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

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: NCT00965471
Recruitment Status : Completed
First Posted : August 25, 2009
Last Update Posted : August 25, 2009
Sponsor:
Collaborators:
Information provided by:

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.

Condition or disease Intervention/treatment
Percutaneous Coronary Artery Intervention Coronary Artery Bypass Graft Acute Coronary Syndrome Drug: cipher prescription 1 Drug: cipher prescription 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 940 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effect of Chinese Traditional Medicine for Post Revascularization Treatment of Coronary Artery Disease
Study Start Date : October 2006
Primary Completion Date : October 2008
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: managed group Drug: cipher prescription 1
Drug granules include ginseng,RADIX NOTOGINSENG,prepared RHIZOMA PINELLIAE with alumen radix glyrrhigae calcaren once daily for 180 days
Placebo Comparator: control group Drug: cipher prescription 2
Placebo include amidon、bitter principles and diluents bases once daily for 180 days


Outcome Measures

Primary Outcome Measures :
  1. dead [ Time Frame: 180±3days ]

Secondary Outcome Measures :
  1. cardiovascular event [ Time Frame: 180±3days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00965471


Sponsors and Collaborators
Guangzhou University of Chinese Medicine
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Guangdong General 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
Guangxi Medical University
Investigators
Study Chair: Ruan Xinmin Guangzhou University of Chinese Medecine
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00965471     History of Changes
Other Study ID Numbers: 2006BAI04A01
First Posted: August 25, 2009    Key Record Dates
Last Update Posted: August 25, 2009
Last Verified: August 2009

Keywords provided by Guangzhou University of Chinese Medicine:
percutaneous coronary artery intervention
coronary artery bypass graft
acute coronary syndrome

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases