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Observation on the clinical effect of acupuncture and moxibustion on demeaning beauty

Registration number：

ITMCTR2024000600

Date of Last Refreshed on：

2024-10-22

Date of Registration：

2024-10-22

Registration Status：

Retrospective registration

Public title：

Observation on the clinical effect of acupuncture and moxibustion on demeaning beauty

English Acronym：

Observation on the clinical effect of acupuncture and moxibustion on demeaning beauty

Scientific title：

Observation on the clinical effect of acupuncture and moxibustion on demeaning beauty

Scientific title acronym：

Observation on the clinical effect of acupuncture and moxibustion on demeaning beauty

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Yi Luo

Study leader：

Jing Xu

Applicant telephone：

19981278386

Study leader's telephone：

13881749083

Applicant Fax：

Study leader's fax：

Applicant E-mail：

luoyi9949@163.com

Study leader's E-mail：

195940644@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

37 Shierqiao Road Jinniu District Chengdu Sichuan

Study leader's address：

37 Shierqiao Road Jinniu District Chengdu Sichuan

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Chengdu University of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2022KL-109

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Date of approved by ethic committee：

2023/1/13 0:00:00

Contact Name of the ethic committee：

ma xitao

Contact Address of the ethic committee：

Medical Ethics Committee of the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine Jinniu District Chengdu Sichuan China

Contact phone of the ethic committee：

2887783139

Contact email of the ethic committee：

ethicscd@126.com

Primary sponsor：

Chengdu University of Traditional Chinese Medicine

Primary sponsor's address：

37 Shierqiao Road Jinniu District Chengdu Sichuan

Secondary sponsor：

Country：

china

Province：

sichuan

City：

chengdu

Institution
hospital：

Chengdu University of Traditional Chinese Medicine

Address：

37 Shierqiao Road Jinniu District Chengdu Sichuan

Source(s) of funding：

National Nature Science Foundation of China

Target disease：

Facial aging

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

This study used percutaneous acupoint electrical stimulation to observe the clinical effect of facial aging treatment provide theoretical support for the study of acupuncture technology in facial rejuvenation and lay a certain foundation for the application of percutaneous acupoint electrical stimulation in facial rejuvenation.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1) Male or female subjects between the ages of 25 and 50 with different degrees of skin sagging and wrinkles on their faces; 2) Glogau Scale II and III health effects in the treatment area as assessed in the field by independent blind evaluators Try; 3) Can understand and accept the relevant knowledge and risks of percutaneous acupoint electrical stimulation and face acupuncture and sign the informed consent; 4) Can cooperate with long-term satisfaction follow-up survey; 5) In the past six months have not done any facial plastic and cosmetic treatment (such as laser RF injection surgery etc.); 6) did not take the relevant drugs (such as retinoic acid hydroquinone etc.) that affected the test results in the past six months; 7) No skin diseases or other influencing factors on the face.

Exclusion criteria：

1) Subjects who have received permanent or semi-permanent facial implants (e.g. polymethyl methacrylate silicone teflon hydroxyapatite poly-L-lactic acid etc.) anywhere on the face or who plan to have any of these implants during clinical studies; 2) Subjects whose faces received temporary dermal fillers (such as hyaluronic acid fat botox collagen etc.) within 12 months before enrollment or photoelectric treatment such as laser radiofrequency dermification chemical stripping agent ablation or surgical treatment within 12 months before enrollment; 3) Participants who had used OTC anti-wrinkle products or prescription anti-wrinkle drugs for facial wrinkles in the 28 days prior to enrollment or Subjects who plan to use these products during clinical studies; 4) Patients with serious underlying diseases (such as autoimmune diseases cardiac insufficiency etc.) and those suffering from mental diseases; 5) Patients with pacemakers surgical implants artificial heart and lung; 6) People with abnormal coagulation function and taking anticoagulant drugs or cicatricial constitution or local facial infection or subjects who are allergic to lidocaine and related products and have allergic disease; 7) Pregnant women breastfeeding women and minors; 8) Have received other facial treatments within the past year

Study execute time：

From 2023-02-01

To      2024-03-16

Recruiting time：

From 2023-02-01

To      2024-01-16

Interventions：

36

Group：

Acupuncture

Sample size：

Intervention：

Acupuncture

Intervention code：

36

Group：

TEAS

Sample size：

Intervention：

TEAS

Intervention code：

Total sample size ： 72

Countries of recruitment
and research settings：

Country：

China

Province：

sichuan

City：

chengdu

Institution/hospital：

The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Glogau scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

VISIA data

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

FACE-Q scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

no

Tissue：

Fate of sample 

Destruction after use

Note：

Completed

25
Min age years
50
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Participants who met the inclusion and exclusion criteria were randomly assigned to TEAS acupuncture using a randomization number table generated by Excel by an independent researcher. Patients were unaware of their group assignments. Each patient treatment was conducted in a separate and enclosed space. Study personnel other than the treating staff were unaware of the group assignments. Treatment staff had no role in outcome assessments or data analyses.

Blinding：

Subjects were single-blinded

IPD sharing：

Yes

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

article,2024-12-01

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

no

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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