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

Study Overview
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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.

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.

Official Title
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Clinical Study of Herbal Formula in Post PCI Patients.

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Drug: Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules,
* Drug: Sheng Mai Capsules Plus Placebo of Xuefu Zhuyu Capsules
* Drug: Placebo of Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Heart Disease, PCI, Traditional Chinese Medicine, Quality of Life