Coronary Heart Disease, Stable Angina
Conditions
Keywords
Coronary heart disease, Stable angina, Traditional Chinese medicine, Xueshuanxinmaining tablet
Brief summary
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
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.
Interventions
DRUGXueshuanxinmaining tablet
A kind of Chinese patent medicine
DRUGXueshuanxinmaining placebo
The simulant of Xueshuanxinmaining tablet
Be used when angina attack
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stopping or reducing rate of antianginal drugs | Eight weeks after treatment | Antianginal drugs include nitroglycerin tablet, compound Danshen dropping pill and Suxiao Jiuxin pill. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stopping or reducing rate of antianginal drugs | Two, four and eight weeks after treatment | Antianginal drugs include nitroglycerin tablet, compound Danshen dropping pill and Suxiao Jiuxin pill. |
| Changes of electrocardiogram (ECG) | Four and eight weeks after treatment | Mainly observe the ST segment and the change of T wave from the baseline |
| Changes of Seattle Angina Questionnaire scores (SAQ scores) | Four and eight weeks after treatment | 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. |
Contacts
Primary ContactJun Li, MD
Outcome results
None listed