Diagnosed with breast nodules classified as BI-RADS category 2 or 3, and breast cancer has been ruled out
Conditions
Interventions
Trial group:Take 2 times daily, 2 spoons (20g) each time, either directly or mixed with warm water and stirred before drinking. Continuous use for 2 menstrual cycles.
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
Female
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Breast nodules classified as BI-RADS 2 or 3 based on ultrasound imaging conducted within the past 6 months, with breast cancer ruled out; 2. Palpable surface lumps with pain lasting more than 3 months and not previously treated; 3. Age between 20 and 45 years; 4. No use of hormones or antibiotics within the past 3 months; 5. Voluntarily willing to participate in this trial, sign the informed consent form, and cooperate to complete all tests and follow-ups throughout the trial.
Exclusion criteria
Exclusion criteria: 1. Mastalgia during ovulation or premenstrual period, or breast pain without any lumps; 2. Other breast-related diseases such as breast fibroadenoma or breast cancer; 3. Women who are pregnant, breastfeeding, or postmenopausal; 4. Individuals with severe organic diseases of vital organs such as heart, liver, kidney, or lungs; 5. Those with a history of mental illness, cognitive impairment, or inability to communicate effectively; 6. Individuals who drink >=20g of alcohol per day, smoke >=10 cigarettes, or frequently stay up late (sleep <=5 hours); 7. Those who have participated in other clinical trials in the past 3 months; 8. Individuals with menstrual disorders or irregular menstruation; 9. Those planning to conceive or unable to take effective contraceptive measures during the clinical trial; 10. Others judged by clinical assessment as unsuitable to participate in the trial. Anyone meeting any of the above conditions shall not be enrolled as a participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Breast ultrasound and disease inquiry (including breast pain score, mass size score, breast texture score, and systemic symptoms score);;;Self-Rating Anxiety Scale (SAS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Total Score and Subscale Scores of the Symptom Self-Rating Scale (SCL-90) for Patients with Breast Nodules;Prolactin (PRL);Progesterone (P);Estradiol (E2); | — |
Countries
China
Contacts
Public ContactYang Yang
The Second Hospital of Anhui Medical University
Outcome results
None listed