Efficacy and Safety of Yangxin Shengmai Granules 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 Yangxin Shengmai Granules in the treatment of stable angina pectoris.

Detailed Description
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Yangxin Shengmai granules is a Chinese patent medicine composed of ginseng, Ophiopogon japonicus, Salvia miltiorrhiza, Schisandra chinensis, etc. It is used for the treatment of chest pain caused by Qi-yin deficiency and blood stasis in traditional Chinese medicine. The symptoms include chest tightness, chest pain, palpitation, shortness of breath, fatigue, dry mouth and dry throat. Clinical applications suggested that Yangxin Shengmai granules were safe and effective in the treatment of coronary heart disease. However, high-quality clinical trials are still needed to further confirm, so as to provide theoretical basis for the treatment of stable angina pectoris with traditional Chinese medicine. The study is designed to determine the efficacy and safety of Yangxin Shengmai Granules in the treatment of stable angina pectoris.

Official Title
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Efficacy and Safety of Yangxin Shengmai Granules for the Treatment of Stable Angina Pectoris: Randomised, Double Blind, Placebo Controlled Trial

Conditions
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Coronary Heart Disease, Stable Angina

Intervention / Treatment
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* Drug: Yangxin Shengmai
* Drug: Yangxin Shengmai 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: 40 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yangxin Shengmai Granules<br>Patients were given Yangxin Shengmai granules orally 14g (1 bag) each time, 3 times daily for 4 weeks. And nitroglycerin tablets are used 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: Yangxin Shengmai<br>* Yangxin Shengmai Granules<br>* Other names: YXSM;Drug: nitroglycerin tablets<br>* Be used when angina attack<br>|
| Placebo Comparator: Placebo<br>Patients were given Yangxin Shengmai granules simulation orally 14g (1 bag) each time, 3 times daily for 4 weeks. And nitroglycerin tablets are used 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: Yangxin Shengmai placebo<br>* Yangxin Shengmai placebo have an identical appearance and scent as the active treatment granules.<br>* Other names: YXSM 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 the nitroglycerin tablets | Number of nitroglycerin tablets used before medication - number of nitroglycerin tablets used after medication) / number of nitroglycerin tablets used before medication × 100% | Four weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of angina symptom score | The angina symptom score regroups three items: degree of the frequency, duration and severity of angina attacks. The score of each item is 0,2,4,6. And higher scores mean a worse outcome. | Two and four weeks after treatment | 
| Patient-reported outcomes in coronary heart disease | Through clinical outcome evaluation scale for patients with coronary heart disease with angina pectoris | Two and four weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Yangxinshengmai granules, Stable angina pectoris, Coronary heart disease, Randomized controlled trial