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

Coronary Heart Disease Clinical Trial

Official title:

Clinical Study of Herbal Formula in Post PCI Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00817024
• Other study ID #: NNSF90709048
• Status: Completed
• Phase: N/A
• First received: January 4, 2009
• Last updated: May 31, 2012
• Start date: March 2008
• Est. completion date: March 2009

Study information

• Verified date: January 2009
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules,
3# XFZY capsules plus 3# placebo of SM capsules, po, Tid, for 4 weeks
• Sheng Mai Capsules Plus Placebo of Xuefu Zhuyu Capsules
3# SM capsules plus 3# placebo of XFZY capsules, po, Tid, for 4 weeks
• 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

Locations

Country	Name	City	State
China	Guang'an Men Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences	Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of anginal attacks, alternations of TCM symptoms and signs, and electrocardiographic changes.		4 weeks	No
Secondary	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	No