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Clinical Observation of Yiqi Joint Venture Traditional Chinese Medicine Combined with Precise Minimally Invasive Debridement in the Treatment of Granulomatous Lobular Mastitis

Registration number：

ITMCTR2100005217

Date of Last Refreshed on：

2021-08-26

Date of Registration：

2021-08-26

Registration Status：

Prospective registration

Public title：

Clinical Observation of Yiqi Joint Venture Traditional Chinese Medicine Combined with Precise Minimally Invasive Debridement in the Treatment of Granulomatous Lobular Mastitis

English Acronym：

Scientific title：

Study on the Clinical Efficacy and Standardized Scheme of Hormone Therapy for Granulomatous Mastitis

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2100050368 ; ChiMCTR2100005217

Applicant：

Liu Xiaofei

Study leader：

Liu Xiaofei

Applicant telephone：

+86 15615611377

Study leader's telephone：

+86 15615611377

Applicant Fax：

Study leader's fax：

Applicant E-mail：

drliuxf@126.com

Study leader's E-mail：

drliuxf@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

42 Wenhua Road West, Lixia District, Ji'nan, Shandong

Study leader's address：

42 Wenhua Road West, Lixia District, Ji'nan, Shandong

Applicant postcode：

Study leader's postcode：

Applicant's institution：

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

（2020）伦审第（054）号-KY

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Date of approved by ethic committee：

2020/12/31 0:00:00

Contact Name of the ethic committee：

Zhang Xin

Contact Address of the ethic committee：

42 Wenhua Road West, Lixia District, Ji'nan, Shandong

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Primary sponsor's address：

42 Wenhua Road West, Lixia District, Ji'nan, Shandong

Secondary sponsor：

Country：

China

Province：

Shandong

City：

Ji'nan

Institution
hospital：

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Address：

42 Wenhua Road West, Lixia District

Source(s) of funding：

Shandong medical and health science and technology development plan project

Target disease：

Granulomatous lobular mastitis

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

To observe and compare the clinical efficacy of the control group and hormone treatment group, analyze the effectiveness and safety of hormone therapy, clarify the suitable population and indications of hormone therapy, formulate a reasonable treatment cycle, improve the comprehensive internal and external treatment plan, and establish the medication standard of hormone therapy.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. Non pregnant and lactating female patients; 2. The pathological diagnosis was granulomatous mastitis in the stage of mass or abscess; 3. Female patients over 18 years old (including 18 years old) and under 50 years old; 4. Volunteer to participate in the trial and sign the informed consent; 5. Be able to cooperate with researchers to complete the investigation.

Exclusion criteria：

1. TB infected T cells (ESAT-6, CFP-10), PDD tuberculin test suspected breast tuberculosis patients; 2. Unable to take hormone due to physical or other reasons; 3. Patients with other immune related diseases; 4. Patients with severe primary diseases such as cardiovascular, cerebrovascular, kidney, liver, endocrine system and hematopoietic system, mental patients, or mental or legal disabilities; 5. According to the judgment of the researchers, other diseases that reduce the possibility of enrollment or complicate the enrollment, such as frequent changes in the working environment, are likely to cause loss of follow-up, and those who cannot give full informed consent due to mental and behavioral disorders.

Study execute time：

From 2021-09-01

To      2022-09-01

Recruiting time：

From 2021-09-01

To      2022-07-31

Interventions：

60

Group：

Hormone therapy group

Sample size：

Intervention：

Yiqi Joint Venture and hormone

Intervention code：

60

Group：

Control group

Sample size：

Intervention：

Yiqi Joint Venture

Intervention code：

Total sample size ： 120

Countries of recruitment
and research settings：

Country：

China

Province：

Shandong

City：

Institution/hospital：

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Duration of disease

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Recurrence rate

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Patient satisfaction after cure

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Ultrasound imaging of breast

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

The effective rate of conservative treatment

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Operation method

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

laboratory examination

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Breast symptoms

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

The aesthetic degree of breast appearance

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

pus

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
50
Max age years

Recruiting status：

Participant age：

Gender：

Female

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

120 patients with granulomatous mastitis in mass stage and early abscess stage were randomly divided into two groups.

Blinding：

IPD sharing：

Yes

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

2022-09-30

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

Case Record Form, CRF Electronic Data Capture, EDC

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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