Type 2 diabetes mellitus combined with hyperlipidemia and carotid atherosclerotic plaque
Conditions
Interventions
Yiqi Tongmai Jiangzhi Formula intervention group:Oral administration of Yiqi Tongmai Jiangzhi Formula, one dose per day, a total of 2 sachets, 1 sachet each time, 1 hour after meals in the morning and
Placebo group:Oral placebo, 2 sachets of 2 sachets daily, 1 sachet each time, 1 hour after meals in the morning and evening, for 12 weeks.
Sponsors
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Serum LDL cholesterol = 4.1 mmol/L; (2) Fulfillment of diagnostic criteria for type 2 diabetes mellitus; (3) Meet the diagnostic criteria for carotid atherosclerotic plaque; (4) Age between 30-75 years old gender is not limited; (5) Comply with the diagnostic criteria of phlegm and stasis in traditional Chinese medicine; (6) Patients volunteered to be tested and signed an informed consent form.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following will be excluded from this study: (1) Hepatic and renal insufficiency (ALT or AST higher than 1.5 times ULN Cr and BUN higher than ULN); (2) Subjects with severe hematopoietic disorders malignant tumors heart failure and other major diseases; (3) Subjects with platelet lowering and coagulation disorders and those with a history of cerebral hemorrhage within the last year or combined organ bleeding; (4) Women with excessive menstrual flow prolonged menstrual period or history of dysfunctional uterine bleeding within the past year; (5) Women who are pregnant breastfeeding or planning to become pregnant during the trial; (6) Those who have participated or are participating in other clinical studies within the last three months; (7) Persons with suspected or definite allergy to the study drug; (8) Other patients who in the opinion of the investigator should not be enrolled in a clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum LDL cholesterol; | — |
Secondary
| Measure | Time frame |
|---|---|
| transcriptome testing;Serum HDL cholesterol level;Quality of life score (SF36);glycosylated hemoglobin;Metabolomics testing;resistance index;Carotid artery intima-media thickness;Chinese Medicine Criteria Score;Serum total cholesterol level;fasting blood sugar;Inflammatory factor IL-6 levels;Proteomics testing;hs-CRP;Plaque length × thickness value (longitudinal section);CPT1A gene expression;Serum triglyceride levels;pulsatility index;HIF-1 gene expression; | — |
Countries
China
Contacts
Public ContactYang Qiaoning
Xiyuan Hospital China Academy of Chinese Medical Sciences
Outcome results
None listed