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Effect and mechanism of Acupuncture (Jin's three-needle) for patients with mild to moderate depression

Registration number：

ITMCTR2024000872

Date of Last Refreshed on：

2024-12-27

Date of Registration：

2024-12-27

Registration Status：

Prospective registration

Public title：

Effect and mechanism of Acupuncture (Jin's three-needle) for patients with mild to moderate depression

English Acronym：

Scientific title：

Effect and mechanism of Acupuncture (Jin's three-needle) for patients with mild to moderate depression

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Hao Wen

Study leader：

Hao Wen

Applicant telephone：

+86 15876576899

Study leader's telephone：

+86 15876576899

Applicant Fax：

Study leader's fax：

Applicant E-mail：

wenhaophd@outlook.com

Study leader's E-mail：

wenhaophd@outlook.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 3 Xieshan Road Huangpu District Guangzhou Guangdong China

Study leader's address：

No. 3 Xieshan Road Huangpu District Guangzhou Guangdong China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Traditional Chinese Medicine Hospital of Huangpu District

Approved by ethic committee：

Approved No. of ethic committee：

TCMHHP-2024-1201-01

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics committee of Traditional Chinese Medicine Hospital of Huangpu District

Date of approved by ethic committee：

2024/12/1 0:00:00

Contact Name of the ethic committee：

Minhua Chen

Contact Address of the ethic committee：

No. 3 Xieshan Road Huangpu District Guangzhou Guangdong China

Contact phone of the ethic committee：

+86 020-82100041

Contact email of the ethic committee：

cmh1355@163.com

Primary sponsor：

Traditional Chinese Medicine Hospital of Huangpu District

Primary sponsor's address：

No. 3 Xieshan Road Huangpu District Guangzhou Guangdong China

Secondary sponsor：

Country：

China

Province：

Guangdong

City：

Guangzhou

Institution
hospital：

Traditional Chinese Medicine Hospital of Huangpu District

Address：

No. 3 Xieshan Road Huangpu District Guangzhou Guangdong China

Source(s) of funding：

Major Scientific and Technological Project of Traditional Chinese Medicine in Guangzhou Region（2025QN018）

Target disease：

Depression

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

To further clarify the clinical efficacy and safety of acupuncture (Jin's three-needle) in the treatment of mild to moderate depression and conduct transcriptome and whole-genome DNA methylation analyses to further investigate the underlying mechanisms of Acupuncture (Jin's three-needle) in treating mild to moderate depression

Description for medicine or protocol of treatment in detail：

Inclusion criteria

①Meet the diagnostic criteria for depression in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) with a HAMD-17 score between 8 and 25points; ② Patients aged 18-45years regardless of gender; ③Patients are voluntary and able to sign informed consent.

Exclusion criteria：

① bipolar depression treatment-resistant depression suicidal tendency (HAMD third score greater than 2 points); ② Immediate family or personal history of mental illness; ③Serious physical health (as assessed by a doctor); ④ Positive pregnancy test; ⑤ Receive acupuncture treatment within three months.

Study execute time：

From 2025-01-01

To      2027-12-31

Recruiting time：

From 2025-01-01

To      2026-12-31

Interventions：

53

Group：

Sham acupuncture

Sample size：

Intervention：

Sham acupuncture

Intervention code：

53

Group：

Acupuncture group

Sample size：

Intervention：

Acupuncture (Jin's three-needle)

Intervention code：

Total sample size ： 106

Countries of recruitment
and research settings：

Country：

China

Province：

Guangdong

City：

Guangzhou

Institution/hospital：

Traditional Chinese Medicine Hospital of Huangpu District

Level of the institution：

Second-grade class-A hospital

Country：

China

Province：

Guangdong

City：

Foshan

Institution/hospital：

The Affiliated Shunde Hospital of Jinan University

Level of the institution：

third-grade class-A hospital

Outcomes：

Outcome：

TCM syndrome scoring scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Self-Rating Anxiety Scale（SAS）

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Self-rating depression scale（SDS）

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

PSQI (Pittsburgh sleep quality index)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Hamilton Anxiety Scale（HAMA ）

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

HAMD (Hamilton Depression Scale)

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：

Not yet recruiting

18
Min age years
45
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Subjects will be randomly assigned 1:1 to the acupuncture group and the sham acupuncture group using the central random assignment method. The program will be written and randomized 1:1 by the specialized staff of the hospital clinical research center using SAS 9.4 software. Each clinical research center receives a random number according to the application random coding process until the total number of observed cases is completed.

Blinding：

IPD sharing：

Yes

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

The research data will be published in the form of a paper within 2 years after the completion of clinical trials.

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

CRF is used for data acquisition and management

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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