Efficacy and Safety of Yangxin Shengmai Granules for the Treatment of Stable Angina Pectoris: Randomised, Double Blind, Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 主要终点
- Stopping or reducing rate of the nitroglycerin tablets
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Yangxin Shengmai Granules
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.
干预措施: Yangxin Shengmai (Drug)
Yangxin Shengmai Granules
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.
干预措施: nitroglycerin tablets (Drug)
Placebo
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.
干预措施: Yangxin Shengmai placebo (Drug)
Placebo
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.
干预措施: nitroglycerin tablets (Drug)
结局指标
主要结局
Stopping or reducing rate of the nitroglycerin tablets
时间窗: Four weeks after treatment
Number of nitroglycerin tablets used before medication - number of nitroglycerin tablets used after medication) / number of nitroglycerin tablets used before medication × 100%
次要结局
- Patient-reported outcomes in coronary heart disease(Two and four weeks after treatment)
- Changes of angina symptom score(Two and four weeks after treatment)
研究者
Jun Li
Chief physician
Guang'anmen Hospital of China Academy of Chinese Medical Sciences