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Acupuncture Combined with Auricular Acupressure for Smoking Cessation
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注册号：

Registration number：

 ChiCTR2000033650 

最近更新日期：

Date of Last Refreshed on：

 2022-10-17 

注册时间：

Date of Registration：

2020-06-07 

注册号状态：

预注册  

Registration Status：

Prospective registration  

注册题目：

Acupuncture Combined with Auricular Acupressure for Smoking Cessation 

Public title：

Acupuncture Combined with Auricular Acupressure for Smoking Cessation 

注册题目简写：

 

English Acronym：

 

研究课题的正式科学名称：

Chinese Medicine Acupuncture Combined with Auricular Acupressure for Smoking Cessation (the Guangdong-Hong Kong-Macau Greater Bay Area) 

Scientific title：

Chinese Medicine Acupuncture Combined with Auricular Acupressure for Smoking Cessation (the Guangdong-Hong Kong-Macau Greater Bay Area) 

研究课题代号(代码)：

Study subject ID：

 

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：

ChiMCTR2000003379 

申请注册联系人：

HO Lai Fun 

研究负责人：

LIN Zhixiu 

Applicant：

HO Lai Fun 

Study leader：

LIN Zhixiu 

申请注册联系人电话：

Applicant telephone：

+852 24792126 

研究负责人电话：

Study leader's telephone：

+852 28733252 

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：

cmpst@pokoi.org.hk 

研究负责人电子邮件：

Study leader's E-mail：

linzx@cuhk.edu.hk 

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：

G/F, Shatin (Taiwai) Clinic, 2 Man Lai Road, Taiwai, Shatin, NT, Hong Kong SAR, China 

研究负责人通讯地址：

4L, Integrative Medical Centre, 4/F, Day Treatment Block, Prince of Wales Hospital, Hong Kong SAR, China 

Applicant address：

G/F, Shatin (Taiwai) Clinic, 2 Man Lai Road, Taiwai, Shatin, NT, Hong Kong SAR, China 

Study leader's address：

4L, Integrative Medical Centre, 4/F, Day Treatment Block, Prince of Wales Hospital, Hong Kong SAR, 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：

香港博愛醫院 

Applicant's institution：

Pok Oi Hospital 

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：

2020.116 

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：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會 

Name of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee 

伦理委员会批准日期：

Date of approved by ethic committee：

2020-04-15 

伦理委员会联系人：

Envy Lee 

Contact Name of the ethic committee：

Envy Lee 

伦理委员会联系地址：

中國香港特別行政區新界沙田銀城街威爾士親王醫院呂志和臨床醫學大樓8樓 

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong SAR, 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：

博愛醫院 

Primary sponsor：

Pok Oi Hospital 

研究实施负责（组长）单位地址：

G/F, Shatin (Taiwai) Clinic, 2 Man Lai Road, Taiwai, Shatin, NT, Hong Kong SAR, China 

Primary sponsor's address：

G/F, Shatin (Taiwai) Clinic, 2 Man Lai Road, Taiwai, Shatin, NT, Hong Kong SAR, China 

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

This study for Hong Kong sites do not receive specific funding. 

Source(s) of funding：

This study for Hong Kong sites do not receive specific funding. 

研究疾病：

吸煙 

Target disease：

Smoking 

研究疾病代码：

 

Target disease code：

 

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：

This study aim to verify the safety and efficacy of acupuncture combined with auricular acupressure on smoking cessation, and evaluate the cost-effectiveness of acupuncture-based smoking cessation; to develop a generalizable, practical, self-operable but medically intervened acupuncture-based smoking cessation regimen, complement the China Clinical Smoking Cessation Guideline with acupuncture-based smoking cessation, and provide sufficient clinical research evidence. 

Objectives of Study：

This study aim to verify the safety and efficacy of acupuncture combined with auricular acupressure on smoking cessation, and evaluate the cost-effectiveness of acupuncture-based smoking cessation; to develop a generalizable, practical, self-operable but medically intervened acupuncture-based smoking cessation regimen, complement the China Clinical Smoking Cessation Guideline with acupuncture-based smoking cessation, and provide sufficient clinical research evidence. 

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

研究设计：

单臂 

Study design：

Single arm 

纳入标准：

(1) voluntarily quit smoking; (2) aged 18-65 years Chinese; (3) have a smoking duration >= 1 year; (4) have a smoking quantity >= 20 cigarettes per day (CPD) in the past year; (5) show a positive test for salivary cotinine; (6) have a Fagerstrom test for nicotine dependence (FTND) score >= 4 (moderate and severe smokers); (7) have provided informed consent and volunteered to participate; (8) have undergone a washout period of more than one month if other smoking cessation treatments were previously conducted. 

Inclusion criteria

(1) voluntarily quit smoking; (2) aged 18-65 years Chinese; (3) have a smoking duration >= 1 year; (4) have a smoking quantity >= 20 cigarettes per day (CPD) in the past year; (5) show a positive test for salivary cotinine; (6) have a Fagerstrom test for nicotine dependence (FTND) score >= 4 (moderate and severe smokers); (7) have provided informed consent and volunteered to participate; (8) have undergone a washout period of more than one month if other smoking cessation treatments were previously conducted. 

排除标准：

(1) severe and unstable cardiac, pulmonary, cerebral, and hematologic diseases, or diabetes with other complications; (2) mental illness and drug abuse; (3) stroke or nervous system diseases; (4) unknown diseases; (5) coagulopathy or current administration of anticoagulant drugs; (6) moderate or severe liver and kidney impairment; (7) pregnant women; (8) those with a history of smoking cessation treatments such as acupuncture, auricular acupressure, or nicotine replacement therapy within the past one month. 

Exclusion criteria：

(1) severe and unstable cardiac, pulmonary, cerebral, and hematologic diseases, or diabetes with other complications; (2) mental illness and drug abuse; (3) stroke or nervous system diseases; (4) unknown diseases; (5) coagulopathy or current administration of anticoagulant drugs; (6) moderate or severe liver and kidney impairment; (7) pregnant women; (8) those with a history of smoking cessation treatments such as acupuncture, auricular acupressure, or nicotine replacement therapy within the past one month. 

研究实施时间：

Study execute time：

从From2020-09-24至To 2022-02-22 

征募观察对象时间：

Recruiting time：

从From2020-09-24至To 2021-08-02 

干预措施：

Interventions：

组别：

Case series

样本量：

 30

Group：

Case series

Sample size：

干预措施：

acupuncture combined with auricular acupressure

干预措施代码：

Intervention：

acupuncture combined with auricular acupressure

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

测量指标：

Outcomes：

指标中文名：

The success rate of smoking cessation at week 24

指标类型：

主要指标 

Outcome：

The success rate of smoking cessation at week 24

Type：

Primary indicator 

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

The success rate of complete smoking cessation

指标类型：

次要指标 

Outcome：

The success rate of complete smoking cessation

Type：

Secondary indicator 

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

The success rate of smoking cessation at other time points

指标类型：

次要指标 

Outcome：

The success rate of smoking cessation at other time points

Type：

Secondary indicator 

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Exhaled carbon monoxide level

指标类型：

次要指标 

Outcome：

Exhaled carbon monoxide level

Type：

Secondary indicator 

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Salivary cotinine level

指标类型：

次要指标 

Outcome：

Salivary cotinine level

Type：

Secondary indicator 

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Fagerstrom test for nicotine dependence (FTND) score

指标类型：

次要指标 

Outcome：

Fagerstrom test for nicotine dependence (FTND) score

Type：

Secondary indicator 

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Autonomy over smoking scale (AUTOS) score

指标类型：

次要指标 

Outcome：

Autonomy over smoking scale (AUTOS) score

Type：

Secondary indicator 

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Hamilton anxiety rating scale (HAMA) score

指标类型：

次要指标 

Outcome：

Hamilton anxiety rating scale (HAMA) score

Type：

Secondary indicator 

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Self-rating anxiety scale (SAS) score

指标类型：

次要指标 

Outcome：

Self-rating anxiety scale (SAS) score

Type：

Secondary indicator 

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Pittsburgh sleep quality index (PSQI) Score

指标类型：

次要指标 

Outcome：

Pittsburgh sleep quality index (PSQI) Score

Type：

Secondary 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：

征募研究对象情况：

Recruiting status：

结束

Completed

年龄范围：

Participant age：

最小 Min age 18 岁 years
最大 Max age 65 岁 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）：

N/A

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

N/A

盲法：

N/A

Blinding：

N/A

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

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）：

The datasets used are available from the researchers on reasonable request.

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

The datasets used are available from the researchers on reasonable request.

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：

CRF

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

CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

 2020-06-07
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