Efficacy and Safety of Xueshuanxinmaining Tablet for the Treatment of Stable Angina Pectoris

Coronary Heart Disease Clinical Trial

Official title:

Efficacy and Safety of Xueshuanxinmaining Tablet for the Treatment of Stable Angina Pectoris: Multicenter, Randomised, Double Blind, Placebo Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04270279
• Other study ID #: XSXMN_2019001
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 2020
• Est. completion date: October 2021

Study information

• Verified date: November 2020
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Jun Li, MD
• Phone: +86 13051458913
• Email: gamyylj[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: October 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia
• Stable Angina

Intervention

Drug:
• Xueshuanxinmaining tablet
A kind of Chinese patent medicine
• Xueshuanxinmaining placebo
The simulant of Xueshuanxinmaining tablet
• Nitroglycerin tablets
Be used when angina attack

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stopping or reducing rate of antianginal drugs	Antianginal drugs include nitroglycerin tablet, compound Danshen dropping pill and Suxiao Jiuxin pill.	Eight weeks after treatment
Secondary	Stopping or reducing rate of antianginal drugs	Antianginal drugs include nitroglycerin tablet, compound Danshen dropping pill and Suxiao Jiuxin pill.	Two, four and eight weeks after treatment
Secondary	Changes of electrocardiogram (ECG)	Mainly observe the ST segment and the change of T wave from the baseline	Four and eight weeks after treatment
Secondary	Changes of Seattle Angina Questionnaire scores (SAQ scores)	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.	Four and eight weeks after treatment