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A Study on Postmarketing Xuezhikang Capsule for Treating Dyslipidemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02057302
Recruitment Status : Completed
First Posted : February 7, 2014
Last Update Posted : February 7, 2014
Sponsor:
Information provided by (Responsible Party):
Xing Liao, China Academy of Chinese Medical Sciences

Tracking Information
First Submitted Date  ICMJE January 28, 2014
First Posted Date  ICMJE February 7, 2014
Last Update Posted Date February 7, 2014
Study Start Date  ICMJE March 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 6, 2014)
safety outcomes including vital signs and laboratory tests [ Time Frame: to detect the change from baseline to 8th week ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study on Postmarketing Xuezhikang Capsule for Treating Dyslipidemia
Official Title  ICMJE A Multicenter, Pragmatic Randomized, Double-blind, Placebo-controlled Trial of Xuezhikang Capsule for Treating Dyslipidemia: a Postmarketing Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Dyslipidemia
Intervention  ICMJE Drug: Xuezhikang capsule
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Xuezhikang capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2014)
2400
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02057302
Other Study ID Numbers  ICMJE 2008ZX09202-007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xing Liao, China Academy of Chinese Medical Sciences
Study Sponsor  ICMJE China Academy of Chinese Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account China Academy of Chinese Medical Sciences
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP