A Study on Postmarketing Xuezhikang Capsule for Treating Dyslipidemia

Study Overview
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Brief Summary
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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.

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

Conditions
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Dyslipidemia

Intervention / Treatment
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* Drug: Xuezhikang capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 years to 75 years Patients with Dyslipidemia should be diagnosed according to standard western medicine diagnosis criteria TCM syndrome of patients with dyslipidemia should be diagnosed according to standard TCM syndrome diagnosis criteria Patients who have taken lipid lowering drugs should stop taking for at least two weeks before taking part in this study Patients agree to participate in this study and signed the informed consent form Exclusion Criteria: Pregnant (positive pregnancy test within 7 days of starting treatment), or lactating women. Patients with Homozygous Familial Hypercholesterolemia Patients with known allergy to Chinese medicine or any other drug Patients with acute myocardial infarction, cerebrovascular accident , severe trauma , major surgery and cancer in half a year. AST or ALT level increases at least twice the upper limits of normal in patients Patients who are taking part in other clinical trials that will influence the results of this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group B<br>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. | |
| Experimental: Group A<br>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. | Drug: Xuezhikang capsule<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood samples were drawn were detected,including TC,TG,LDL-C and HDL-C |  | the detect the change from baseline to the 8th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Traditional Chinese medicine syndrome scores (TCM-SS) and single TCM symptom |  | to detect the change at baseline, 2nd week, 4th week, 6th week, and 8th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xuezhikang Dyslipidemia chinese medicine RCT