Preclinical Atherosclerosis
Conditions
Interventions
The intervention group:Lifestyle intervention + Tongmai jiangzhuo granules
The control group:Lifestyle intervention + Tongmai jiangzhuo granule simulations
Sponsors
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
35 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 35-75 years; 2. The carotid artery intima thickness>=1.1mm, and the groups were not diagnosed with atherosclerotic disease; 3. Accorded with TCM Syndrome Differentiation Standard; 4. Subjects should signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. The patients who had a clear diagnosis with atherosclerotic disease,Including coronary heart; disease, stroke, peripheral vascular disease, renal artery stenosis, etc.; 2. The patients who took statins lipid-lowering drugs within a month; 3. The patients who were familial hypercholesterolemia (TC>7.8mmol/l, LDL-C>=5.0mmol/l); 4. The patients who had a history of carotid surgery; 5. The patients who with the severe high blood pressure, and the poor blood pressure control (>=160/90mmHg); 6. The patients who with heart failure and severe heart rhythm disorders (sustained rapid atrial fibrillation and flutter, frequent premature ventricular beats, ventricular tachycardia, more than 2 degrees of atrioventricular block); 7. The patients who with serious primary diseases such as liver kidney, hematopoietic system diseases; The patients who were confirmed or suspected liver and kidney dysfunction (ALT, AST more than 2 times higher than normal limit, serum creatinine higher than 176umol/l) or malignant tumor; The patient with a variety of reasons of myopathy or the serum creatine phosphokinase more than 2 times higher than normal limit; 8. The patients with intellective or mental or conscious disorders; 9. The patients with gastrointestinal diseases or gastrointestinal surgery history which might affect drug absorption; 10. The patients who were vegetarians; 11. The patients who were hard-drinker or drug addict; 12. The patients who were pregnancy or lactation women; 13. The patients who were sensitive to traditional Chinese medicine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| intima-media thickness (IMT); | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM symptom score;C-reactive protein;Lipid profile (TC, TG, LDL-C, HDL-C, APO-A1, APO-B);Pulse wave velocity, Ankle brachial index (PWV, ABI);Occurrence rate of end point events; | — |
Countries
China
Contacts
Public ContactFengrong Wang
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Outcome results
None listed