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| Name | Class |
|---|---|
| Shanghai Hutchison Pharmaceuticals Limited | INDUSTRY |
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The purpose of this study is to determine whether Shexiang Baoxin Pill is effective in the treatment of coronary artery disease not amenable to revascularization on the basis of western medicine therapy.
The western medicine treatment for CAD not amenable to revascularization is limited. Shexiang Baoxin Pill, a kind of Chinese patent medicine has been used for treating coronary artery disease in clinical practice in China for many years.
Shexiang baoxin pill(SBP) is applicable to "Qi deficiency and blood stasis syndrome" in traditional Chinese medicine. Recent experimental research has indicated that SBP can improve myocardial ischemia and promote therapeutic angiogenesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shexiang baoxin pill | Experimental | Shexiang baoxin 22.5mg pill by mouth,2 pills three times daily for 6 months & Conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets) |
|
| SBP placebo | Placebo Comparator | Placebo shexiang baoxin 22.5mg pill by mouth,2 pills three times daily for 6 months & Conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shexiang Baoxin pill | Drug | Conventional western medicine & shexiang baoxin pill |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Death caused by cardiovascular disease | Six months after randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Ejection fraction percentage (EF%) | One of the Echocardiographic parameters | At baseline (before randomisation), and six months after randomisation. |
| E/A ratio | One of the Echocardiographic parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Li, MD | Contact | +86 13051458913 | 13051458913@163.com | |
| Panpan Tian | Contact | +86 15652388175 | 15652388175@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jie Wang, MD | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27480425 | Result | Zhao D. [Why dentists need to learn the epidemiological status and prevention strategy of coronary heart disease in China]. Zhonghua Kou Qiang Yi Xue Za Zhi. 2016 Jul;51(7):385-6. doi: 10.3760/cma.j.issn.1002-0098.2016.07.001. Chinese. | |
| 20681275 | Result | Zhu H, Luo XP, Wang LJ. [Evaluation on clinical effect of long-term shexiang baoxin pill administration for treatment of coronary heart disease]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2010 May;30(5):474-7. Chinese. |
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| SBP placebo | Drug | Conventional western medicine & placebo (for shexiang baoxin pill) |
|
| Aspirin Enteric-coated Tablets | Drug | 100mg tablet, one tablet daily. |
|
| Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet | Drug | one tablet daily. (for patients who can't use aspirin) |
|
|
| Atorvastatin Calcium | Drug | 10 mg tablet, two tablets each night. |
|
|
| Isosorbide Mononitrate Tab 20 MG | Drug | 1 tablet two times daily. |
|
|
| Metoprolol Tartrate Tab 25 MG | Drug | 12.5 mg or 25 mg two times daily. |
|
|
| Trimetazidine Dihydrochloride Tablets | Drug | 20 mg tablet, one tablet three times daily. |
|
|
| At baseline (before randomisation), and six months after randomisation. |
| C-reactive protein (CRP) | CRP in μg/L | At baseline(before randomisation), and six months after randomisation. |
| B-type natriuretic peptide (BNP) | BNP in pg/mL | At baseline (before randomisation), and six months after randomisation. |
| Hospital readmission rates | Hospital readmission rates due to coronary artery disease during treatment | At baseline (before randomisation), and six months after randomisation. |
| 27847338 | Result | Zhou Z, Shen W, Yu L, Xu C, Wu Q. A Chinese patent medicine, Shexiang Baoxin Pill, for Non-ST-elevation acute coronary syndromes: A systematic review. J Ethnopharmacol. 2016 Dec 24;194:1130-1139. doi: 10.1016/j.jep.2016.11.024. Epub 2016 Nov 12. |
| 20432394 | Result | Williams B, Menon M, Satran D, Hayward D, Hodges JS, Burke MN, Johnson RK, Poulose AK, Traverse JH, Henry TD. Patients with coronary artery disease not amenable to traditional revascularization: prevalence and 3-year mortality. Catheter Cardiovasc Interv. 2010 May 1;75(6):886-91. doi: 10.1002/ccd.22431. |
| 20531008 | Result | Gupta S, Pressman GS, Morris DL, Figueredo VM. Distribution of left ventricular ejection fraction in angina patients with severe coronary artery disease not amenable to revascularization. Coron Artery Dis. 2010 Aug;21(5):278-80. doi: 10.1097/MCA.0b013e32833bdf53. |
| 23303884 | Result | Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586. |
| 22019563 | Result | Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011;9(8):672-7. doi: 10.1016/j.ijsu.2011.09.004. Epub 2011 Oct 13. No abstract available. |
| 29444778 | Derived | Tian PP, Li J, Gao J, Li Y. Efficacy and safety of the Shexiang Baoxin Pill for the treatment of coronary artery disease not amenable to revascularisation: study protocol for a randomised, placebo-controlled, double-blinded trial. BMJ Open. 2018 Feb 14;8(2):e018052. doi: 10.1136/bmjopen-2017-018052. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C526712 | shexiang baoxin |
| D000077144 | Clopidogrel |
| D013607 | Tablets |
| D000069059 | Atorvastatin |
| C030397 | isosorbide-5-mononitrate |
| D008790 | Metoprolol |
| D014292 | Trimetazidine |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |
| D010879 | Piperazines |
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