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Traditional Chinese Medicine as concomitant treatment for overweight and obesity
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注册号：

Registration number：

 ChiCTR2000040208 

最近更新日期：

Date of Last Refreshed on：

 2020-11-25 05:21:37 

注册时间：

Date of Registration：

 2020-11-25 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Traditional Chinese Medicine as concomitant treatment for overweight and obesity

Public title：

Traditional Chinese Medicine as concomitant treatment for overweight and obesity

注册题目简写：

English Acronym：

研究课题的正式科学名称：

BARiatric Basic Questionairy for Traditional Chinese Medicine

Scientific title：

BARiatric Basic Questionairy for Traditional Chinese Medicine

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：

ChiMCTR2000004081

申请注册联系人：

PD Dr. med. Ulf Kessler 

研究负责人：

Prof. Dr. Peter Panhofer 

Applicant：

PD Dr. med. Ulf Kessler 

Study leader：

Prof. Dr. Peter Panhofer 

申请注册联系人电话：

Applicant telephone：

 +41 21 310 52 11

研究负责人电话：

Study leader's
telephone：

+43 1 402 26 05

申请注册联系人传真 ：

Applicant Fax：

 +41 21 310 52 13

研究负责人传真：

Study leader's fax：

 +43 1 402 26 05-89

申请注册联系人电子邮件：

Applicant E-mail：

 ulf-kessler@hotmail.com

研究负责人电子邮件：

Study leader's E-mail：

 peter.panhofer@med.sfu.ac.at

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)：

 www.drpanhofer.com

申请注册联系人通讯地址：

Chemin des Croix-Rouges 7

研究负责人通讯地址：

MedOstWest Zentrum Leo-Slezak-Gasse 14/4 A - 1180 Wien

Applicant address：

Chemin des Croix-Rouges 7

Study leader's address：

MedOstWest Zentrum Leo-Slezak-Gasse 14/4 A - 1180 Wien

申请注册联系人邮政编码：

Applicant postcode：

 1007

研究负责人邮政编码：

Study leader's postcode：

 1180

申请人所在单位：

瑞士Department of Pediatric Surgery, University Hospital Bern, University of Bern

Applicant's institution：

Department of Pediatric Surgery, University Hospital Bern, University of Bern, Switzerland

研究负责人所在单位：

奥地利维也纳Complementary Medicine, Sigmund Freud University Vienna

Affiliation of the Leader：

Complementary Medicine, Sigmund Freud University Vienna

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：

 E17-N01-02

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：

Ethikkomission Krankenhaus G?ttlicher Heiland, Vienna, Austria

Name of the ethic committee：

Ethikkomission Krankenhaus G?ttlicher Heiland, Vienna, Austria

伦理委员会批准日期：

Date of approved by ethic committee：

 2018-01-10 00:00:00

伦理委员会联系人：

Dr. Michael Peintinger

Contact Name of the ethic committee：

Dr. Michael Peintinger

伦理委员会联系地址：

Krankenhaus G?ttlicher Heiland, Vienna, Austria

Contact Address of the ethic committee：

Krankenhaus G?ttlicher Heiland, Vienna, Austria

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +43 1 400 88 -9113

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 michael.peintinger@khgh.at

研究实施负责（组长）单位：

Univ. Prof. Dr. Michael Krebs

Primary sponsor：

Univ. Prof. Dr. Michael Krebs

研究实施负责（组长）单位地址：

Universitätsklinik für Innere Medizin III, Abteilung für Endokrinologie und Stoffwechsel, Medizinische Universität Wien / AKH - Währinger Gürtel 18-20, A-1090 Vienna, Austria

Primary sponsor's address：

Universitätsklinik für Innere Medizin III, Abteilung für Endokrinologie und Stoffwechsel, Medizinische Universität Wien / AKH - Währinger Gürtel 18-20, A-1090 Vienna, Austria

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

奥地利

省(直辖市)：

维也纳

市(区县)：

维也纳

Country：

Austria

Province：

Vienna

City：

Vienna

单位(医院)：

Sigmund Freud University

具体地址：

MedOstWest Zentrum, Leo-Slezak-Gasse 14/4, 1180 Vienna, Austria

Institution
hospital：

Sigmund Freud University

Address：

MedOstWest Zentrum, Leo-Slezak-Gasse 14/4, 1180 Vienna, Austria

经费或物资来源：

Internal financement, no external resources

Source(s) of funding：

Internal financement, no external resources

研究疾病：

Weight regain after bariatric surgery  

Target disease：

Weight regain after bariatric surgery

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

析因分组（即根据危险因素或暴露因素分组） 

Study design：

Factorial 

研究目的：

We hypothezised that patients with a secondary increase in weight may be more interested in TCM therapy than patients who retain a stable weight. We therefore compared experiences with CAM and the desire for a complementary TCM treatment between patients with stable weight (SW) and patients who experienced weight regain (WR) during postoperative follow-up period.  

Objectives of Study：

We hypothezised that patients with a secondary increase in weight may be more interested in TCM therapy than patients who retain a stable weight. We therefore compared experiences with CAM and the desire for a complementary TCM treatment between patients with stable weight (SW) and patients who experienced weight regain (WR) during postoperative follow-up period.

药物成份或治疗方案详述：

This is a retrospective single-center sub-analysis of the prospectively-collected multi-center BARBQTCM survey (BARiatric Basic Questionnairy for Traditional Chinese Medicine). The anonymous BARBQTCM questionnairy is a self-rated 7-item disease-specific inventory focussing on overweight, obesity and PSALMS. It includes demographic parameters, former treatments for obesity, prior experience with CAM, request for TCM therapies, disease-specific complaints that patients would treat with TCM, frequency with which patients would visit a TCM outpatient clinic per month, and the amount of money patients would be willing to spend per month for TCM therapies. 

Description for medicine or protocol of treatment in detail：

This is a retrospective single-center sub-analysis of the prospectively-collected multi-center BARBQTCM survey (BARiatric Basic Questionnairy for Traditional Chinese Medicine). The anonymous BARBQTCM questionnairy is a self-rated 7-item disease-specific inventory focussing on overweight, obesity and PSALMS. It includes demographic parameters, former treatments for obesity, prior experience with CAM, request for TCM therapies, disease-specific complaints that patients would treat with TCM, frequency with which patients would visit a TCM outpatient clinic per month, and the amount of money patients would be willing to spend per month for TCM therapies. 

纳入标准：

Inclusion criteria

排除标准：

Exclusion criteria were patients who did not have bariatric surgery, missing information about surgical intervention, and missing information about post-operative weight course.

Exclusion criteria：

Exclusion criteria were patients who did not have bariatric surgery, missing information about surgical intervention, and missing information about post-operative weight course.

研究实施时间：

Study execute time：

从 From 2016-06-01 00:00:00至 To 2020-11-16 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2017-06-01 00:00:00 至 To 2018-12-31 00:00:00

干预措施：

Interventions：

组别：

weight regain

样本量：

 150

Group：

weight regain

Sample size：

干预措施：

questionnaire

干预措施代码：

Intervention：

questionnaire

Intervention code：

组别：

no weight regain

样本量：

 317

Group：

no weight regain

Sample size：

干预措施：

questionnaire

干预措施代码：

Intervention：

questionnaire

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 瑞士

省(直辖市)：

 伯尔尼 

市(区县)：

  

Country：

Switzerland

Province：

Bern

City：

Bern

单位(医院)：

 Zentrum für bariatrische Chirurgie 

单位级别：

 Outpatient bariatric center 

Institution
hospital：

Zentrum für bariatrische Chirurgie

Level of the institution：

Outpatient bariatric center

测量指标：

Outcomes：

指标中文名：

Desire for complementary TCM

指标类型：

主要指标

Outcome：

Desire for complementary TCM

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：

组织：

Sample Name：

BARBQTCM: BARiatric Basic Questionairy for Traditional Chinese Medicine

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 岁 years
最大 Max age 99 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）：

No

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

no randomization

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

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

否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）：

data is anonymized, no data sharing

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

data is anonymized, no data sharing

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：

(BARiatric Basic Questionnairy for Traditional Chinese Medicine). The anonymous BARBQTCM questionnairy is a self-rated 7-item disease-specific inventory focussing on overweight, obesity and PSALMS. It includes demographic parameters, former treatments for obesity, prior experience with CAM, request for TCM therapies, disease-specific complaints that patients would treat with TCM, frequency with which patients would visit a TCM outpatient clinic per month, and the amount of money patients would be willing to spend per month for TCM therapies.

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

This is a retrospective single-center sub-analysis of the prospectively-collected multi-center BARBQTCM survey (BARiatric Basic Questionnairy for Traditional Chinese Medicine). The anonymous BARBQTCM questionnairy is a self-rated 7-item disease-specific inventory focussing on overweight, obesity and PSALMS. It includes demographic parameters, former treatments for obesity, prior experience with CAM, request for TCM therapies, disease-specific complaints that patients would treat with TCM, frequency with which patients would visit a TCM outpatient clinic per month, and the amount of money patients would be willing to spend per month for TCM therapies.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-11-25 05:21:22
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