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

This study has been completed.
Sponsor:
Collaborator:
Beijing Anzhen Hospital
Information provided by:
Guang'an Men Hospital
ClinicalTrials.gov Identifier:
NCT00817024
First received: January 4, 2009
Last updated: May 31, 2012
Last verified: January 2009
History of Changes
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Study of Herbal Formula in Post PCI Patients.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Guang'an Men Hospital:

Primary Outcome Measures:
  • Severity of anginal attacks, alternations of TCM symptoms and signs, and electrocardiographic changes. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: March 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817024

Locations
China
Guang'an Men Hospital
Beijing, China, 100053
Sponsors and Collaborators
Guang'an Men Hospital
Beijing Anzhen Hospital
Investigators
Principal Investigator: Jie Wang, M.D. China Academy of Chinese Medical Sciences
  More Information

No publications provided by Guang'an Men Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: China Academy of Chinese Medical Sciences, Guang'an Men Hospital
ClinicalTrials.gov Identifier: NCT00817024     History of Changes
Other Study ID Numbers: NNSF90709048
Study First Received: January 4, 2009
Last Updated: May 31, 2012
Health Authority: China: Ethics Committee

Keywords provided by Guang'an Men Hospital:
Coronary Heart Disease
PCI
Traditional Chinese Medicine
Quality of Life

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013