Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 4, 2009
May 31, 2012
March 2008
March 2009   (final data collection date for primary outcome measure)
Severity of anginal attacks, alternations of TCM symptoms and signs, and electrocardiographic changes. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00817024 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Coronary Heart Disease
  • 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
  • Experimental: Xuefu Zhuyu Capsules
    Intervention: Drug: Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules,
  • Active Comparator: Sheng Mai Capsules
    Intervention: Drug: Sheng Mai Capsules Plus Placebo of Xuefu Zhuyu Capsules
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo of Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules
Chu FY, Wang J, Yao KW, Li ZZ. Effect of Xuefu Zhuyu Capsule (血府逐瘀胶囊) on the symptoms and signs and health-related quality of life in the unstable angina patients with blood-stasis syndrome after percutaneous coronary intervention: A Randomized controlled trial. Chin J Integr Med. 2010 Oct;16(5):399-405. doi: 10.1007/s11655-010-9999-9. Epub 2010 Jun 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00817024
NNSF90709048
Yes
China Academy of Chinese Medical Sciences, Guang'an Men Hospital
Guang'an Men Hospital
Beijing Anzhen Hospital
Principal Investigator: Jie Wang, M.D. China Academy of Chinese Medical Sciences
Guang'an Men Hospital
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP