Dyslipidemia
Conditions
Interventions
Sponsors
Beijing Friendship Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria at the same time: 1. Male or female aged from 18 to 80 years; 2. According to the definition of dyslipidemia in Chinese guidelines for the prevention and treatment of dyslipidemia for adults (2016 Revised Edition) (dyslipidemia usually refers to elevated serum cholesterol and / or triglyceride levels, commonly known as hyperlipidemia). The protocol stipulates: total cholesterol (TC) >= 5.2 mmol / L (200 mg / dl), 9.8 mmol / L >= LDL-C >= 4.9 mmol / L. 3. According to the guidelines for the prevention and treatment of dyslipidemia in Chinese adults (revised 2016), those subjects with high risk of atherosclerotic cardiovascular disease; 4. Subjects who had not received any lipid-lowering drugs including statins before enrollment; 5. Subjects who did not use Shouhui Tongbian capsule within 3 months before enrollment; 6. The subjects who voluntarily joined the study signed the informed consent.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria were excluded: 1. Subjects with simple hypertriglyceridemia or mixed hyperlipidemia but fasting triglyceride >= 5.7mmol/l; 2. Patients with myopathy such as myalgia, myositis and rhabdomyolysis; 3. Patients who are using cyclosporine and beta drugs; 4. Patients with aspartate aminotransferase or alanine aminotransferase > 3 times of the upper limit of normal value or patients with active liver disease; 5. Patients with abnormal serum creatinine judged by researchers to have clinical significance; 6. Patients with poor control of loose stool and diarrhea; 7. Subjects with CK > 5 times of the upper limit of normal value; 8. HIV patients treated with protease inhibitors; 9. Patients with hypothyroidism; 10. Patients with renal failure secondary to rhabdomyolysis (such as sepsis, severe metabolic, endocrine and electrolyte abnormalities, or uncontrolled epilepsy); 11. Patients allergic to the drugs used in this study; 12. Patients with mental and neurological disorders who can not express their wishes correctly; 13. Pregnant women, lactating women and women of childbearing age who did not take contraceptive measures; 14. Patients currently participating in clinical trials of other drugs or medical devices; 15. Subjects considered unsuitable by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL-C; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of LDL-C reaching to the target level(<1.8mmol/L), if the baseline value of LDL-C is too high to reach the target value, the value of LDL-C should be reduced by at least 50%;Compared with baseline, the changes of blood lipids (total cholesterol, triglycerides, HDL-C, apolipoprotein A1, apolipoprotein B and lipoprotein(a);The incidence of adverse events.; | — |
Countries
China
Contacts
Public ContactWang Yongzhi
Beijing Friendship Hospital Affiliated to Capital Medical University
Outcome results
None listed