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NCT Number: NCT02057302

A Study on Postmarketing Xuezhikang Capsule for Treating Dyslipidemia

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.

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xuezhikang capsule

Drug

Primary outcomes

  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 outcomes

  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 outcomes

  1. safety outcomes including vital signs and laboratory tests

    Time frame: to detect the change from baseline to 8th week

Sponsors and collaborators

Lead sponsor

China Academy of Chinese Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
First posted
Feb 7, 2014
Registry last updated
Feb 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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