A Study on Postmarketing Xuezhikang Capsule for Treating Dyslipidemia

Phase 4

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: Xuezhikang capsule

• Registration Number: NCT02057302
• Lead Sponsor: China Academy of Chinese Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2012-12
• Study First Submitted: 2014-01-28
• Status Verified: 2014-02
• Study First Submitted QC: 2014-02-06
• Last Update Submitted: 2014-02-06
• Study First Posted: 2014-02-07
• Last Update Posted: 2014-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Xuezhikang capsule	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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