Atherosclerosis
Conditions
Sponsors
Affiliated Hospital of Shanxi University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1)18-65 years old (including boundary age), male or female. (2)TCM syndrome differentiation is intermingled phlegm-blood stasis syndrome. (3)Meet the diagnostic criteria of dyslipemia. (4)Ultrasound shows carotid intima-media thickness = 0.9mm or the presence of atherosclerotic plaque; or coronary angiography or coronary artery CTA examination shows atherosclerotic plaque or lumen stenosis is 30% ~50%. (5)patients did not take or regularly take lipid-lowering drugs in the past one month. (6)The basic principle of freely given informed consent for all subjects.
Exclusion criteria
Exclusion criteria: (1)Those with poor control of blood pressure and sugar, with glycosylated hemoglobin > 6.5% and blood pressure >160/100mmHg at the end of leading-in period. (2)Obvious liver and kidney function damage, with ALT and AST are 1.5 times higher than the upper limit of normal value,, and Cr and BUN are higher than the upper limit of normal value. (3)Combined with severe systemic diseases such as respiratory system, nervous system, immune system or et al, malignant tumor patients or patients with severe trauma, infection, etc. (4)Allergic constitution or allergic to the known components of the experimental drugs. (5)Women of childbearing age who are pregnant, lactating, or have a pregnancy intention or positive pregnant test (urine HCG), or those who cannot take effective contraception during the study (effective contraception includes sterilization, IDU, oral contraceptives or the diaphragm method by the local law). (6)Patients who have participated in other drug or medical devices clinical trails in the past 3 months. (7)Mental or neurological diseases who failure to correctly express wishes or communicate. (8)Alcoholics, drug abusers and addicts.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum lipid level;Evaluation of atherosclerotic plaque(IMT or lumen stenosis); | — |
Secondary
| Measure | Time frame |
|---|---|
| serum lipid level of 8 weeks ;Evaluation of atherosclerotic plaque of 8weeks;ASCVD of 12 weeks;TCM syndrome score; | — |
Countries
The people's republic of China
Contacts
Public ContactZhigeng Hu/ Jincheng Chen
Shanxi University of Chinese Medicine
Outcome results
None listed