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

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Heart Disease; Stable Angina
• Intervention / Treatment: Drug: Xueshuanxinmaining tablet; Drug: Nitroglycerin tablets; Drug: Xueshuanxinmaining placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jun Li, MD; Phone Number: +86 13051458913; Email: gamyylj@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Xueshuanxinmaining tablet; A kind of Chinese patent medicine; Other Names: XSXMN; Drug: Nitroglycerin tablets; Be used when angina attack
Placebo Comparator: 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.	Drug: Nitroglycerin tablets; Be used when angina attack; Drug: Xueshuanxinmaining placebo; The simulant of Xueshuanxinmaining tablet; Other Names: XSXMN placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Changes of electrocardiogram (ECG)	Mainly observe the ST segment and the change of T wave from the baseline	Four and eight weeks after treatment
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

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 11, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Coronary heart disease; Traditional Chinese medicine; Stable angina; Xueshuanxinmaining tablet
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Angina Pectoris; Angina, Stable; Vasodilator Agents; Nitroglycerin
• Other Study ID Numbers: XSXMN_2019001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No