Hyperplasia of Mammary Gland (HMG)
Conditions
Interventions
Chinese herbal formula RCA group.:All subjects receive RCA treatment: once daily, administered in two divided doses in the morning and evening, orally, for 14 consecutive days, followed by a 14-day ob
Sponsors
Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital Hainan Branch Hospital (Hainan Boao Research-Oriented Hospital)
Eligibility
Sex/Gender
Female
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for mastopathy; (2) Has been diagnosed and prescribed at the Traditional Chinese Medicine Internal Medicine Clinic of Ruijin Hainan Hospital; (3) Has a history of breast pain before menstruation, with a disease duration of =3 months, and a premenstrual breast distension pain VAS score of =3 points; (4) Is aged between 18-55 years old, with a basically regular menstrual cycle and period; (5) Is able to cooperate with clinical follow-up and provide complete medical history and imaging data; (6) Has given informed consent and voluntarily participates.
Exclusion criteria
Exclusion criteria: (1) Women who are pregnant, preparing for pregnancy, breastfeeding, experiencing severe menstrual cycle disorders, or suffering from functional uterine bleeding; (2) Patients with chest pain caused by muscle pain, bone pain, nerve pain, or referred pain from visceral organs; (3) Individuals with concurrent mastitis, breast tumors, or other breast-related diseases; (4) Participants who are lost to follow-up or from whom follow-up efficacy data cannot be obtained; (5) Individuals with a history of allergies or known hypersensitivity to any components of the drug's prescription; (6) Patients with severe liver or kidney dysfunction; (7) Individuals with concurrent cardiovascular, cerebrovascular, hematological diseases, severe psychological disorders, major mental or cognitive impairments; (8) Participants who have taken Chinese medicine, Western medicine, contraceptives, or other sex hormone-related drugs for the treatment of breast hyperplasia within the past 15 days, or have concurrent conditions requiring sex hormone therapy; (9) Individuals with a history of long-term alcohol abuse or substance misuse; (10) Patients deemed unsuitable for this clinical study by the physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Breast pain VAS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dysmenorrhea VAS Score;Breast lump changes;Traditional Chinese Medicine Syndrome Scoring;BI-RADS Classification;Hamilton Anxiety Rating Scale (HAM-A);Adverse Event Incidence Rate; | — |
Countries
China
Contacts
Public ContactLiu Xiaoyu
Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital Hainan Branch Hospital (Hainan Boao Research-Oriented Hospital)
Outcome results
None listed