Curative Effect Evaluation of Shexiang Baoxin Pill on Coronary Artery Disease Not Amenable to Revascularization

Jun Li

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease(CAD)

Treatments: Drug: Atorvastatin Calcium; Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet; Drug: SBP placebo; Drug: Isosorbide Mononitrate Tab 20 MG; Drug: Metoprolol Tartrate Tab 25 MG; Drug: Shexiang Baoxin pill; Drug: Trimetazidine Dihydrochloride Tablets; Drug: Aspirin Enteric-coated Tablets

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03072121

SBP-2016

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 440 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants are aged between 45 and 75 years, diagnosed with sever CAD through coronary arteriography which shows that the left main coronary artery and three-vessel have sever diffuse stenosis, calcification or vascular ectasia, be in accordance with Traditional Chinese Medicine syndrome of "Qi deficiency and blood stasis syndrome" or "phlegm and stasis mu-tual obstruction syndrome".

Exclusion criteria

• Patients with severe valvular disease, congenital cardiomyopathy decompensation
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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440 participants in 2 patient groups, including a placebo group

Shexiang baoxin pill

Experimental group

Description:

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)

Treatment:

Drug: Trimetazidine Dihydrochloride Tablets

Drug: Aspirin Enteric-coated Tablets

Drug: Metoprolol Tartrate Tab 25 MG

Drug: Isosorbide Mononitrate Tab 20 MG

Drug: Shexiang Baoxin pill

Drug: Atorvastatin Calcium

Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet

SBP placebo

Placebo Comparator group

Description:

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)

Treatment:

Drug: Trimetazidine Dihydrochloride Tablets

Drug: Aspirin Enteric-coated Tablets

Drug: SBP placebo

Drug: Metoprolol Tartrate Tab 25 MG

Drug: Isosorbide Mononitrate Tab 20 MG

Drug: Atorvastatin Calcium

Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet