Hyperplasic disease of breast (pattern of disharmony of thoroughfare and conception vessels).
Conditions
Interventions
Group A:External use by sanjiezhitong plaster
Sponsors
Ministry of Science and Technology of China
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Conform to the diagnosis standard of hyperplasic disease of breast; 2. Conform to the diagnosis standard of TCM syndrome differentiation syndrome of disharmony of thoroughfare and conception vessels and the menstrual cycle relative stability(28+/-3days); 3. There are periodic breast pain before menses and the course of disease over 3 months; 4. There are moderate and severe breast pain with the VAS appraises over 40mm and ads up over 3 days; 5. Premenopausal women during the age of 18~50 (includes 18,50); 6. Not any Chinese medicine or western medicine are used for the treatment of HDB or relieving the breast pain during the last three months and not any hormone medicine or oral contraceptives or hormone replacement therapy medicine are used during the past half year; 7. When do the breast clinic physical examination, there are at least one tangible node or the pathetical change of hyperplasia of mammary glands on each brest; 8. There is any thyroid disease before, and the function of thyroid is normal, and the function of heart lever kidney is all normal mainly; 9. The skin of the breast is complete and there is no broken or ulcer or dermatitis; 10. Receipt the clinical trial voluntarily and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Conform to the diagnosis standard of Hyperplasic disease of breast but without the symptom of periodical breast pain; 2. Do not have the syndrome of disharmony of thoroughfare and conception vessels or have but the menostaxis and the period over 7 days or the menopause and menstrual cycle serious irregular; 3. Merge breast cancer or mastitis or other breast disease with the indication of surgical operation; 4. Merge heart cerebrovascular disease, serious primary disease of lever kidney and hemopoietic system or digestive tract ulcer disease or other serious disease (such as tumor or AIDS) that effect survival, or disable in mental or law; 5. With abnormal lab index: (1) ALT, AST, BUN over 20% of superior limit of normal; (2) with abnormal electrocardiogram that have clinical significance; (3) with other abnormal lab index that have clinical significance; 6. Who once have breast plastic surgery; 7. Who had her ovary cut off (part or whole); 8. Pain form anterior or lateral breast that caused by other disease; 9. Women during the time of pregnancy or breast-feed or have the plan to pregnancy in three months; 10. Allergy hereditary people or have already now allergy to the composition of the prescription; 11. Judging from the researcher, with the possibility of lower enrollment or have other disease make the enroll of the experience complicity, such as, the woke place often change may lead to fail to pay a return visit, and with mental or behavior obstacle that fail to have full know the fact of the case and agreement it; 12. Patient who take part in other clinical trial in the nearest month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current pain intensity grading method;Visual analogue scales(VAS);McGill pain questionnaires; | — |
Secondary
| Measure | Time frame |
|---|---|
| High frequency color spectrum le B super breast exams;Estrogen level detection;The evaluation index of clinical curative effect of Chinese medicine; | — |
Countries
China
Contacts
Public ContactSheng Liu
Outcome results
None listed