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

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00817024

Collaborator

Beijing Anzhen Hospital (Other)

Enrollment

Location

Arms

Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease	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	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Clinical Study of Herbal Formula in Post PCI Patients.

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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
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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

Severity of anginal attacks, alternations of TCM symptoms and signs, and electrocardiographic changes. [4 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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