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

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Xuefu Zhuyu Capsules

Group Type EXPERIMENTAL

Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules,

Intervention Type DRUG

3# XFZY capsules plus 3# placebo of SM capsules, po, Tid, for 4 weeks

Sheng Mai Capsules

Group Type ACTIVE_COMPARATOR

Sheng Mai Capsules Plus Placebo of Xuefu Zhuyu Capsules

Intervention Type DRUG

3# SM capsules plus 3# placebo of XFZY capsules, po, Tid, for 4 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo of Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules

Intervention Type DRUG

3# Placebo of XFZY capsules plus 3# placebo of SM capsules, po, Tid, for 4 weeks

Interventions

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Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules,

3# XFZY capsules plus 3# placebo of SM capsules, po, Tid, for 4 weeks

Intervention Type DRUG

Sheng Mai Capsules Plus Placebo of Xuefu Zhuyu Capsules

3# SM capsules plus 3# placebo of XFZY capsules, po, Tid, for 4 weeks

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No