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

Beijing Friendship Hospital Affiliated to Capital Medical University0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

Beijing Friendship Hospital Affiliated to Capital Medical University