A Study on Postmarketing Xuezhikang Capsule for Treating Dyslipidemia

A Multicenter, Pragmatic Randomized, Double-blind, Placebo-controlled Trial of Xuezhikang Capsule for Treating Dyslipidemia: a Postmarketing Study

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.

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