T2DM
Conditions
Interventions
treatment group:SQHY formula
control group:placebo
Sponsors
Hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Patients diagnosed with type 2 diabetes mellitus. (2) Patients diagnosed with coronary atherosclerotic heart disease combined with peripheral arterial stenosis (3) Patients diagnosed with diabetic macroangiopathy with TCM qi and yin deficiency with evidence of stasis. (4) Age = 50 years (5) Patients who voluntarily participated in this study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Those with indications for coronary and peripheral artery revascularization at the time of screening. (2) Those with a definite cardiovascular event within 3 months of enrollment, such as acute ACS, myocardial infarction, cerebral infarction, or hospitalization for heart failure. (3) Those with definite foot ulcers within 3 months prior to enrollment. (4) Untreated hypertensive disease, defined as systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg at enrollment. (5) Those with severe hepatic impairment (ALT or AST or ALP greater than 1.5 times the upper limit of normal) or renal impairment (Cr greater than the upper limit of normal or eGFR = 45 mL/min/1.73 m2) at screening. (6) Those with malignant tumors or severe psychosomatic diseases. (7) Those with other serious medical conditions and a life expectancy of less than 2 years. (8) Pregnant and lactating women. (9) Those who have received or are using systemic hormones (including glucocorticoids), immunosuppressive drugs, or cytotoxic therapy within 3 months prior to screening (except for topical systemic steroids for no more than 7 days and those using emergency contraception). (10) Known hypersensitivity to Ginseng and Astragalus formula or its components in preparations. (11) Participation in any other clinical trial of a drug or device within 30 days prior to screening. (12) In the opinion of the investigator, the patient is noncompliant and unable to complete the study as required or is otherwise unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major adverse cardiovascular events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Non-fatal myocardial infarction;Non-fatal stroke;Diabetic foot ulcers;Advances in diabetic lower extremity arterial disease; Renal-related adverse events;Emergency visits for cardiovascular disease;LVEF;SV;Ultrasound of peripheral arteries;ACR;eGFR;Fundus photography;FPG;HbA1c;TC;TG;LDL-C;HDL-C;TCM syndrome;6 minutes walking distance;The Kansas City Cardiomyopathy Questionnaire (KCCQ);DMQLS; | — |
Countries
China
Contacts
Public ContactXie Chunguang
Hospital of Chengdu University of Traditional Chinese Medicine
Outcome results
None listed