Efficacy of ' Zhixiangpi and Baizhi Medicated Thread ' drainage in the treatment of granulomatous mastitis in abscess stage

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2200005819

Enrollment

Unknown

Registered

2022-04-06

Start date

2022-03-23

Completion date

Unknown

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Granulomatous lobular mastitis

Interventions

treatment group:Treatment of GLM in Abscess Stage with "Zhixiangpi and Baizhi Medicated Thread" Drainage

control group:Treatment of GLM with "sterile rubber drainage strip"in abscess stage

Eligibility

Sex/Gender

Female

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: ( 1 ) The clinical symptoms were inflammation, color ultrasound examination and breast masses were punctured by color ultrasound-guided core biopsy needle, and pathological examination confirmed GLM ; ( 2 ) The clinical symptom stage is abscess stage ; ( 3 ) Breast skin without damage ; ( 4 ) Non-lactation onset, female ; ( 5 ) The affected breast is single pus cavity, or multiple pus cavity with pus cavity number = 2 ; ( 6 ) Mass with obvious fluctuation, without breast incision and drainage before admission ; ( 7 ) The informed consent of the patient and the voluntary signing of the informed agreement by the patient meet the basic requirements of the Ethics Committee.

Exclusion criteria

Exclusion criteria: ( 1 ) Women in pregnancy or lactation ; ( 2 ) The local skin of the breast becomes thinner, which is estimated by our group of clinicians to be broken within 10 days ; ( 3 ) Patients with previous primary diseases such as heart and lung, liver and kidney, tuberculosis ; ( 4 ) Patients with breast surgery or hormone therapy in recent 3 months ; ( 5 ) Patients with breast cancer ; ( 6 ) Poor compliance or a history of mental illness, unable to cooperate with treatment and follow-up ; ( 7 ) Patients with severe primary diseases such as heart and lung, liver and kidney, tuberculosis ; ( 8 ) Those who received other drugs within 3 months or had evidence of drug abuse or dependence recently.

Design outcomes

Primary

Measure	Time frame
Tumor Size;	—

Secondary

Measure	Time frame
CD4/CD8;Degree of breast pain;CD3(+)CD8(+);complement C4;CD3(+);Local skin color of breast;complement C3;IgA;Lymphocyte Count;CD3(+)CD8(+);C-reactive protein;IgG;IgG;	—

Countries

The People's Republic of China

Contacts

Public ContactCheng Xufeng

cxf9939@163.com13937189939

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026