Register Now
Log In
中文/English
About ITMCTR|Search Trials|About Us|News
A Randomized, controlled clinical observation of acupuncture in the treatment of psychogenic erectile dysfunction (liver-depression and kidney-deficiency type)

Registration number：

ITMCTR2200006679

Date of Last Refreshed on：

2022-10-03

Date of Registration：

2022-10-03

Registration Status：

Prospective registration

Public title：

A Randomized, controlled clinical observation of acupuncture in the treatment of psychogenic erectile dysfunction (liver-depression and kidney-deficiency type)

English Acronym：

Scientific title：

A Randomized, controlled clinical observation of acupuncture in the treatment of psychogenic erectile dysfunction (liver-depression and kidney-deficiency type)

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200064345 ; ChiMCTR2200006679

Applicant：

Wang Hao

Study leader：

Guo Jun

Applicant telephone：

010-62835135

Study leader's telephone：

010-62835134

Applicant Fax：

Study leader's fax：

Applicant E-mail：

wanghao0066@126.com

Study leader's E-mail：

guojun1126@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

1 Xiyuan Playground, Haidian District, Beijing

Study leader's address：

1 Xiyuan Playground, Haidian District, Beijing

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences

Approved by ethic committee：

Approved No. of ethic committee：

2022XLA092-3

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Xiyuan Hospital, China Academy of Chinese Medical Sciences

Date of approved by ethic committee：

2022/6/30 0:00:00

Contact Name of the ethic committee：

Contact Address of the ethic committee：

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences

Primary sponsor's address：

1 Xiyuan Playground, Haidian District, Beijing

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences

Address：

1 Xiyuan Playground, Haidian District, Beijing

Source(s) of funding：

the Hundred Million Talent Project of Chinese Medicine Inheritance and Innovation of the State Administration of Traditional Chinese Medicine (QI Huang Scholars Grant 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：

To evaluate the effectiveness and safety of acupuncture in the treatment of psychogenic erectile dysfunction (liver-depression and kidney-deficiency type).

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1.Those who meet the psychogenic ED diagnostic criteria. 2.Those who meet the criteria for the identification of liver depression and kidney deficiency in Chinese medicine. 3.8≤IIEF-5≤21. 4.20-50 years old male. 5.Have a regular sexual partner and a stable sex life, and ensure sex life≥1 time/week during treatment. 6.Accept and sign the informed consent form.

Exclusion criteria：

1.Patients with drug-related ED or organic ED. 2.Patients with abnormalities of the genitourinary system. 3.Patients with genitourinary infections. 4.Patients with neurological disorders or serious organic diseases. 5.SAS > 69 or SDS > 72 or unable to guarantee discontinuation of anti-anxiety or depression medication during the trial. 6.Patients with coagulation disorders. 7.Patients with hypogonadism. 8.Patients with hypothyroidism. 9.Patients with other serious systemic diseases. 10.Spouse with serious systemic illness or pregnancy who is unable to cooperate. 11.Patients have taken any ED treatment medication within 1 month prior to study entry. 12.Patients are using other drugs related to the disease under study.

Study execute time：

From 2022-06-30

To      2023-06-29

Recruiting time：

From 2022-10-03

To      2023-06-29

Interventions：

33

Group：

Acupuncture group

Sample size：

Intervention：

Acupuncture

Intervention code：

33

Group：

sham acupuncture group

Sample size：

Intervention：

Non-acupuncture point shallow stab

Intervention code：

Total sample size ： 66

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Institution/hospital：

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Level of the institution：

Tertiary A

Outcomes：

Outcome：

International Index of Erectile Function-5

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Chinese Medicine Symptom Score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Sexual Encounter Profile question2

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

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：

Erection Hardness Score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Sexual Encounter Profile question3

Type：

Secondary 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
50
Max age years

Recruiting status：

Participant age：

Gender：

Male

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

Using SAS statistical software, a random number grouping table was generated according to the number of cases assigned and the random proportion.

Blinding：

IPD sharing：

No

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

no

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

no

Data Managemen Committee：

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

back
Platform information
About ITMCTR
About Us
Register Trials
Frequently Asked Questions
Ethical Review
The public service
Search Trials
Join Us
ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above