A Study on Postmarketing Xuezhikang Capsule for Treating Dyslipidemia

February 6, 2014 updated by: Xing Liao, China Academy of Chinese Medical Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2400

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Group B
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
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
safety outcomes including vital signs and laboratory tests
Time Frame: to detect the change from baseline to 8th week
to detect the change from baseline to 8th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Academy of Chinese Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

February 6, 2014

First Posted (ESTIMATE)

February 7, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 7, 2014

Last Update Submitted That Met QC Criteria

February 6, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008ZX09202-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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