mammary gland hyperplasia with breast pain
Conditions
Interventions
Control group:The placebo of Danlu capsules was administered orally with a dosage form of 0.5 g per capsule 2.0 g per administration and three times daily.
Treatment group:Danlu capsules were administered orally with the approval number Z20150004 from the National Medical Products Administration. The dosage form is 0.5 g per capsule 2.0 g per administrat
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged between 18 and 65 years old (inclusive of 18 and 65 years old); 2. Patients who meet the diagnostic criteria for breast hyperplasia in Western medicine and have a Visual Analog Scale (VAS) score for breast pain of =4 points; 3. Patients who voluntarily participate in this study, provide informed consent, have good compliance, and are willing to cooperate with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Patients with other breast-related diseases such as acute mastitis benign or malignant breast tumors; 2. Patients with other diseases causing chest pain; 3. Patients with severe primary diseases of the liver kidneys or hematopoietic system; 4. Patients with biochemical indicators showing total bilirubin (TBIL) > 1.5 × upper limit of normal (ULN) alanine aminotransferase (ALT) > 1.5 × ULN or aspartate aminotransferase (AST) > 1.5 × ULN; 5. Pregnant or breastfeeding women; 6. Patients with an allergic constitution or allergies to the ingredients of the study medication; 7. Patients with a confirmed diagnosis of anxiety disorder; 8. Patients who had participated in other clinical trials within the past three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Breast pain assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploration of the pharmacological mechanisms of action (IL-6 TNF-a);Changes in breast lumps;Hormonal regulation indicators (estrogen progesterone prolactin);Anxiety and Depression Assessment Scales (PHQ-9 GAD-7 SDS SAS);Quality of Life Scale (SF-36); | — |
Countries
China
Contacts
Public ContactQianjun Chen
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed