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Observation on the clinical efficacy of the "Harmonising Rongwei" acupuncture method in the treatment of chloasma in the Difficult Classic

Registration number：

ITMCTR2024000339

Date of Last Refreshed on：

2024-08-31

Date of Registration：

2024-08-31

Registration Status：

Retrospective registration

Public title：

Observation on the clinical efficacy of the "Harmonising Rongwei" acupuncture method in the treatment of chloasma in the Difficult Classic

English Acronym：

Scientific title：

Observation on the clinical efficacy of the "Harmonising Rongwei" acupuncture method in the treatment of chloasma in the Difficult Classic

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Xiaofan Zhao

Study leader：

Wenguang Hou

Applicant telephone：

14782651672

Study leader's telephone：

13564567336

Applicant Fax：

Study leader's fax：

Applicant E-mail：

fannezhao@163.com

Study leader's E-mail：

houwenguang@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

110 Ganhe Road Hongkou District Shanghai China

Study leader's address：

110 Ganhe Road Hongkou District Shanghai China

Applicant postcode：

200437

Study leader's postcode：

200437

Applicant's institution：

Yueyang Hospital of Integrative Medicine Shanghai University of Traditional Chinese Medicine China

Approved by ethic committee：

Approved No. of ethic committee：

2024-043

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee Yueyang Hospital of Integrative Medicine Shanghai University of Traditional Chinese Medicine China

Date of approved by ethic committee：

2024/3/25 0:00:00

Contact Name of the ethic committee：

Congquan Yin

Contact Address of the ethic committee：

110 Ganhe Road Hongkou District Shanghai China

Contact phone of the ethic committee：

02165161782

Contact email of the ethic committee：

yyyyllwyh@126.com

Primary sponsor：

Yueyang Hospital of Integrative Medicine Shanghai University of Traditional Chinese Medicine China

Primary sponsor's address：

110 Ganhe Road Hongkou District Shanghai China

Secondary sponsor：

Country：

China

Province：

Shanghai

City：

Hongkou District

Institution
hospital：

Yueyang Hospital of Integrative Medicine Shanghai University of Traditional Chinese Medicine China

Address：

110 Ganhe Road Hongkou District Shanghai China

Source(s) of funding：

Yueyang Hospital of Integrative Medicine Shanghai University of Traditional Chinese Medicine China

Target disease：

chloasma

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

To objectively evaluate the therapeutic efficacy and safety of the Harmonising Rongwei acupuncture method of the Classic of Difficulties in the treatment of chloasma and to provide a reference basis for the clinical use of the Harmonising Rongwei acupuncture method of the Classic of Difficulties in the treatment of chloasma.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

① Those who meet the above diagnostic criteria of butterfly chloasma in Chinese and western medicine; ② Those who are ≥18 years old and ≤49 years old female; ③ Those who have not used any method to treat chloasma one month before treatment; ④ The skin lesions have no obvious signs of infection; ⑤ Agree not to use any other treatment (including drugs) by themselves during the treatment; ⑥ Patients understood and agreed to participate in this study and signed the informed consent form.

Exclusion criteria：

①Patients with localised pigmentation caused by other reasons; ② Suffering from other serious visceral system diseases (heart liver lung kidney brain etc.) or mental disorders; ③Patients with diseases related to coagulation disorders; ④Pregnant and breastfeeding women; ⑤ People with skin ulcers or infections in the pigmented areas; ⑥Allergic or allergic to acupuncture needles needle fainting or fear of pain; ⑦ Exposure to sunlight for more than 3 hours or more per day.

Study execute time：

From 2024-03-26

To      2024-12-31

Recruiting time：

From 2024-03-26

To      2024-12-31

Interventions：

39

Group：

treatment group

Sample size：

Intervention：

acupuncture

Intervention code：

39

Group：

control group

Sample size：

Intervention：

sham-acupuncture

Intervention code：

Total sample size ： 78

Countries of recruitment
and research settings：

Country：

China

Province：

Shanghai

City：

Hongkou District

Institution/hospital：

Yueyang Hospital of Integrative Medicine Shanghai University of Traditional Chinese Medicine China

Level of the institution：

110 Ganhe Road Hongkou District Shanghai China

Outcomes：

Outcome：

Body surface infrared thermography

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Dermatological Quality of Life Index

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Patient satisfaction

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Skin lesion symptom score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Melasma Area and Severity Rating Scale

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

none

Tissue：

Fate of sample 

Others

Note：

Recruiting

18
Min age years
49
Max age years

Recruiting status：

Participant age：

Gender：

Female

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

The SPSS 25.0 random number generator was used to generate 78 random numbers between 0-1 corresponding to serial numbers 1-78 and the random numbers were divided into two groups using visual split-boxing so that their corresponding serial numbers were automatically divided into two groups and the results of the randomised grouping were sealed in envelopes which were opened in the order of attendance after the subjects entered the study thus randomly dividing them into the test group and the control group. The randomisation protocol for this trial was carried out by a full-time randomiser who was not involved in the evaluation.

Blinding：

IPD sharing：

No

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

none

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

Case Record Form CRF

Data Managemen Committee：

Yes

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

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