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Effect of Chinese Traditional Medicine for Post Revascularization Treatment of Coronary Artery Disease

Primary Purpose

Percutaneous Coronary Artery Intervention, Coronary Artery Bypass Graft, Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cipher prescription 1
cipher prescription 2
Sponsored by
Guangzhou University of Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Percutaneous Coronary Artery Intervention focused on measuring percutaneous coronary artery intervention, coronary artery bypass graft, acute coronary syndrome

Eligibility Criteria

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

Inclusion Criteria:

  • age40～75
  • angina or CAD patient
  • deficiency of heart-QI and blockage of phlegm and blood stasis in chinese medicine
  • 1 week after operation，or 1week after drainage tube extraction for CABG
  • sign a informed consent

Exclusion Criteria:

  • severe cardia failure
  • severe renal inadequacy
  • complicating with malignant tumor,reactive alimentary tract hemorrhage and haematological systemic disorder etc.
  • psychotic
  • pregnant,lactation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    managed group

    control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    dead

    Secondary Outcome Measures

    cardiovascular event

    Full Information

    First Posted
    August 24, 2009
    Last Updated
    August 24, 2009
    Sponsor
    Guangzhou University of Chinese Medicine
    Collaborators
    Xiyuan Hospital of China Academy of Chinese Medical Sciences, Guangdong Provincial People's Hospital, China-Japan Friendship Hospital, Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Teaching Hospital of Nanjin University of Traditional Chinese Medicine, Second People's Hospital, Fujian Province, Liaoning University of Traditional Chinese Medicine, Guangzhou Overseas Chinese Hospital, Beijing Tongren Hospital, Shanghai 10th People's Hospital, PLA.The Military General Hospital of Beijing, The Sixth Affliated Hospital of Jinan University, Beijing Anzhen Hospital, Gansu Provincial Hospital, Shaanxi Provincial People's Hospital, First Affiliated Hospital, Sun Yat-Sen University, The Fifth Affliated Hospital of Guangxi Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00965471
    Brief Title
    Effect of Chinese Traditional Medicine for Post Revascularization Treatment of Coronary Artery Disease
    Official Title
    Effect of Chinese Traditional Medicine for Post Revascularization Treatment of Coronary Artery Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2006 (undefined)
    Primary Completion Date
    October 2008 (Actual)
    Study Completion Date
    June 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Guangzhou University of Chinese Medicine
    Collaborators
    Xiyuan Hospital of China Academy of Chinese Medical Sciences, Guangdong Provincial People's Hospital, China-Japan Friendship Hospital, Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Teaching Hospital of Nanjin University of Traditional Chinese Medicine, Second People's Hospital, Fujian Province, Liaoning University of Traditional Chinese Medicine, Guangzhou Overseas Chinese Hospital, Beijing Tongren Hospital, Shanghai 10th People's Hospital, PLA.The Military General Hospital of Beijing, The Sixth Affliated Hospital of Jinan University, Beijing Anzhen Hospital, Gansu Provincial Hospital, Shaanxi Provincial People's Hospital, First Affiliated Hospital, Sun Yat-Sen University, The Fifth Affliated Hospital of Guangxi Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to built the standard of Chinese Traditional Medicine test for Post percutaneous coronary artery intervention and coronary artery bypass graft，also for acute coronary syndrome，according to the multi-site、random large sample test.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Percutaneous Coronary Artery Intervention, Coronary Artery Bypass Graft, Acute Coronary Syndrome
    Keywords
    percutaneous coronary artery intervention, coronary artery bypass graft, acute coronary syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    940 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    managed group
    Arm Type
    Experimental
    Arm Title
    control group
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    cipher prescription 1
    Intervention Description
    Drug granules include ginseng,RADIX NOTOGINSENG,prepared RHIZOMA PINELLIAE with alumen radix glyrrhigae calcaren once daily for 180 days
    Intervention Type
    Drug
    Intervention Name(s)
    cipher prescription 2
    Intervention Description
    Placebo include amidon、bitter principles and diluents bases once daily for 180 days
    Primary Outcome Measure Information:
    Title
    dead
    Time Frame
    180±3days
    Secondary Outcome Measure Information:
    Title
    cardiovascular event
    Time Frame
    180±3days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age40～75 angina or CAD patient deficiency of heart-QI and blockage of phlegm and blood stasis in chinese medicine 1 week after operation，or 1week after drainage tube extraction for CABG sign a informed consent Exclusion Criteria: severe cardia failure severe renal inadequacy complicating with malignant tumor,reactive alimentary tract hemorrhage and haematological systemic disorder etc. psychotic pregnant,lactation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ruan Xinmin
    Organizational Affiliation
    Guangzhou University of Chinese Medecine
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25592946
    Citation
    Lin Y, Wang YF, Lin DQ, Chen JW, Li JZ, Lan TH, Ou AH, Ruan XM. Efficacy and safety of Huxin formula in patients after CABG: a multicenter, double-blind, randomized clinical trial. Forsch Komplementmed. 2014;21(6):351-9. doi: 10.1159/000370010. Epub 2014 Dec 11.
    Results Reference
    derived

    Learn more about this trial

    Effect of Chinese Traditional Medicine for Post Revascularization Treatment of Coronary Artery Disease

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