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Based on acupuncture treatment of ED acupoint selection program research and efficacy evaluation

Registration number：

ITMCTR2200005763

Date of Last Refreshed on：

2022-03-26

Date of Registration：

2022-03-26

Registration Status：

Prospective registration

Public title：

Based on acupuncture treatment of ED acupoint selection program research and efficacy evaluation

English Acronym：

Scientific title：

Based on acupuncture treatment of ED acupoint selection program research and efficacy evaluation

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200057998 ; ChiMCTR2200005763

Applicant：

Quan Fei

Study leader：

Cui Jin

Applicant telephone：

+86 15585107127

Study leader's telephone：

+86 13985026278

Applicant Fax：

Study leader's fax：

Applicant E-mail：

2417891021@qq.com

Study leader's E-mail：

516260179@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

50 Shidong Lu, Guiyang city, Guizhou Province

Study leader's address：

50 Shidong Lu, Guiyang city, Guizhou Province

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Guizhou University of Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

KY-2022031

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of the First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

Date of approved by ethic committee：

2022/1/7 0:00:00

Contact Name of the ethic committee：

Liuyang

Contact Address of the ethic committee：

71 Baoshan Bei Lu, Yunyan District, Guiyang city, Guizhou Province, China

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

Guizhou University of Chinese Medicine

Primary sponsor's address：

Guizhou University of Traditional Chinese Medicine, 50 Shidong Road, Guiyang city, Guizhou Province

Secondary sponsor：

Country：

China

Province：

Guizhou

City：

Guiyang

Institution
hospital：

The First Affiliated Hospital of Guizhou University of Chinese Medicine

Address：

71 Baoshan North Road, Yunyan District

Source(s) of funding：

Postgraduate project

Target disease：

Erectile dysfunction

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

1. To verify the clinical efficacy of acupuncture in the treatment of ED from subjective scale by observing IIEF-5(International Erectile Function Questionnaire), TCM clinical syndrome score, SAS and SDS before and after treatment; 2. Verify the clinical effect of acupuncture on ED by observing the serum testosterone level (T) before and after treatment. 3. To evaluate the safety of acupuncture for ED by observing and recording adverse events.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

① Meet the above diagnostic criteria; ② History ≥3 months, IIEF score between 5-21; ③ Age 20-55; ④ Have a regular sexual partner of more than 3 months; ⑤ The subjects did not receive any treatment related to the disease within 4 weeks before the test; ⑥ The serum testosterone level is normal or decreased; 7. Those with good compliance agreed to participate in the experiment and signed informed consent; Note: those who meet the above 7 criteria can be included in this study.

Exclusion criteria：

① Those who do not meet the diagnostic criteria for appeal and inclusion criteria; ② There is obvious organic damage; ③ Complicated with serious cardiovascular and cerebrovascular diseases or other liver, kidney, blood, endocrine diseases and mental diseases; ④ The spouse suffers from serious organic disease and cannot cooperate fully; ⑤ Those who need nitrate drugs for a long time or are using them; ⑥ Those who are allergic to the drugs in this study; ⑦ Poor compliance, poor efficacy determination; Note: Subjects who meet any of the above criteria will not be included in this study.

Study execute time：

From 2022-01-01

To      2023-06-30

Recruiting time：

From 2022-03-11

To      2023-03-31

Interventions：

30

Group：

The control group

Sample size：

Intervention：

Western medicine

Intervention code：

30

Group：

Experimental group

Sample size：

Intervention：

acupuncture

Intervention code：

Total sample size ： 60

Countries of recruitment
and research settings：

Country：

China

Province：

Guizhou

City：

Guiyang

Institution/hospital：

The First Affiliated Hospital of Guizhou University of Chinese Medicine

Level of the institution：

The top three

Outcomes：

Outcome：

Self-rating Anxiety Scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Self-rating Depression Scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Serum testosterone（T）

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

TCM clinical syndrome integral

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

International Erectile Function Questionnaire

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

20
Min age years
55
Max age years

Recruiting status：

Participant age：

Gender：

Male

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

Using excel random number table method, 60 random numbers were generated, divided into 2 groups on average, and the grouping of each serial number was determined, with 30 subjects in each group. The codes representing different treatment plans (① and ②) were put into corresponding opaque envelopes with seri

Blinding：

IPD sharing：

Yes

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

Date of disclosure of raw data; Public within 6 months after the completion of the test; Public content: original recorded data and research proposal. 修改翻译结果

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

Data collection by professional data collectors; The research group will remain intact.

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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