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

August 24, 2009 updated by: Guangzhou University of Chinese Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

940

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
dead
Time Frame: 180±3days
180±3days

Secondary Outcome Measures

Outcome Measure
Time Frame
cardiovascular event
Time Frame: 180±3days
180±3days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou University of Chinese Medicine

Collaborators

First Affiliated Hospital, Sun Yat-Sen University
Shanghai 10th People's Hospital
Beijing Tongren Hospital
Guangdong Provincial People's Hospital
Beijing Anzhen Hospital
Xiyuan Hospital of China Academy of Chinese Medical Sciences
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
PLA.The Military General Hospital of Beijing
The Sixth Affliated Hospital of Jinan University
Gansu Provincial Hospital
Shaanxi Provincial People's Hospital
The Fifth Affliated Hospital of Guangxi Medical University

Investigators

  • Study Chair: Ruan Xinmin, Guangzhou University of Chinese Medecine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

August 24, 2009

First Submitted That Met QC Criteria

August 24, 2009

First Posted (Estimate)

August 25, 2009

Study Record Updates

Last Update Posted (Estimate)

August 25, 2009

Last Update Submitted That Met QC Criteria

August 24, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006BAI04A01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Coronary Syndrome

Clinical Trials on cipher prescription 1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe