Study of Herbal Formula Corresponding to Syndrome in Treating Post Percutaneous Coronary Intervention (PCI) Patients With Coronary Heart Disease (CHD)

May 31, 2012 updated by: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Clinical Study of Herbal Formula in Post PCI Patients.

We conduct this clinical trial to determine the effects of Xuefu Zhuyu capsule (based on TCM "Zheng Hou" theory) in helping recovery from coronary heart disease(CHD)after PCI and find out whether this kind of effecacy is much better within patients administered with TCM syndrome-based individualized medication.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The effectiveness of a Chinese herbal formulae is not completely based on the disease or some biomedical indexes, but much more on the TCM syndrome(Chinese name:Zheng Hou)which is generalized from patients' TCM signs and symptoms. Thus, conventional medical curative effecacy evaluation system seems not to so fit for TCM clinical studies. Although many clinical studies from Chinese literature have reported the beneficial effects of various of TCM herbal agents in improving symptoms and signs as well as antagonism of specific pathological changes in CHD patients, most of these trials are lack of well-designed methodologies and the reliability of results still remains unclear. Therefore, we designed this clinical trial, with a randomized, placebo controlled way, to evaluate the curative effects of Xuefu Zhuyu capsule(a Chinese herbal medicine)in patients with Post-PCI CHD patients and find out whether this effects will be better displayed within subjects administered with syndrome-based individualized medication.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100053
        • Guang'an Men Hospital

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-75 years old
  • Clinical diagnosis of coronary heart disease (confirmed by coronary angiography)
  • Successfully received interventional therapy (PTCA or PCI)
  • belong to TCM blood-stasis syndrome
  • Must be able to swallow tablets
  • Able to give written informed consent

Exclusion Criteria:

  • Symptomatic congestive heart failure(New York Heart Association class III-IV)
  • Females during pregnancy or lactation
  • Serious dysfunction in important organs (liver, lung, kidney，et al)
  • Use of concomitant Chinese herbal medicine
  • Already attend other clinical trial

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo of Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules
3# Placebo of XFZY capsules plus 3# placebo of SM capsules, po, Tid, for 4 weeks
Experimental: Xuefu Zhuyu Capsules
Drug: Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules,
3# XFZY capsules plus 3# placebo of SM capsules, po, Tid, for 4 weeks
Active Comparator: Sheng Mai Capsules
Drug: Sheng Mai Capsules Plus Placebo of Xuefu Zhuyu Capsules
3# SM capsules plus 3# placebo of XFZY capsules, po, Tid, for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Severity of anginal attacks, alternations of TCM symptoms and signs, and electrocardiographic changes.
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Health related quality of life (Hr-QoL); Changes in serum lipid, inflammatory reaction level and endothelial function status alternations before and after the treatment.
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

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

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Collaborators

Beijing Anzhen Hospital

Investigators

  • Principal Investigator: Jie Wang, M.D., China Academy of Chinese Medical Sciences

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

March 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

January 4, 2009

First Submitted That Met QC Criteria

January 5, 2009

First Posted (Estimate)

January 6, 2009

Study Record Updates

Last Update Posted (Estimate)

June 1, 2012

Last Update Submitted That Met QC Criteria

May 31, 2012

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NNSF90709048

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.

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