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

NCT ID: NCT00965471

Last Updated: 2009-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

940 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Percutaneous Coronary Artery Intervention Coronary Artery Bypass Graft Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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managed group

Group Type EXPERIMENTAL

cipher prescription 1

Intervention Type DRUG

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

control group

Group Type PLACEBO_COMPARATOR

cipher prescription 2

Intervention Type DRUG

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

Interventions

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cipher prescription 1

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

Intervention Type DRUG

cipher prescription 2

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiyuan Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role collaborator

China-Japan Friendship Hospital

OTHER

Sponsor Role collaborator

Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region

UNKNOWN

Sponsor Role collaborator

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Teaching Hospital of Nanjin University of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Second People's Hospital, Fujian Province

OTHER

Sponsor Role collaborator

Liaoning University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Guangzhou Overseas Chinese Hospital

UNKNOWN

Sponsor Role collaborator

Beijing Tongren Hospital

OTHER

Sponsor Role collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role collaborator

PLA.The Military General Hospital of Beijing

UNKNOWN

Sponsor Role collaborator

The Sixth Affliated Hospital of Jinan University

UNKNOWN

Sponsor Role collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role collaborator

Gansu Provincial Hospital

OTHER

Sponsor Role collaborator

Shaanxi Provincial People's Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

The Fifth Affliated Hospital of Guangxi Medical University

UNKNOWN

Sponsor Role collaborator

Guangzhou University of Chinese Medicine

OTHER

Sponsor Role lead

Principal Investigators

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Ruan Xinmin

Role: STUDY_CHAIR

Guangzhou University of Chinese Medecine

References

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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.

Reference Type DERIVED
PMID: 25592946 (View on PubMed)

Other Identifiers

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2006BAI04A01

Identifier Type: -

Identifier Source: org_study_id

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