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A Study on Postmarketing Xuezhikang Capsule for Treating Dyslipidemia

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Xuezhikang capsule
Sponsored by
China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia focused on measuring Xuezhikang Dyslipidemia chinese medicine RCT

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Group B

    Group A

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Blood samples were drawn were detected,including TC,TG,LDL-C and HDL-C

    Secondary Outcome Measures

    Traditional Chinese medicine syndrome scores (TCM-SS) and single TCM symptom

    Full Information

    First Posted
    January 28, 2014
    Last Updated
    February 6, 2014
    Sponsor
    China Academy of Chinese Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02057302
    Brief Title
    A Study on Postmarketing Xuezhikang Capsule for Treating Dyslipidemia
    Official Title
    A Multicenter, Pragmatic Randomized, Double-blind, Placebo-controlled Trial of Xuezhikang Capsule for Treating Dyslipidemia: a Postmarketing Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2010 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    China Academy of Chinese Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dyslipidemia
    Keywords
    Xuezhikang Dyslipidemia chinese medicine RCT

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    2400 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group B
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Description
    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 Type
    Drug
    Intervention Name(s)
    Xuezhikang capsule
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    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 Pre-specified Outcome Measures:
    Title
    safety outcomes including vital signs and laboratory tests
    Time Frame
    to detect the change from baseline to 8th week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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    A Study on Postmarketing Xuezhikang Capsule for Treating Dyslipidemia

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