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| Name | Class |
|---|---|
| Beijing Anzhen Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xuefu Zhuyu Capsules | Experimental |
| |
| Sheng Mai Capsules | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules, | Drug | 3# XFZY capsules plus 3# placebo of SM capsules, po, Tid, for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity of anginal attacks, alternations of TCM symptoms and signs, and electrocardiographic changes. | 4 weeks |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jie Wang, M.D. | China Academy of Chinese Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'an Men Hospital | Beijing | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20535581 | Derived | 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. | |
| 19671410 |
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| 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 |
|
| 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. |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C513826 | Xue-Fu-Zhu-Yu decoction |
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