Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| China Academy of Chinese Medical Sciences | OTHER |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether Danlou Tablet 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. Danlou Tablet, a kind of Chinese patent medicine has been used for treating coronary artery disease in clinical practice in China for many years.
Danlou Tablet is applicable to "phlegm-stasis syndrome" in Traditional Chinese Medicine. According to recent studies, Danlou Tablet can reduce blood lipid level and myocardial necrosis area ,promote infarct healing in rats.And it can improve clinical symptoms of patients with CAD.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Danlou Tablet | Experimental | Danlou 0.3g tablet by mouth, 5 tablets 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) |
|
| Danlou Tablet placebo | Placebo Comparator | Placebo Danlou 0.3g tablet by mouth, 5 tablets 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 |
|---|---|---|---|---|
| Danlou Tablet | Drug | Conventional western medicine & Danlou Tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Death caused by cardiovascular disease | Six months after randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Ejection fraction percentage (EF%) | One of Echocardiographic parameters | At baseline (before randomisation), and six months after randomisation |
| E/A ratio | One of Echocardiographic parameters |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
| 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| DanLou Tablet placebo |
| Drug |
Conventional western medicine & placebo (for Danlou Tablet) |
|
| Aspirin Enteric-coated Tablets | Drug | 100 mg 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 | One 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. |
| 26142341 | Result | Wang L, Mao S, Qi JY, Ren Y, Guo XF, Chen KJ, Zhang MZ. Effect of Danlou Tablet () on peri-procedural myocardial injury among patients undergoing percutaneous coronary intervention for non-ST elevation acute coronary syndrome: A study protocol of a multicenter, randomized, controlled trial. Chin J Integr Med. 2015 Sep;21(9):662-6. doi: 10.1007/s11655-015-2284-1. Epub 2015 Jul 4. |
| 23173251 | Result | Wang SH, Wang J, Li J. [Efficacy assessment of treating patients with coronary heart disease angina of phlegm and stasis mutual obstruction syndrome by Danlou tablet]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2012 Aug;32(8):1051-5. Chinese. |
| 27491230 | Result | Chen J, Cai HW, Miao J, Xu XM, Mao W. [Danlou Tablet Fought against Inflammatory Reaction in Atherosclerosis Rats with Intermingled Phlegm and Blood Stasis Syndrome and Its Mechanism Study]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2016 Jun;36(6):703-8. Chinese. |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000629101 | danlou tablet |
| 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 |
Not provided
Not provided