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Completed

NCT Number: NCT00817024

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guang'an Men Hospital

Beijing, 100053, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules,

Drug

3# XFZY capsules plus 3# placebo of SM capsules, po, Tid, for 4 weeks

Sheng Mai Capsules Plus Placebo of Xuefu Zhuyu Capsules

Drug

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

Drug

3# Placebo of XFZY capsules plus 3# placebo of SM capsules, po, Tid, for 4 weeks

Primary outcomes

  1. Severity of anginal attacks, alternations of TCM symptoms and signs, and electrocardiographic changes.

    Time frame: 4 weeks

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other

Collaborators

  • Beijing Anzhen Hospital

Registry information

Official study title

Clinical Study of Herbal Formula in Post PCI Patients.

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 6, 2009
Registry last updated
Jun 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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