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This study is a randomized, double-blind, placebo-controlled, parallel clinical trial in Chinese population with stable angina pectoris. The purpose is to determine the efficacy and safety of Xueshuanxinmaining tablet in the treatment of stable angina pectoris.
Xueshuanxinmaining tablet is a Chinese patent medicine composed of Ligusticum chuanxiong, Salvia miltiorrhiza, borneol and Toad puff, etc. It has been widely used in cardiovascular diseases in China. Clinical application suggested that Xueshuanxinmaining tablet was safe and effective in the treatment of stable angina pectoris. However, it still needs to be further confirmed by high-quality, large sample randomized controlled trials. This randomized, double-blind, placebo-controlled clinical trial is to determine the efficacy and safety of Xueshuanxinmaining tablet in the treatment of stable angina pectoris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xueshuanxinmaining Tablet | Experimental | Patients were given Xueshuanxinmaining tablet orally 2 pills each time, 3 times daily for 8 weeks. And patients can take nitroglycerin tablets provided by the sponsor when angina attack. For patients who have used drugs such as aspirin, angiotensin-converting enzyme inhibitor, lipid-lowering drugs to treat coronary heart disease before inclusion, they can continue to use the original varieties and doses, without dose adjustment. |
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| Placebo | Placebo Comparator | Patients were given Xueshuanxinmaining tablet simulation orally 2 pills each time, 3 times daily for 8 weeks. And patients can take nitroglycerin tablets provided by the sponsor when angina attack. For patients who have used drugs such as aspirin, angiotensin-converting enzyme inhibitor, lipid-lowering drugs to treat coronary heart disease before inclusion, they can continue to use the original varieties and doses, without dose adjustment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xueshuanxinmaining tablet | Drug | A kind of Chinese patent medicine |
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| Measure | Description | Time Frame |
|---|---|---|
| Stopping or reducing rate of antianginal drugs | Antianginal drugs include nitroglycerin tablet, compound Danshen dropping pill and Suxiao Jiuxin pill. | Eight weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Stopping or reducing rate of antianginal drugs | Antianginal drugs include nitroglycerin tablet, compound Danshen dropping pill and Suxiao Jiuxin pill. | Two, four and eight weeks after treatment |
| Changes of electrocardiogram (ECG) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Li, MD | Contact | +86 13051458913 | gamyylj@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Li, MD | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Study Director |
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| Xueshuanxinmaining placebo | Drug | The simulant of Xueshuanxinmaining tablet |
|
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| Nitroglycerin tablets | Drug | Be used when angina attack |
|
Mainly observe the ST segment and the change of T wave from the baseline
| Four and eight weeks after treatment |
| Changes of Seattle Angina Questionnaire scores (SAQ scores) | The SAQ regroups 19 items measuring five specific scales: physical limitations, anginal stability, anginal frequency, treatment satisfaction and disease perception targeting a specific disease and treatment group. higher scores mean a better outcome. | Four and eight weeks after treatment |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005996 | Nitroglycerin |
| ID | Term |
|---|---|
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
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