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A prospective, multi-center, double-blind, randomized, placebo-controlled trial is conducted to evaluate the efficacy and safety of Yinxingmihuan oral solution in the treatment of chest pain after percutaneous coronary intervention (PCI) in patients with stable angina. Patients should undergo at least 1-week standardized medical treatment phase before randomization. The primary end point is the 12-week angina frequency assessed on the basis of Seattle Angina Questionnaire (SAQ) subscales. The main secondary endpoint is the improvement of anxiety assessed by Hamilton Anxiety Scale (HAMA) to evaluate its effectiveness for chest pain caused by psychological factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yinxingmihuan group | Experimental | standardized medical treatment regimen plus Yinxingmihuan oral solution (oral, 10 ml once, 3 times a day) |
|
| Placebo group | Placebo Comparator | standardized medical treatment regimen plus Placebo oral solution (oral, 10 ml once, 3 times a day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yinxingmihuan oral solution | Drug | Yinxingmihuan oral solution is made of Ginkgo leaf extract and armillariella mellea powders. |
|
| Measure | Description | Time Frame |
|---|---|---|
| SAQ-angina frequency | angina frequency assessed on the basis of Seattle Angina Questionnaire (SAQ-AF) | at 12-week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| HAMA improvement | variation of the value of Hamilton Anxiety Scale (HAMA) at 12-week follow-up compared with baseline | at 12-week follow-up |
| CCS grade | angina grade assessed by Canadian Cardiovascular Society (CCS) |
| Measure | Description | Time Frame |
|---|---|---|
| SAQ-PL | Physical limitation assessed on the basis of Seattle Angina Questionnaire | before randomization, in 4,8,12,16 and 20 weeks |
| SAQ-AS | Anginal stability assessed on the basis of Seattle Angina Questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences | Beijing | 100037 | China |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C063170 | Ginkgo biloba extract |
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| Placebo | Drug | The placebo oral solution is in the same appearance, color, smell and taste as the experimental Yinxingmihuan oral solution. |
|
| before randomization, in 4,8,12,16 and 20 weeks |
| NYHA class | heart function assessed by New York Heart Association (NYHA) | before randomization, in 4,8,12,16 and 20 weeks |
| VAS | generic health status assessed by visual analogue scale (VAS) | before randomization, in 4,8,12,16 and 20 weeks |
| HAMA reductive ratio | variation of Hamilton Anxiety Scale (HAMA) score at 12-week follow-up compared with baseline divided by the baseline value | at 12-week follow-up |
| HAMD depression score | proportion of participants with improvement or disappear of depression according to Hamilton Depression Scale (HAMD) | before randomization, in 4,8,12,16 and 20 weeks |
| weekly angina frequency | weekly angina frequency recorded by the participants' diary cards | before randomization, in 4,8,12,16 and 20 weeks |
| SF-12 score | generic health status measured by 12-Item Short Form Health Survey (SF-12) | before randomization, in 4,8,12,16 and 20 weeks |
| Nitroglycerin discontinuation rate | proportion of participants that no longer need any nitroglycerin medications | before randomization, in 4,8,12,16 and 20 weeks |
| before randomization, in 4,8,12,16 and 20 weeks |
| SAQ-TS | Treatment satisfaction assessed on the basis of Seattle Angina Questionnaire | before randomization, in 4,8,12,16 and 20 weeks |
| SAQ-DP | Disease perception assessed on the basis of Seattle Angina Questionnaire | before randomization, in 4,8,12,16 and 20 weeks |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |