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

Not Applicable

Completed

• Conditions: Coronary Heart Disease
• Interventions: 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

• Registration Number: NCT00817024
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

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 Timeline

• Study Start: 2008-03
• Status Verified: 2009-01
• Study First Submitted: 2009-01-04
• Study First Submitted QC: 2009-01-05
• Study First Posted: 2009-01-06
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xuefu Zhuyu Capsules	Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules,	-
Sheng Mai Capsules	Sheng Mai Capsules Plus Placebo of Xuefu Zhuyu Capsules	-
Placebo	Placebo of Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules	-

Primary Outcome Measures

Name	Time	Method
Severity of anginal attacks, alternations of TCM symptoms and signs, and electrocardiographic changes.	4 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Guang'an Men Hospital; 🇨🇳 Beijing, China