Confirmed breast nodules with BI-RADS categories 2 and 3, and have been ruled out for breast cancer.
Conditions
Interventions
Experimental Group:Twice daily, take 2 scoops (20g) each time. You can take it directly or mix it with warm water and stir well before drinking. Continue taking it for 2 consecutive menstrual cycles.
Sponsors
Anhui Medical University Second Affiliated Hospital
Eligibility
Sex/Gender
Female
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Patients with breast nodules classified as BI-RADS grade 2 or 3 confirmed by color Doppler ultrasound within the past 6 months, excluding those with breast cancer; (2) Patients with palpable masses and pain lasting more than 3 months without prior treatment; (3) Patients aged between 20 and 45 years; (4) Patients who have not taken hormonal medications or antibiotics within the past 3 months; (5) Patients who voluntarily participate in this trial, sign the informed consent form, and are willing to cooperate with all trial-related examinations and follow-ups.
Exclusion criteria
Exclusion criteria: (1) Breast tenderness during ovulation or the premenstrual phase, or mastalgia without any palpable lump; (2) Other breast-related diseases such as breast tumors or breast cancer; (3) Pregnant, breastfeeding, or postmenopausal women; (4) Individuals with severe organic diseases of important organs such as the heart, liver, kidneys, or lungs; (5) Those with a history of mental illness, cognitive impairments, or inability to communicate effectively; (6) Individuals who consume =20g of alcohol daily, smoke =10 cigarettes per day, or have a history of chronic sleep deprivation (=5 hours of sleep per night); (7) Those who have participated in other clinical trials within the past 3 months; (8) Individuals with menstrual irregularities or menstrual disorders; (9) Those planning to conceive or unable to adhere to contraceptive measures during the clinical trial; (10) Other individuals deemed unsuitable for participation based on clinical assessment. If any of the above conditions are met, the individual should not be enrolled as a participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Breast ultrasound and disease consultation (including breast pain score, lump size score, breast texture score, and general symptoms score);; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total score and subscale scores of the Symptom Checklist-90 (SCL-90) for patients with breast nodules.;Self-Rating Anxiety Scale (SAS);Prolactin (PRL);Progesterone (P);Estradiol (E2); | — |
Countries
China
Contacts
Public ContactYang Yang
Anhui Medical University Second Affiliated Hospital
Outcome results
None listed