Efficacy and Safety of Xueshuanxinmaining Tablet for the Treatment of Stable Angina Pectoris

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and Safety of Xueshuanxinmaining Tablet for the Treatment of Stable Angina Pectoris: Multicenter, Randomised, Double Blind, Placebo Controlled Trial

Conditions
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Coronary Heart Disease, Stable Angina

Intervention / Treatment
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* Drug: Xueshuanxinmaining tablet
* Drug: Xueshuanxinmaining placebo
* Drug: Nitroglycerin tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants are aged between 40 and 75 years. Meet the diagnostic criteria of stable angina pectoris. Meet Chinese medicine syndrome differentiation of Qi-yin deficiency and blood stasis syndrome. Voluntarily participate and sign informed consent. Exclusion Criteria: Patients were diagnosed as acute myocardial infarction, unstable angina, stable exertion angina and other heart diseases. Patients with poor control of hypertension and diabetes, severe cardiopulmonary insufficiency, severe arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.), with a history of heart pacemaker or cerebrovascular disease within one year. Any of the following disease history or evidence was found in the screening period: severe cardiovascular or cerebrovascular diseases; active, recurrent peptic ulcer or other bleeding risk diseases; other serious diseases of digestive system; combined with malignant tumor, blood system disease, serious or progressive diseases of the other system; combined with mental diseases. Before screening, any laboratory inspection index meets the following standards: The results showed that Glutamic aspartate transaminase (AST) or alanine aminotransferase (ALT) were more than 1.5 times of the upper limit of normal value and serum creatinine (Cr) was more than 1.2 times of the upper limit of normal value. With a history of alcohol and drug abuse. Pregnant or lactating women. Patients who have participated in clinical trials of other drugs within 3 months before enrollment.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xueshuanxinmaining Tablet<br>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. | Drug: Xueshuanxinmaining tablet<br>* A kind of Chinese patent medicine<br>* Other names: XSXMN;Drug: Nitroglycerin tablets<br>* Be used when angina attack<br>|
| Placebo Comparator: Placebo<br>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. | Drug: Xueshuanxinmaining placebo<br>* The simulant of Xueshuanxinmaining tablet<br>* Other names: XSXMN placebo;Drug: Nitroglycerin tablets<br>* Be used when angina attack<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary heart disease, Stable angina, Traditional Chinese medicine, Xueshuanxinmaining tablet