgut Embedding Compared with Sustained-release Bupropion for Treating Tobacco Dependence 

研究课题代号(代码):

Study subject ID:

GZLC16-56 

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:

黎宏颖 

研究负责人:

何玮 

Applicant:

Li Hongying 

Study leader:

He Wei 

申请注册联系人电话:

Applicant telephone:

+86 13977125331 

研究负责人电话:

Study leader's telephone:

+86 13977125331 

申请注册联系人传真 :

Applicant Fax:

+86 0771-2621753 

研究负责人传真:

Study leader's fax:

+86 0771-2621753 

申请注册联系人电子邮件:

Applicant E-mail:

douglas800331@gmail.com 

研究负责人电子邮件:

Study leader's E-mail:

douglas800331@gmail.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:

广西南宁市共和路209号 

研究负责人通讯地址:

广西南宁市共和路209号 

Applicant address:

209 Gonghe Road, Nanning, Guangxi Zhuang Autonomous Region, China 

Study leader's address:

209 Gonghe Road, Nanning, Guangxi Zhuang Autonomous Region, China 

申请注册联系人邮政编码:

Applicant postcode:

530012 

研究负责人邮政编码:

Study leader's postcode:

530012 

申请人所在单位:

南宁市第七人民医院 

Applicant's institution:

Seventh people's Hospital of Nanning 

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:

20160817 

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:

南宁市第七人民医院伦理委员会 

Name of the ethic committee:

Ethics committee of Seventh people's Hospital of Nanning 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-08-17 

伦理委员会联系人:

王瀚 

Contact Name of the ethic committee:

Wanghan 

伦理委员会联系地址:

广西南宁市共和路209号 

Contact Address of the ethic committee:

209 Gonghe Road, Nanning, Guangxi Zhuang Autonomous Region, China 

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:

南宁市第七人民医院 

Primary sponsor:

Seventh People's Hospital of Nanning 

研究实施负责(组长)单位地址:

广西南宁市共和路209号 

Primary sponsor's address:

209 Gonghe Road, Nanning, Guangxi Zhuang Autonomous Region, 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):

广西壮族自治区

市(区县):

南宁市

Country:

China

Province:

Guangxi Zhuang Autonomous Region

City:

Nanning

单位(医院):

南宁市第七人民医院

具体地址:

广西南宁市共和路209号

Institution
hospital:

Seventh people's Hospital of Nanning

Address:

209 Gonghe Road, Nanning

经费或物资来源:

广西中医药管理局 

Source(s) of funding:

The Guangxi Zhuang Autonomous Region administration of traditional Chinese Medicine  

研究疾病:

烟草依赖 

Target disease:

Tobacco dependence 

研究疾病代码:

ICD-10 F17.2 

Target disease code:

ICD-10 F17.2 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

比较穴位埋线与盐酸安非他酮缓释片在治疗烟草依赖的临床疗效。 

Objectives of Study:

To compare the therapeutic effect of acupoint catgut embedding and sustained-release bupropion for treating tobacco dependence. 

药物成份或治疗方案详述:

将符合纳入标准的戒烟人群100例,随机分为穴位埋线组(50例)和药物组(50例)。穴位埋线组分别在心俞、神门、甜美穴(桡骨茎突上方2横指)、太冲埋线,2周治疗一次,治疗4次;对照组口服盐酸安非他酮缓释片, 150mg/日,治疗8周。通过对两组患者治疗前后的法氏烟草依赖评估量表(FTND)评分、第4周及第8周点戒烟率和连续戒烟率及疗效、治疗依从率、不良反应率进行比较。自我报告戒烟者均验证呼出气一氧化碳值小于6.5ppm。 

Description for medicine or protocol of treatment in detail:

The 100 case of tobacco dependence were randomly divided into an acupoint catgut embedding group (50 cases) and a medication group (50 cases). Acupoint catgut embedding group was applied with catgut embedding at Xinshu (BL15),Shenmen(HT7), Tim-mee (two horizontal fingers above styloid process of radius), Taichong(LR3), once two weeks, and four times in total. Medication group was treated with oral administration Sustained-release bupropion for eight weeks in total. Compare the two groups scores of Fagerstrom Test for Nicotine Dependence (FTND) before and after treatment, the point prevalence abstinence rates at 4th week and 8th week, the continuous abstinence rates, the therapeutic effects, treatment adherence rate and adverse reaction rate. Self-reported abstinence was confirmed by a carbon monoxide concentration in expired air of 6.5 ppm or less.  

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)烟龄超过1年 (2)每日吸烟量≥10支; (3)年龄为18~70岁; (4)法氏烟草依赖评估量表(FTND)评分≥4分; (5)明尼苏达烟草戒断症状量表(MNWS)评分≥1分; (6)患者愿意接受戒烟治疗,患者均签署知情同意书。 

Inclusion criteria

(1) Smoking for more than one year; (2) Smoking≥ 10 cigarettes per day; (3) Aged 18-70 years; (4) Fagerstrom Test for Nicotine Dependence score ≥ 4; (5) Minnesota Tobacco Withdrawal Symptoms Scale (MNWS) score ≥1; (6) Patients are willing to accept smoking cessation treatment, and all patients sign the informed consent form. 

排除标准:

(1)自行服用其他相关药物从而影响疗效判定者; (2)不能坚持治疗自行退出者; (3)合并其他系统严重原发疾病者; 严重肝肾功能异常; (4)有严重过敏史者或存在使用盐酸安非他酮缓释片禁忌症者。 

Exclusion criteria:

(1) Take other related drugs by oneself to affect the judgement of curative effect; (2) cannot insist on the treatment of self-withdrawal; (3) merge with other serious primary diseases; with severe liver and kidney dysfunction; (4) have a history of severe allergy or contraindication of using amphetazone hydrochloride sustained-release tablets. 

研究实施时间:

Study execute time:

From2016-01-01To 2019-01-31 

干预措施:

Interventions:

组别:

1

样本量:

50

Group:

One

Sample size:

干预措施:

穴位埋线

干预措施代码:

Intervention:

Acupoint Catgut Embedding

Intervention code:

组别:

2

样本量:

50

Group:

Two

Sample size:

干预措施:

盐酸安非他酮缓释片

干预措施代码:

Intervention:

Sustained-release bupropion

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广西壮族自治区 

市(区县):

南宁市 

Country:

China 

Province:

Guangxi Zhuang Autonomous Region 

City:

Nanning 

单位(医院):

南宁市第七人民医院 

单位级别:

二级甲等 

Institution
hospital:

Seventh people's Hospital of Nanning  

Level of the institution:

Second A Hospital 

测量指标:

Outcomes:

指标中文名:

法氏烟草依赖评估量表(FTND)评分

指标类型:

主要指标 

Outcome:

Fagerstrom Test for Nicotine Dependence (FTND)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第4周点戒烟率

指标类型:

附加指标 

Outcome:

the point prevalence abstinence rates at 4th week

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第8周点戒烟率

指标类型:

附加指标 

Outcome:

the point prevalence abstinence rates at 8th week

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

连续戒烟率

指标类型:

主要指标 

Outcome:

the continuous abstinence rates

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疗效

指标类型:

主要指标 

Outcome:

The therapeutic effects

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗依从率

指标类型:

主要指标 

Outcome:

Treatment adherence 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:

不良反应率

指标类型:

主要指标 

Outcome:

Adverse reaction 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:

明尼苏达烟草戒断症状量表

指标类型:

主要指标 

Outcome:

Minnesota Nicotine Withdrawal Scale

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:

呼出气一氧化碳含量

组织:

Sample Name:

Exhaled carbon monoxide

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:

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):

随机对照试验

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

RCT

盲法:

未说明

Blinding:

Not stated

原始数据公开时间:

The time of sharing IPD:

即时公开/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):

通过《中国针灸》上以论文公开发表方式公布

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

Published by the Chinese Acupuncture & Moxibustion

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:

使用CRF进行数据的采集和管理

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

Data collection and management using CRF

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-01-12
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