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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00965471
• Other study ID #: 2006BAI04A01
• Status: Completed
• Phase: N/A
• First received: August 24, 2009
• Last updated: August 24, 2009
• Start date: October 2006
• Est. completion date: June 2009

Study information

• Verified date: August 2009
• Source: Guangzhou University of Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 940
• Est. completion date: June 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Bypass Graft
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Percutaneous Coronary Artery Intervention

Intervention

Drug:
• cipher prescription 1
Drug granules include ginseng,RADIX NOTOGINSENG,prepared RHIZOMA PINELLIAE with alumen radix glyrrhigae calcaren once daily for 180 days
• cipher prescription 2
Placebo include amidon?bitter principles and diluents bases once daily for 180 days

Locations

Country	Name	City	State
n/a

Sponsors (19)

Lead Sponsor

Collaborator

Guangzhou University of Chinese Medicine

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dead		180±3days	Yes
Secondary	cardiovascular event		180±3days	Yes