Clinical trial NCT04270279: Efficacy and Safety of Xueshuanxinmaining Tablet for the Treatment of Stable Angina Pectoris
Official title: Efficacy and Safety of Xueshuanxinmaining Tablet for the Treatment of Stable Angina Pectoris: Multicenter, Randomised, Double Blind, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Heart Disease
Stable Angina
Keywords: Coronary heart disease
Stable angina
Traditional Chinese medicine
Xueshuanxinmaining tablet
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Stopping or reducing rate of antianginal drugs
timeFrame: Eight weeks after treatment
Secondary outcomes:
measure: Stopping or reducing rate of antianginal drugs
timeFrame: Two, four and eight weeks after treatment
measure: Changes of electrocardiogram (ECG)
timeFrame: Four and eight weeks after treatment
measure: Changes of Seattle Angina Questionnaire scores (SAQ scores)
timeFrame: Four and eight weeks after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Jun Li, MD
role: STUDY_DIRECTOR
References: