A Study on Postmarketing Xuezhikang Capsule for Treating Dyslipidemia

China Academy of Chinese Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Dyslipidemia

Treatments: Drug: Xuezhikang capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT02057302

2008ZX09202-007

Details and patient eligibility

About

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.

Enrollment: 2,400 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,400 participants in 2 patient groups, including a placebo group

Group B

Placebo Comparator group

Description:

There are 538 patients recruited in this group. Patients in this group will take 2 capsules of placebo every time, twice every day, respectively after breakfast and supper.

Group A

Experimental group

Description:

There are 1614 patients recruited in this group. Patients in this group will take 2 capsules of Xuezhikang every time, twice every day, respectively after breakfast and supper.

Treatment:

Drug: Xuezhikang capsule