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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

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.


Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: Xuezhikang capsule Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Multicenter, Pragmatic Randomized, Double-blind, Placebo-controlled Trial of Xuezhikang Capsule for Treating Dyslipidemia: a Postmarketing Study
Study Start Date : March 2010
Actual Primary Completion Date : December 2012

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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Other Outcome Measures:
  1. safety outcomes including vital signs and laboratory tests [ Time Frame: to detect the change from baseline to 8th week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Responsible Party: Xing Liao, Professor, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT02057302    
Other Study ID Numbers: 2008ZX09202-007
First Posted: February 7, 2014    Key Record Dates
Last Update Posted: February 7, 2014
Last Verified: February 2014
Keywords provided by Xing Liao, China Academy of Chinese Medical Sciences:
Xuezhikang Dyslipidemia chinese medicine RCT
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases