NCT00817024

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

Clinical Study of Herbal Formula in Post PCI Patients.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Heart Disease

Interventions

Type	Name	Description
DRUG	Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules,	3# XFZY capsules plus 3# placebo of SM capsules, po, Tid, for 4 weeks
DRUG	Sheng Mai Capsules Plus Placebo of Xuefu Zhuyu Capsules	3# SM capsules plus 3# placebo of XFZY capsules, po, Tid, for 4 weeks
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

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2009-01-06
• Last updated: 2012-06-01

Locations

1 site across 1 country: China