Atherosclerosis
Conditions
Interventions
Chinese medicine:cangpu decoction
control group:simvastatin capsules
Sponsors
Tongji University
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The inclusion criteria of diet intraduction stage: (1) To be attend the study voluntarily and signed the informed consent; (2) Both male and female, aged between 40 and 75 years; the female should be after menopause; (3) Carotid artery intima-media thickness (IMT) 1mm with plaque, diagnosed by vascular ultrasound B; (4) To be with TCM symptoms of chest distress, chest pain, palpitations, shortness of breath, dizziness, tinnitus, insomnia, forgetfulness, hand and foot numbness, spontaneous sweating, shortness of breath; (5) Fast blood LDL-C>=140mg/dl (3.64mmol/L), TG=140mg/dl(3.64mmol/L), TG<=500mg/dl (5.6mmol/L); (2) Carotid artery intima-media thickness (IMT) 1mm with plaque, diagnosed by vascular ultrasound B; (3) To be with TCM symptoms of chest distress, chest pain, palpitations, shortness of breath, dizziness, tinnitus, insomnia, forgetfulness, hand and foot numbness, spontaneous sweating, shortness of breath; (4) To be confirmed that the participant has been compliance the diet guideline.
Exclusion criteria
Exclusion criteria: 1. The exclusion criteria of diet introduction stage: person to be found with following condition at the first site visit will be excluded: (1) Acute coronary syndrome and cerebral vascular accident in the past three months; (3) Congestive heart failure symptom grade III or above; (4) Uncontrolled hypertention (sitting diastolic blood pressure>110mmHg or systolic pressure>180mmHg; (5) Nephrotic syndrome needs to treated by dialysis treatment or with renal failur history; (6) The blood glucose level not be controlled satisfied or unstable type II diabetes mellitus, the fast surgar level>200mg/dl (11.1mmol/L); (7) Unclear reason of CK concentration higher than normal level 3 folders (not caused by recent trauma, intramuscular injection, strenuous exercise); (8) Untreated thyroid diseases; (9) Allergic history for statines or severe adverse reaction resulted in taking statines; (10) To be attended other drug clinical study in past three monthes; (11) Medicine caused hyperlipidemia or homozygous familial hypercholesterolemia; (12) To be used Probucol in past one year; or need to use Cyclosporin; (13) To be with tumour or tumour history; (14) To be complicated with mental diseases or alcohol or drug dependence; (15) Other stituation to be considered should be excluded. 2. Exclusion criteria in the double-blinding treatment stage: person with following diseases will be excluded: (1) Acute coronary syndrome and cerebral vascular accident in the past four months; (2) Current with congestive heart failure symptom grade III or above; (3) Uncontrolled hypertention (sitting diastolic blood pressure>110mmHg or systolic pressure>180mmHg; (4) Nephrotic syndrome needs to be treated by dialysis or with renal failur history; (5) The blood glucose level not be controlled satisfied or unstable type II diabetes mellitus, the fast surgar level>200mg/dl (11.1mmol/L); (6) Unclear reason of CK concentration higher than normal level 3 folders (not caused by recent trauma, intramuscular injection, strenuous exercise); (7) Untreated thyroid diseases; (8) Allergic history for statines or severe adverse reaction resulted in taking statines; (9) To be atteded other drug study in past four months; (10) Is treating by P450 metablic drugs or other lowing lipid drugs; (11) Medicine caused hyperlipidemia or homozygous familial hypercholesterolemia; (12) To be used Probucol in past one year; or need to use Cyclosporin; (13) Tumour patient or tumour history; (14) To be complicated with mental diseases or alcohol or drug dependence; (15) Impaired renal function, blood Cr concentration>220umol/L(2.5mg/dl); (16) To be with action liver disease or hipatitis history, or ALT and/or AST>1.5 folders than normal value; (17) Used Cholesterol lowering drugs or lipid-lowering dietary supplements or food additives after the first site visit (week 4); (18) Other situation to be considered should be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IMT value;The grade of atherosclerotic plaqu ; | — |
Secondary
| Measure | Time frame |
|---|---|
| The decrease percentage of LDL-C;The standardized rate of LDL-C;The decrease percentage of TC;The decrease percentage of TG;The increase percentage of HDL-C;The value of Pulse Wave Velocity (PWV);The value of arterial stiffness index (ASI);The value of ß;The score of traditional Chinese pattern medicine; | — |
Contacts
Public ContactYandexin, Chen Yihan
Outcome results
None listed