Coronary Heart Disease
Conditions
Keywords
Coronary Heart Disease, PCI, Traditional Chinese Medicine, Quality of Life
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.
Interventions
DRUGXuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules,
3# XFZY capsules plus 3# placebo of SM capsules, po, Tid, for 4 weeks
DRUGSheng Mai Capsules Plus Placebo of Xuefu Zhuyu Capsules
3# SM capsules plus 3# placebo of XFZY capsules, po, Tid, for 4 weeks
DRUGPlacebo 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
Sponsors
Beijing Anzhen Hospital
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of anginal attacks, alternations of TCM symptoms and signs, and electrocardiographic changes. | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Outcome results
None listed