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

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100050886

Enrollment

Unknown

Registered

2021-09-07

Start date

2021-09-01

Completion date

Unknown

Last updated

2022-05-09

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 group:Yanghe decoction 150ml, oral taken twice a day for 3 months

West medicine group:Systemic corticosteroids, immunosuppressive medications and antituberculous drug

Operation group:Abscess drainage and focus clearance by surgery

Breast focus lavage combined with yanghe decoction treatment group:Breast focus lavage(BFL) 2 weeks and combined with Yanghe decoction 150ml, oral taken twice a day for 3 months

Eligibility

Sex/Gender

Female

Age

20 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 20-50 years with pathologically defined GLM and any of the following diagnosis criteria: (1) A severe pain in the breast and the lesion suffuses the entire breast during 1 week; (2) 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; (3) The lesion was larger than 60% of breast and complicated with erythema nodosum, arthralgia, fever, headache and dry cough; (4) Severe breast pain or fetal aplasia in pregnancy patient with GLM; (5) GLM in lactation with breast greater than 60% and severe lactorrhea; (6) 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 are unable to cooperate due to mental illness.

Design outcomes

Primary

Measure	Time frame
Healing Time;Cure rate;Recurrence rate;Time of complications disappearance;The rate of breast appearance change (VS another breast);Visual analogue scale (VAS);Inflammatory mediator;Medical expense;Satisfaction of breast shape change;Quality of life (QOL);	—

Countries

China

Contacts

Public ContactXu Xiaohong

The First Affiliated Hospital of Zhejiang Chinese Medical University

20163329@zcmu.edu.cn+86 13732208336

Outcome results

None listed

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