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Breast focus lavage combined with yanghe decoction treatment for refractory granulomatous lobular mastitis:a randomized,controlled,multi-center study

Breast focus lavage combined with yanghe decoction treatment for refractory granulomatous lobular mastitis :a randomized,controlled,multi-center study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005281
Enrollment
Unknown
Registered
2021-09-07
Start date
2021-09-01
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

Refractory granulomatous lobular mastitis

Interventions

Yanghe decoction:150 mL Yanghe decoction 2/d x 3 m
Breast focus lavage combined with yanghe decoction treatment :Breast focus lavage(BFL) 2W
Yanghe decoction 2/dX3Mmbined with yanghe decoction treatment
operation group:abscess drainage and focus clearance
west medicine group:systemic corticosteroids, immunosuppressive medications and antituberculous drug
ADCB

Sponsors

The first affiliated hospital,Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) patients aged 20-50 years with pathologically defined GLM and any of the following diagnosis criteria : ?.A severe pain in the breast and the lesion suffuses the entire breast during 1 week, ?.GLM recurrence or serious side effects after treatments with systemic corticosteroids, immunosuppressive drugs , antituberculous drugs ,traditional Chinese medicine and surgery interferences, with the lesion still beyond 60% of the breast, ?.The lesion was larger than 60% of breast and complicated with erythema nodosum, arthralgia, fever, headache and dry cough; ?.severe breast pain or Fetal aplasia in pregnancy patient with GLM ?.GLM in lactation with breast greater than 60% and severe Lactorrhea ?.GLM in bilateral breasts with simultaneous breast lesion greater than 60% of unilateral breast, 2) Informed consent was obtained from patients and informed consent was signed; 3) Those who can complete the treatment according to the prescribed treatment plan.

Exclusion criteria

Exclusion criteria: 1)Other clinical researchers participated in the same period; 2)Those who fail to discharge as required; 3)Those who refuse to sign the informed consent 4)Those who refuse to cooperate or are unable to cooperate due to mental illness;

Design outcomes

Primary

MeasureTime frame
Inflammatory mediator;LOQ;Cure rate;The rate of breast appearance change (VS another breast);Healing Time;VAS;Recurrence rate;medical expense;Time of complications disappearance;Satisfaction of breast shape change;—

Countries

China

Contacts

Public Contactxiaohong xu

The first affiliated hospital,Zhejiang Chinese Medical University

20163329@zcmu.edu.cn13732208336

Outcome results

None listed

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