Clinical efficacy of Qianmitong in the treatment of Chronic prostatitis with qi-stagnancy and blood stasis Syndrome

Registration number:

ITMCTR2100004846

Date of Last Refreshed on:

2021-05-14

Date of Registration:

2021-05-14

Registration Status:

Prospective registration

Public title:

Clinical efficacy of Qianmitong in the treatment of Chronic prostatitis with qi-stagnancy and blood stasis Syndrome

English Acronym:

Scientific title:

Clinical efficacy of Qianmitong in the treatment of Chronic prostatitis with qi-stagnancy and blood stasis Syndrome

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

ChiCTR2100046366 ; ChiMCTR2100004846

Applicant:

Li Fuhao

Study leader:

Chang Degui

Applicant telephone:

+86 15528434004

Study leader's telephone:

+86 18980880133

Applicant Fax:

Study leader's fax:

Applicant E-mail:

lfh960901@163.com

Study leader's E-mail:

624440310@qq.com

Study leader's website(voluntary supply):

成都中医药大学附属医院

Study leader's website
(voluntary supply):

Applicant address:

39 Twelfth Bridge Road, Jinniu District, Chengdu, Sichuan

Study leader's address:

39 Twelfth Bridge Road, Jinniu District, Chengdu, Sichuan

Applicant postcode:

610072

Study leader's postcode:

610072

Applicant's institution:

Hospital of Chengdu University of Traditional Chinese Medicine

Approved by ethic committee:

Approved No. of ethic committee:

2021KL-032

Approved file of Ethical Committee:

View

Name of the ethic committee:

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

Date of approved by ethic committee:

2021/4/28 0:00:00

Contact Name of the ethic committee:

He Chengshi

Contact Address of the ethic committee:

39 Twelfth Bridge Road, Jinniu District, Chengdu, Sichuan

Contact phone of the ethic committee:

Contact email of the ethic committee:

Primary sponsor:

Hospital of Chengdu University of Traditional Chinese Medicine

Primary sponsor's address:

39 Twelfth Bridge Road, Jinniu District, Chengdu, Sichuan

Secondary sponsor:

Country:

China

Province:

Sichuan

City:

Chengdu

Institution
hospital:

Hospital of Chengdu University of Traditional Chinese Medicine

Address:

39 Twelfth Bridge Road, Jinniu District

Source(s) of funding:

Key Research projects of Sichuan Provincial Department of Science and Technology

Target disease:

Chronic prostatitis

Target disease code:

Study type:

Interventional study

Study design:

randomized controlled trial(parallel group design)

Study phase:

Others

Objectives of Study:

A randomized, controlled, double-blind method was used to evaluate the efficacy and safety of Qianmitong in clinical use, and to explore the mechanism of Qianmitong in the treatment of chronic prostatitis. It not only provides a safe and reliable choice of drugs for clinical treatment of chronic prostatitis, but also provides clinical basis for further development and application of Qianmitong.

Description for medicine or protocol of treatment in detail:

Inclusion criteria

1. Those who meet the diagnostic criteria of chronic prostatitis can be used as test cases; 2. Age between 18-50 years old; 3. Those who have received treatment stop using all related drugs for the treatment of prostatitis for more than 2 weeks; 4. Volunteer to participate in the treatment and sign the trial informed consent.

Exclusion criteria:

1. Complicated with abnormal development of the genitourinary system; 2. Accompanied by diseases such as urinary tract infection and prostate tuberculosis; 3. Accompanied by prostate hyperplasia, prostate tumor, severe neurosis and other diseases; 4. Other diseases in the lower abdomen, perineum, lumbosacral and other parts with local pain as the main manifestation have not been ruled out; 5. Combined with severe cardiovascular and cerebrovascular diseases, liver and kidney insufficiency, and mental illness; 6. Other situations where it is not possible to participate in the research in the whole process.

Study execute time:

From 2021-05-01

To      2022-05-01

Recruiting time:

From 2021-05-15

To      2022-04-15

Interventions:

73

Group:

Treatment group

Sample size:

Intervention:

Qianmitong tablet + tamsulosin hydrochloride sustained release capsule placebo

Intervention code:

73

Group:

Control group

Sample size:

Intervention:

Tamsulosin hydrochloride sustained release capsule + Qianmitong tablet placebo

Intervention code:

Total sample size : 146

Countries of recruitment
and research settings:

Country:

China

Province:

Sichuan

City:

Chengdu

Institution/hospital:

Hospital of Chengdu University of Traditional Chinese Medicine

Level of the institution:

Tertiary A

Outcomes:

Outcome:

Prostatic fluid cell influencing factor

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

Chronic prostatitis symptom index

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

Expressed prostatic secretion

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Adverse Events

Type:

Adverse events

Measure time point of outcome:

Measure method:

Outcome:

TCM syndrome score table

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Collecting sample(s)
from participants:

Sample Name:

Expressed prostatic secretion

Tissue:

Prostate

Fate of sample 

Destruction after use

Note:

Not yet recruiting

18
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):

The patients with prostatitis in the clinic were divided into groups according to the principle of randomization. With the help of the SAS statistical software PROC PLAN process statement, given the number of seeds, a random arrangement for the number of subjects to be processed is generated, that is, t

Blinding:

(1) Drug packaging and distribution: Qianmitong tablets and tamsulosin hydrochloride sustained-release capsule placebo were made by double-blind method, and the drugs were repackaged and distributed according to the standardized procedure of double-blind clinical trial. (2) the blind bottom preservation regulations: the blind bottom shall be designed by blind method and sealed in duplicate, which shall be stored in the office of the drug clinical trial institution of the trial unit and the applicant unit respectively.

IPD sharing:

Yes

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

contact with the study leader through e-mail.

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

Case Record Form+excel-e-case repord form

Data Managemen Committee:

No

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

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above