hyperplasia of mammary glands
Conditions
Interventions
test team:Danlu capsules
control group:Danlu capsule simulator
Sponsors
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: (1) Female patients aged 18 to 50 years (including boundary value); (2) Those who meet the diagnostic criteria of breast hyperplasia in western medicine and have a course of more than 3 months; (3) Breast color Doppler ultrasound BI-RADS grade = 3; (4) Screening period breast pain VAS score =45mm and palpation of target mass; (5) During the introduction period the mean VAS score of breast pain within days was greater than or equal to 45mm and there were still target masses on palpation; (6) Voluntarily participate in the trial and sign the informed consent form with informed consent.
Exclusion criteria
Exclusion criteria: (1) Those who have other breast diseases or breast pain caused by other reasons such as mastitis and breast cancer; (2) Patients with severe cardiovascular and cerebrovascular diseases liver kidney malignant tumors and blood system diseases; (3) Patients with mental disorders (such as anxiety disorder) and (or) are taking relevant psychotropic drugs (such as benzodiazepines selective serotonin reuptake inhibitors and serotonin and norepinephrine reuptake inhibitors); (4) those who have been diagnosed with dysfunctional uterine bleeding amenorrhea polycystic ovary syndrome menopausal syndrome hyperprolactinemia hypercortisolism and other diseases and still need to regulate hormone levels for treatment; (5) Abnormal liver function (ALT or AST or ALP or GGT>1.2 times the upper limit of normal value) or renal function (serum Cr or BUN or Urea>1.2 times the upper limit of normal value) and the investigator considers clinically significant and unsuitable for clinical trial; (6) Women in pregnancy lactation or menopause or those who have plans to become pregnant within the last 6 months; (7) Those who have used Chinese and Western medicines or other therapies (including topical drugs acupuncture etc.) to treat fibrocystic breast disease or relieve breast pain within 28 days before screening and during the introduction period or those who have used contraceptives and sex hormones within half a year; (8) severe menstrual cycle and/or period disorder (menstrual cycle>35 days or 7 days); (9) Those with allergic constitution or known allergy to the components of the prescription of the test drug; (10) Suspected or confirmed history of alcohol and drug abuse; (11) Patients who have participated in clinical trials and used trial drugs within 28 days prior to screening; (12) Failure to use a physically approved method of contraception; (13) Other lesions or conditions that reduce the likelihood of enrollment or complicate the trial such as frequent changes in the working environment that can lead to loss of follow-up and those who cannot give informed consent due to mental and behavioral disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of breast pain relief; | — |
Secondary
| Measure | Time frame |
|---|---|
| EQ-5D-5L score change value;Evaluation of dysmenorrhea symptoms in patients with dysmenorrhea;Change value of syndrome score in Traditional Chinese medicine;Evaluation of breast pain;Regional integral change value of breast hyperplasia;McGill Change in pain scale score;The hardness value of breast mass;Pain-related indicators (ß-EP SP);Value of range change in breast hyperplasia; | — |
Countries
china
Contacts
Public ContactSheng Liu
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Outcome results
None listed