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Multi-omics analysis of the mechanism of non-lactating mastitis and the mechanism of action of XiaoYong Sanjie decoction

Multi-omics analysis of the mechanism of non-lactation mastitis and the mechanism of action of Xiaoyong Sanjie Decoction.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001901
Enrollment
Unknown
Registered
2025-10-15
Start date
2025-04-24
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Non-lactating mastitis

Interventions

Patients with non-lactating mastitis:Oral decoction of Chinese medicine
Breast Health Volunteers:nothing
Patients with modified radical resection of breast cancer:nothing

Sponsors

Xiyuan Hospital China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 49 Years

Inclusion criteria

Inclusion criteria: 1. Patients with non-lactating mastitis (1) Meet more than three diagnostic criteria for acne cradle carbuncle in traditional Chinese medicine (must meet the first item); (2) Non-lactating mastitis such as plasma cell mastitis or granulomatous lobular mastitis diagnosed by pathology; (3) Female patients aged 18-49 years; (4) Voluntarily participate in this study and sign the informed consent form. 2. Patients undergoing modified radical resection of breast cancer (1) Fresh tissue of female patients who underwent modified radical mastectomy in Xiyuan Hospital China Academy of Chinese Medical Sciences and normal tissues adjacent to breast cancer (more than 5cm away from breast cancer tissues to ensure that there are no cancer cells remaining in the normal tissues next to cancer); (2) pathologically clear diagnosis of breast cancer; (3) No radiotherapy or chemotherapy before surgery; (4) Voluntarily participate in this study and sign the informed consent form. 3. Breast health volunteers (1) Women who underwent physical examination in our hospital aged 18-49 years old with height body weight body mass index (BMI) within the normal range blood pressure pulse respiration body temperature and other vital signs within the normal range or no clinical significance; (2) No history of malignant tumors or breast diseases in the past; (3) There were no abnormal findings in the breast examination conducted by the breast specialist of Xiyuan Hospital China Academy of Chinese Medical Sciences; (4) There was no obvious abnormality in the mammosmogram ultrasound report in the past 3 months; (5) Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with non-lactating mastitis (1) Pregnancy and lactation; (2) Breast malignant tumors tuberculosis and other breast diseases with indications for surgery; (3) Taking contraceptives sex hormone drugs adrenal glucocorticoids and immunosuppressants or using contraceptive injections within 3 months before enrollment; (4) Have serious primary diseases such as heart liver kidney and hematopoietic system or severe digestive system diseases and autoimmune diseases; (5) Metabolic diseases such as diabetes obesity hyperlipidemia etc.; (6) Allergic constitution or allergy to the traditional Chinese medicine ingredients in the carbuncle dispersion soup; (7) Acute infection in other systems; (8) Have a pregnancy plan within 4 months; (9) Suspected or confirmed history of alcohol and drug abuse taking psychotropic drugs and other drugs that can cause changes in sex hormone levels; (10) Use of antibiotics within 1 week prior to enrollment. 2. Patients undergoing modified radical resection of breast cancer (1) Suffering from other malignant tumor diseases hematologic diseases or autoimmune diseases; (2) Taking contraceptives sex hormone drugs adrenal glucocorticoids and immunosuppressants within 3 months before enrollment or using contraceptive injections; (3) Combined with serious heart liver lung kidney and other underlying diseases; (4) Mental abnormalities or cognitive insufficiency; (5) Death within 1 month after surgery; (6) Use of antibiotics within 1 week before enrollment. 3. Breast health volunteers (1) Pregnancy and lactation; (2) Taking contraceptives sex hormone drugs adrenocorticosteroid drugs and immunosuppressants or using contraceptive injections within 3 months before enrollment; (3) Those who have participated in any drug clinical trial within 3 months prior to enrollment; (4) allergies; (5) Acute infection combined with other systems; Primary diseases of the heart liver kidney and hematopoietic system or acute diseases of the digestive system and autoimmune diseases; (6) Metabolic diseases such as diabetes obesity and hyperlipidemia; (7) Use of antibiotics within 1 week prior to enrollment; (8) Suspected or confirmed history of alcohol and drug abuse taking psychotropic drugs and other drugs that can cause changes in sex hormone levels.

Design outcomes

Primary

MeasureTime frame
Pain diary;

Secondary

MeasureTime frame
Disease activity index in patients with non-lactating mastitis;

Countries

China

Contacts

Public ContactZHANG Xiaojun

Xiyuan Hospital China Academy of Chinese Medical Sciences

zxj6298@sohu.com13801081032

Outcome results

None listed

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