NCT00965471

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
940

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2006

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
Last Updated

August 25, 2009

Status Verified

August 1, 2009

Enrollment Period

2 years

First QC Date

August 24, 2009

Last Update Submit

August 24, 2009

Conditions

Percutaneous Coronary Artery InterventionCoronary Artery Bypass GraftAcute Coronary Syndrome

Keywords

percutaneous coronary artery interventioncoronary artery bypass graftacute coronary syndrome

Outcome Measures

Primary Outcomes (1)

  • dead

    180±3days

Secondary Outcomes (1)

  • cardiovascular event

    180±3days

Study Arms (2)

managed group

EXPERIMENTAL
Drug: cipher prescription 1

control group

PLACEBO COMPARATOR
Drug: cipher prescription 2

Interventions

cipher prescription 1DRUG

Drug granules include ginseng,RADIX NOTOGINSENG,prepared RHIZOMA PINELLIAE with alumen radix glyrrhigae calcaren once daily for 180 days

managed group
cipher prescription 2DRUG

Placebo include amidon、bitter principles and diluents bases once daily for 180 days

control group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 25592946DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Ruan Xinmin

    Guangzhou University of Chinese Medecine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 25, 2009

Study Start

October 1, 2006

Primary Completion

October 1, 2008

Study Completion

June 1, 2009

Last Updated

August 25, 2009

Record last verified: 2009-08