Breast nodules
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Western Medicine Diagnostic Criteria: Refer to "Evaluation, Diagnosis, and Management of Breast Nodules" and relevant literature on breast nodules for diagnostic standards. Patients with breast nodules confirmed by color Doppler ultrasonography with a maximum diameter =10mm and classified as BI-RADS category 3 or below.Traditional Chinese Medicine Diagnostic Criteria: Refer to the "Diagnostic and Efficacy Standards for TCM Diseases" for the diagnosis of breast nodules: 1) Most nodules are located in the upper outer quadrant of the breast; they feel like small, firm nodules the size of beans, may be tender, and are not adherent to surrounding tissue; 2) The breast may experience swelling and pain, which fluctuates with emotions, often worsening before menstruation and easing afterward; 3) Color Doppler or other examinations can assist in diagnosis.Inclusion Criteria:1) Meet the above diagnostic criteria;2) Nodule maximum diameter =10mm;3) BI-RADS classification category 3 or below;4) Age between 18 and 60 years;5) Informed and voluntarily participating in this clinical study;6) Possess basic cognitive and communication abilities, and can cooperate with completing the assessment scales.
Exclusion criteria
Exclusion criteria: 1) Patients with consciousness disorders or mental illness, or those with diabetes, severe cardiovascular, cerebrovascular, liver, kidney, or other organic damage, immune system diseases, or a history of malignant breast tumors;2) Patients whom the doctor determines require surgical intervention;3) BIRADS category 0, with additional mammography, MRI, or other indications of breast lesions;4) Patients with other malignant tumors requiring surgical treatment;5) People allergic to fungi, pregnant or breastfeeding women;6) Patients currently receiving other medications or participating in related treatment studies that may affect the results of this study;7) Patients with poor compliance with the protocol, deemed by the researcher as unsuitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| breast lump size;texture of breast;breast pain; | — |
Secondary
| Measure | Time frame |
|---|---|
| mental condition; | — |
Countries
China
Contacts
The First Affiliated Hospital of Zhejiang Chinese Medical University