Female breast hyperplasia with thyroid nodules
Conditions
Interventions
Test group:Take Rupisanjie Capsules 4 capsules each time 3 times a day.
Control group:Take the Rupisanjie Capsules placebo, four capsules each time, three times a day.
Sponsors
Chongqing Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: (1)Those diagnosed by investigator as having breast hyperplasia with thyroid nodules that have been present for more than 3 months; (2)Meets the diagnostic criteria for liver depression and qi stagnation syndrome; (3)Breast pain during menstruation (worst) with a VAS score of = 4 points and a cumulative pain duration of>3 days during the menstrual cycle; (4)Women between the ages of 18 and 50 years (including endpoint values) with a substantially regular menstrual cycle and menstrual period defined as a menstrual cycle of 28 ± 7 days and a menstrual period of 3 to 7 days; (5)On ultrasonography their breast nodules were graded at BI-RADS classification 2 to 3 and the maximum diameter of any 1 nodule was <1.5 cm; (6)Thyroid ultrasound TI-RADS grade 2-3 and maximum diameter <2cm; (7)Subjects volunteered to participate in the trial agreed and signed an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with thyroid nodules or breast hyperplasia showing signs of degeneration or malignant transformation such as thyroid nodules with solid hypoechoic or solid components in cystic-solid nodules being hypoechoic nodules with rich blood supply or those who meet the surgical intervention criteria. (2) Patients suffering from other thyroid diseases such as primary hyperthyroidism hypothyroidism painless thyroiditis subacute thyroiditis thyroid cancer etc. (3) Patients with other breast diseases such as acute mastitis breast tuberculosis breast cancer etc. or benign breast tumors such as fibroadenoma intraductal papilloma tumors of other origins but growing in the breast area. (4) Patients previously diagnosed with premenstrual syndrome dysfunctional uterine bleeding amenorrhea polycystic ovary syndrome menopausal syndrome hyperprolactinemia and who still need to regulate hormone levels for treatment during the current period such as those receiving exogenous estrogen therapy. (5) Patients planning to receive iodine treatment/examination or other intervention treatments for thyroid nodules during the study period. (6) Patients who have received iodine treatment/examination within 6 months; those who have received thyroid hormone medications within 3 months. (7) Patients who have used Chinese or Western medicines (including external application medications acupuncture etc.) for treating breast hyperplasia or thyroid nodules within 1 week and during the screening period or those who have used painkillers. (8) Patients with severe heart diseases severe lung diseases cerebral infarction endocrine mental tumor and other serious diseases or those with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the upper limit of normal value serum creatinine > the upper limit of normal value or those undergoing kidney dialysis treatment. (9) Pregnant and lactating women or menopausal women or women with oligomenorrhea (defined as no menstruation for = 3 months). (10) Patients with mental disorders or those who are uncooperative. (11) Patients with allergic constitution or those allergic to the components of this product. (12) Patients who are considered by the researchers as inappropriate to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum diameter of thyroid nodules (by ultrasound); | — |
Secondary
| Measure | Time frame |
|---|---|
| Size of breast nodules (the largest nodule) (by ultrasound);Chinese medicine symptom score;Number of thyroid nodules, nodule volume, Resistance Index (RI) and Pulsatility Index (PI) of blood flow;Breast mass score;Short-Form McGill Pain Questionnaire;Thyroid Cancer-specic Quality of Life; | — |
Countries
China
Contacts
Public ContactLv Gang
Chongqing Traditional Chinese Medicine Hospital
Outcome results
None listed