Dyslipidemia
Conditions
Keywords
Xuezhikang Dyslipidemia chinese medicine RCT
Brief summary
Dyslipidemia contributes greatly to the formation and progression of atherosclerosis (AS), which plays a dominant role in leading to CHD. Xuezhikang is a partially purified extract of fermented red yeast rice (Monascus purpureus). It is composed of 13 kinds of natural statins, unsaturated fatty acids, ergosterol,amino acids, flavonoids, alkaloid, trace element, and so forth. Xuezhikang has been recommended in a guideline for China adult dyslipidemia prevention. This study aims to evaluate the benefit and side effect of Xuezhikang, a potential alternative drug of statins, for patients with dyslipidemia, and thus provide further evidence for clinical application.
Interventions
Sponsors
China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18 years to 75 years 2. Patients with Dyslipidemia should be diagnosed according to standard western medicine diagnosis criteria 3. TCM syndrome of patients with dyslipidemia should be diagnosed according to standard TCM syndrome diagnosis criteria 4. Patients who have taken lipid lowering drugs should stop taking for at least two weeks before taking part in this study 5. Patients agree to participate in this study and signed the informed consent form
Exclusion criteria
1. Pregnant (positive pregnancy test within 7 days of starting treatment), or lactating women. 2. Patients with Homozygous Familial Hypercholesterolemia 3. Patients with known allergy to Chinese medicine or any other drug 4. Patients with acute myocardial infarction, cerebrovascular accident , severe trauma , major surgery and cancer in half a year. 5. AST or ALT level increases at least twice the upper limits of normal in patients 6. Patients who are taking part in other clinical trials that will influence the results of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood samples were drawn were detected,including TC,TG,LDL-C and HDL-C | the detect the change from baseline to the 8th week |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese medicine syndrome scores (TCM-SS) and single TCM symptom | to detect the change at baseline, 2nd week, 4th week, 6th week, and 8th week |
Other
| Measure | Time frame |
|---|---|
| safety outcomes including vital signs and laboratory tests | to detect the change from baseline to 8th week |
Outcome results
None listed