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Study on the effect of acupoint embedding on simple obesity based on the detection of subcutaneous fat thickness

Registration number：

ITMCTR2100004741

Date of Last Refreshed on：

2021-04-17

Date of Registration：

2021-04-17

Registration Status：

Prospective registration

Public title：

Study on the effect of acupoint embedding on simple obesity based on the detection of subcutaneous fat thickness

English Acronym：

Scientific title：

Study on the effect of acupoint embedding on simple obesity based on the detection of subcutaneous fat thickness

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2100045488 ; ChiMCTR2100004741

Applicant：

Zhang Xin

Study leader：

Tan Qiwen

Applicant telephone：

+86 13953172234

Study leader's telephone：

+86 13793188118

Applicant Fax：

Study leader's fax：

Applicant E-mail：

doctorzhangxin@qq.com

Study leader's E-mail：

tan_qiwen@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

16369 Jingshi Road, Lixia District, Jinan, Shandong

Study leader's address：

16369 Jingshi Road, Lixia District, Jinan, Shandong

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Shandong University of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

（2021）伦理第（20）号-KY

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of The Attached Hospital of Shandong University of TCM

Date of approved by ethic committee：

2021/3/16 0:00:00

Contact Name of the ethic committee：

Zhang Xin

Contact Address of the ethic committee：

16369 Jingshi Road, Lixia District, Jinan, Shandong

Contact phone of the ethic committee：

+86 531 68616733

Contact email of the ethic committee：

Primary sponsor：

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Primary sponsor's address：

16369 Jingshi Road, Lixia District, Jinan, Shandong

Secondary sponsor：

Country：

China

Province：

Shangdong

City：

Ji'nan

Institution
hospital：

The Attached Hospital of Shandong University of TCM

Address：

16369 Jingshi Road, Lixia District

Source(s) of funding：

self-funded

Target disease：

Obesity

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

In this study, acupoint catgut implantation was performed on patients with simple obesity, and the clinical effects were compared and observed to provide an effective clinical basis for the clinical treatment of simple obesity.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1.Simple obesity (obesity without organic disease) who meets the above diagnostic criteria of Western medicine 2.28kg/m2<=（BMI）<32kg/m2 3.No other weight loss measures were taken within 2 months before participating in this study 4.Between 18 and 60 years old, regardless of gender 5.The subject reads and signs the informed consent form, and voluntarily joins the project

Exclusion criteria：

1.Patients with secondary obesity; 2.Those who are allergic to heterologous proteins or have scars; 3.Pregnant women and breastfeeding women; 4.Patients with diabetes, major heart, brain, liver and kidney diseases, infectious diseases, blood system diseases, mental diseases, and malignant tumors.

Study execute time：

From 2021-03-16

To      2022-03-16

Recruiting time：

From 2021-04-17

To      1990-01-01

Interventions：

36

Group：

Experimental group

Sample size：

Intervention：

Acupoint embedding

Intervention code：

36

Group：

Control group

Sample size：

Intervention：

Lifestyle intervention

Intervention code：

Total sample size ： 72

Countries of recruitment
and research settings：

Country：

China

Province：

Shandong

City：

Ji'nan

Institution/hospital：

The Attached Hospital of Shandong University of TCM

Level of the institution：

Tertiary A

Outcomes：

Outcome：

waistline

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Subcutaneous fat thickness

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

hipline

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Body fat percentage

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

weight

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

height

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

18
Min age years
60
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Random digital table method

Blinding：

Not stated

IPD sharing：

Yes

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

Shared network disk

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

Data collection and data verification management are handled by different individuals. The data collection records the CRF form and the data management is stored by the scientific research and innovation team of ZhiWeiBing of Shandong University of TCM.

Data Managemen Committee：

Not yet

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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