Efficacy and Safety of Xueshuanxinmaining Tablet for the Treatment of Stable Angina Pectoris
NCT ID: NCT04270279
Last Updated: 2020-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2020-12-31
2021-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Xueshuanxinmaining Tablet
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.
Xueshuanxinmaining tablet
A kind of Chinese patent medicine
Nitroglycerin tablets
Be used when angina attack
Placebo
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.
Xueshuanxinmaining placebo
The simulant of Xueshuanxinmaining tablet
Nitroglycerin tablets
Be used when angina attack
Interventions
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Xueshuanxinmaining tablet
A kind of Chinese patent medicine
Xueshuanxinmaining placebo
The simulant of Xueshuanxinmaining tablet
Nitroglycerin tablets
Be used when angina attack
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
30 Years
75 Years
ALL
No
Sponsors
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Jun Li
Chief physician
Principal Investigators
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Jun Li, MD
Role: STUDY_DIRECTOR
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Central Contacts
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Other Identifiers
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XSXMN_2019001
Identifier Type: -
Identifier Source: org_study_id