Efficacy and safety of rosuvastatin combined with Shouhui Tongbian capsule in the treatment of dyslipidemia: a prospective, single-center, open, randomized controlled study

Phase 4

Recruiting

Conditions: Dyslipidemia

Registration Number: ITMCTR2100004388

Lead Sponsor: Beijing Friendship Hospital Affiliated to Capital Medical University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: Not specified

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

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.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DL-C;

Secondary Outcome Measures

Name	Time	Method
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.;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%;