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Preliminary Exploration of the Mechanism of Xiaoyuan Sanjie Tang in Treating Non-puerperal Mastitis Based on Proteomics Methods

Preliminary Exploration of the Mechanism of Xiaoyuan Sanjie Tang in Treating Non-puerperal Mastitis Based on Proteomics Methods

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079960
Enrollment
Unknown
Registered
2024-01-17
Start date
2024-01-20
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Non-puerperal Mastitis

Interventions

Non-puerperal mastitis patients:Take Xiaoyong Sanjie Decoction and leave the remaining residue for external application to the affected breast. Xiaoyong Sanjie Decoction consists of six traditional Ch
Patients undergoing modified radical mastectomy for breast cancer:None
Breast health volunteers:None

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 49 Years

Inclusion criteria

Inclusion criteria: Non-puerperal mastitis patients: ? Three or more items that meet the diagnostic criteria for traditional Chinese medicine acne mastitis (must meet the first item); ? Pathological diagnosis of non-puerperal mastitis such as plasma cell mastitis or granulomatous lobular mastitis; ? Female patients, aged 18-49 years old; ? Voluntarily participate in this study and sign an informed consent form. Patients undergoing modified radical mastectomy for breast cancer: ? From December 2023 to December 2024, female patients who underwent modified radical surgery for breast cancer in Xiyuan Hospital, China Academy of Chinese Medical Sciences, had normal tissue adjacent to breast cancer (more than 5cm away from breast cancer tissue to ensure that there were no cancer cells left in normal tissue adjacent to cancer); ? Pathological diagnosis of breast cancer; ? No preoperative radiotherapy or chemotherapy was performed; ? Voluntarily participate in this study and sign an informed consent form. Volunteers without breast diseases: ? Women who underwent physical examinations at our hospital from December 2023 to December 2024, aged 18-49 years old, with normal height, body mass, and body mass index (BMI) within the normal range, and vital signs such as blood pressure, pulse, respiration, and body temperature within the normal range or without clinical significance; ? No history of malignant tumors or breast diseases in the past; ? No abnormalities were found during breast specialist examinations conducted by physicians from the Breast Disease Department of Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine; ? The breast ultrasound examination report within the past 3 months shows no obvious abnormalities; ? Voluntarily participate in this study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: Non-puerperal mastitis patients: ? Pregnancy and lactation period; ? Suffering from breast malignant tumors, tuberculosis, and other breast diseases with surgical indications; ?Take contraceptive pills, sex hormone drugs, adrenal glucocorticoid drugs, immunosuppressants, or use contraceptive needles within 3 months before enrollment; ? Serious primary diseases such as heart, liver, kidney, and hematopoietic system, or severe digestive system diseases and autoimmune diseases; ? Allergic constitution or allergic to traditional Chinese medicine ingredients in Xiaoyuan Sanjie Tang; ? Merge acute infections from other systems; ? Pregnancy plan within 3 months; ? Suspected or confirmed history of alcohol and drug abuse, taking psychotropic drugs and other drugs that can cause changes in sex hormone levels; ? Use antibiotics within one week before enrollment. Patients undergoing modified radical mastectomy for breast cancer: ? Suffering from other malignant tumor diseases, hematological disorders, or autoimmune diseases; ? Take contraceptive pills, sex hormone drugs, adrenal glucocorticoid drugs, immunosuppressants, or use contraceptive needles within 3 months before enrollment; ? Concomitant severe underlying diseases such as heart, liver, lungs, and kidneys; ? Mental abnormalities or cognitive impairment; ? Death within one month after surgery; ? Use antibiotics within one week before enrollment. Volunteers without breast diseases: ? Pregnancy and lactation period; ? Take contraceptive pills, sex hormone drugs, adrenal glucocorticoid drugs, immunosuppressants, or use contraceptive needles within 3 months before enrollment; ? Individuals who participate in any drug clinical trial within the first 3 months prior to enrollment; ? Allergic constitution; ? Merge acute infections from other systems; Primary diseases such as heart, liver, kidney, and hematopoietic system, or acute digestive system diseases and autoimmune diseases; ? Use antibiotics within one week before enrollment.

Design outcomes

Primary

MeasureTime frame
proteomics;

Countries

China

Contacts

Public ContactZhang Xiaojun

Xiyuan Hospital of China Academy of Chinese Medical Sciences

zxj6298@sohu.com+86 138 0108 1032

Outcome results

None listed

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