Clinical study on the treatment of non-lactation mastitis in ulcerative stage with warm compress of Wentongxiaoyong formula

Phase 1

• Conditions: non-lactation mastitis

• Registration Number: ITMCTR2200006410
• Lead Sponsor: Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1.TCM diagnostic criteria
Referring to the 2012 Guidelines for Diagnosis and Treatment of Common Diseases in Traditional Chinese Medicine Surgery, the diagnostic criteria for acne mastitis:
1.1 Clinical manifestations:
Mostly in women who are not lactating or non-pregnant, unilateral breast disease is more common, and most of them are accompanied by congenital nipples that are all or partially sunken, and have white and smelly powder-like secretions. The clinical manifestations are complex and diverse, and are often divided into discharge stage, mass stage, suppurative stage, and fistula stage. The initial mass was located in the areola, red, swollen, painful, and purulent. After the rupture, the pus is mixed with powder and slag-like substances, and the mouth does not close for a long time;If the attack is repeated, scarring is formed, and there is residual stiffness, the nipple depression will be more obvious. Symptoms such as mild aversion to cold and fever are generally associated with redness, swelling and purulence.
1.2 Auxiliary inspection:
Laboratory tests: Serum prolactin levels were significantly increased in some cases. Imaging examination: B-ultrasound: Irregular sheet-like hypoechoic and enhanced light spots are seen in the lesion. If there are multiple hypoechoic spots, it means that the fistulas can be connected to each other.Mammographic mammography: There are unevenly increased density shadows around the areola and other parts, the boundary is unclear, there are cord-like dense shadows, and the skin around the areola is thickened. CT enhancement: see heterogeneous enhancement, low density shadow in the lesion. Pathological examination: fine needle aspiration cytology examination of breast mass: a variety of cells can be seen mixed, mainly inflammatory cells, and other inflammatory cells.
2 Western medicine diagnostic criteria
Based on pathological examination, the mammary ducts were highly dilated under MDE/PDM, and the cysts were filled with pink granular thick substances; lymphocytes, plasma cells and neutrophils were infiltrated around the dilated ducts.
The most prominent feature of GLM is noncaseating granulomas centered on the lobular unit of the mammary gland, which are multifocal in distribution and vary in size, with or without microabscesses.
3 Inclusion criteria
? Patients who meet three or more of the above-mentioned diagnostic criteria for acne mammary carbuncle (must meet the first item) at the same time in Xiyuan Hospital;
?The pathological diagnosis of non-lactation mastitis such as plasma cell mastitis or granulomatous lobular mastitis;
? Female patients, aged 18-49;
? The lesion is in the stage of rupture (including the rupture has not healed, or the incision has not healed after surgery, drainage, etc.);
? Agree to participate in this clinical trial and be willing to cooperate with the completion of this research.

Exclusion Criteria

? Pathologically confirmed that the tissue contains tuberculosis and malignant tumor cells;
? Pregnancy and lactation;
? Participate in other clinical investigators at the same time;
? Severe heart, liver and kidney dysfunction;
? Serious mental illness;
? Both breasts suffer from non-lactation mastitis at the same time.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
lump;wound surface;

Secondary Outcome Measures

Name	Time	Method
skin color;pain;