Malignant tumor of breast
Conditions
Interventions
The group treated with Chinese medicine: "Yiqi Huoxue" formula+health education
placebo group:One-tenth the dose of "Yiqi Huoxue" formula+health education
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 40 to 75 years eligible for postmenopausal status: (a) have undergone bilateral oophorectomy; (b) are 60 years or older; (c) persons younger than 60 years of age who have not been medically castrated (e.g. GnRHa) and whose follicle-stimulating hormone and estradiol levels are in the postmenopausal range; 2. Postoperative pathological identification of breast cancer as non-metastatic estrogen receptor-positive and/or progesterone receptor-positive early breast cancer stable treatment with aromatase inhibitors =1 year no concurrent radiotherapy chemotherapy and other treatments at this stage; 3. Fasting blood sampling meets the diagnostic criteria for dyslipidemia; 4. Meet the diagnostic criteria of Qi deficiency and blood stasis syndrome in TCM; 5. Patients voluntarily participated in this study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Secondary hyperlipidemia and homozygous hypercholesterolemia caused by nephrotic syndrome hypothyroidism gout liver and gallbladder diseases diabetes etc.; Hyperlipidemia caused by drugs (phenothiazines beta-blockers corticosteroids and certain contraceptives etc.); 2.Lipid-lowering drugs were administered within 4 weeks prior to enrollment. Such as statins cholesterol absorption inhibitors probucol cholic acid chelating agents and other major cholesterol-lowering lipid-regulating drugs (such as lipbitacin docoicosanol etc.) bate niacin and high-purity fish oil preparations microsomal TG Transfer protein inhibitor apolipoprotein B100 synthesis inhibitor preprotein converting enzyme subtilysin 9 (PCSK9) inhibitor Chinese medicine and Chinese patent medicine with lipid-lowering effect etc. 3.Patients who had acute myocardial infarction cerebrovascular accident severe trauma coronary surgery or other major surgery within 6 months before enrollment and needed to take lipid-lowering drugs for a long time; 4.Patients with uncontrolled hypertension (sitting diastolic blood pressure =110 mmHg or systolic blood pressure =180mmHg) or who are taking antihypertensive drugs (diuretics beta-blockers) that affect blood lipids; 5.Diabetes mellitus with any of the following conditions: type 1 diabetes mellitus history of diabetic ketoacidosis uncontrolled type 2 diabetes mellitus (defined as HbA1c>7%); 6.Thyroid dysfunction (such as hyperthyroidism hypothyroidism etc.); 7.Drug or alcohol abusers [defined as those who consumed an average of 14 or more units of alcohol per week (1 unit = 350 mL beer 45 mL liquor or 150 mL wine) during the 3 months prior to enrollment]; 8.Abnormal liver and kidney function glutamic pyruvic transaminase and/or glutamic oxalacetic transaminase = 1.5 times the upper limit of normal or creatinine exceeding the upper limit of normal; 9.Stratified according to ASCVD as very high risk and super high risk; 10.Complicated with any other malignant tumor; 11.Patients with distant metastatic breast cancer; 12.Allergic to the investigational drug or its excipients; 13.People suffering from mental illness language impairment or other reasons unable to cooperate with the study or refuse to have their blood drawn; 14.Participants in other clinical trials during the same period; 15.Those who are pregnant or breastfeeding (excluded by blood HCG).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The control rate of LDL-C; | — |
Secondary
| Measure | Time frame |
|---|---|
| APOC3;Changes of immune cells;Body fat;Lipid metabolites;Liver Fatty Content;Waist-to-hip ratio;Body mass index;carotid intima-media thickness;Visceral fat index;Changes of blood lipid level;The percentage of body fat;Subcutaneous fat rate; | — |
Countries
China
Contacts
Public ContactJiang Ke
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine
Outcome results
None listed