Curative Effect Evaluation of Shexiang Baoxin Pill on Coronary Artery Disease Not Amenable to Revascularization
NCT ID: NCT03072121
Last Updated: 2017-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
440 participants
INTERVENTIONAL
2017-06-30
2019-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Shexiang baoxin pill
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)
Shexiang Baoxin pill
Conventional western medicine \& shexiang baoxin pill
Aspirin Enteric-coated Tablets
100mg tablet, one tablet daily.
Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet
one tablet daily. (for patients who can't use aspirin)
Atorvastatin Calcium
10 mg tablet, two tablets each night.
Isosorbide Mononitrate Tab 20 MG
1 tablet two times daily.
Metoprolol Tartrate Tab 25 MG
12.5 mg or 25 mg two times daily.
Trimetazidine Dihydrochloride Tablets
20 mg tablet, one tablet three times daily.
SBP placebo
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)
SBP placebo
Conventional western medicine \& placebo (for shexiang baoxin pill)
Aspirin Enteric-coated Tablets
100mg tablet, one tablet daily.
Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet
one tablet daily. (for patients who can't use aspirin)
Atorvastatin Calcium
10 mg tablet, two tablets each night.
Isosorbide Mononitrate Tab 20 MG
1 tablet two times daily.
Metoprolol Tartrate Tab 25 MG
12.5 mg or 25 mg two times daily.
Trimetazidine Dihydrochloride Tablets
20 mg tablet, one tablet three times daily.
Interventions
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Shexiang Baoxin pill
Conventional western medicine \& shexiang baoxin pill
SBP placebo
Conventional western medicine \& placebo (for shexiang baoxin pill)
Aspirin Enteric-coated Tablets
100mg tablet, one tablet daily.
Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet
one tablet daily. (for patients who can't use aspirin)
Atorvastatin Calcium
10 mg tablet, two tablets each night.
Isosorbide Mononitrate Tab 20 MG
1 tablet two times daily.
Metoprolol Tartrate Tab 25 MG
12.5 mg or 25 mg two times daily.
Trimetazidine Dihydrochloride Tablets
20 mg tablet, one tablet three times daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with CAD complicated with severe multiple organ disease such as severe heart failure, severe lung, liver or renal dysfunction, peptic ulcer in active stage, or intracranial hemorrhage
* Patients that use high-dose steroids due to connective tissue disease
* Patients with serious infections
* Patients with malignant tumor
* Patients with hematopoietic diseases
* Pregnant or lactating women.
45 Years
75 Years
ALL
No
Sponsors
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Shanghai Hutchison Pharmaceuticals Limited
INDUSTRY
Jun Li
OTHER
Responsible Party
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Jun Li
Director of Cardiology
Principal Investigators
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Jie Wang, MD
Role: STUDY_DIRECTOR
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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SBP-2016
Identifier Type: -
Identifier Source: org_study_id
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