Clinical trial NCT00817024: Study of Herbal Formula Corresponding to Syndrome in Treating Post Percutaneous Coronary Intervention (PCI) Patients With Coronary Heart Disease (CHD)
Official title: Clinical Study of Herbal Formula in Post PCI Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Keywords: Coronary Heart Disease
PCI
Traditional Chinese Medicine
Quality of Life
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Beijing Anzhen Hospital
First posted: 2009-01-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Severity of anginal attacks, alternations of TCM symptoms and signs, and electrocardiographic changes.
timeFrame: 4 weeks
Secondary outcomes:
measure: Health related quality of life (Hr-QoL); Changes in serum lipid, inflammatory reaction level and endothelial function status alternations before and after the treatment.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'an Men Hospital
Study officials:
affiliation: China Academy of Chinese Medical Sciences
name: Jie Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Chu FY, Wang J, Sun XW, Xing YW, Yao KW, Wang SH, Li ZZ. [A randomized double-blinded controlled trial of Xuefu Zhuyu Capsule on short-term quality of life in unstable anginal patients with blood-stasis syndrome after percutaneous coronary intervention]. Zhong Xi Yi Jie He Xue Bao. 2009 Aug;7(8):729-35. doi: 10.3736/jcim20090805. Chinese.