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

This study has been completed.
Sponsor:
Collaborators:
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 Province people Hospital
Shaanxi Provincial People's Hospital
First Affiliated Hospital, Sun Yat-Sen University
Guangxi Medical University
Information provided by:
Guangzhou University of Chinese Medicine
ClinicalTrials.gov Identifier:
NCT00965471
First received: August 24, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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 Intervention
Percutaneous Coronary Artery Intervention
Coronary Artery Bypass Graft
Acute Coronary Syndrome
Drug: cipher prescription 1
Drug: cipher prescription 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Effect of Chinese Traditional Medicine for Post Revascularization Treatment of Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by Guangzhou University of Chinese Medicine:

Primary Outcome Measures:
  • dead [ Time Frame: 180±3days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • cardiovascular event [ Time Frame: 180±3days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 940
Study Start Date: October 2006
Study Completion Date: June 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Province people 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

No publications provided

ClinicalTrials.gov Identifier: NCT00965471     History of Changes
Other Study ID Numbers: 2006BAI04A01
Study First Received: August 24, 2009
Last Updated: August 24, 2009
Health Authority: China: Ministry of Health

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
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014