Efficacy and Safety of Xuesaitong Soft Capsule for Coronary Heart Disease Unstable Angina

Phase 2

• Conditions: Coronary Heart Disease; Unstable Angina
• Interventions: Drug: Xuesaitong soft capsule; Drug: Placebo oral capsule

• Registration Number: NCT03083119
• Lead Sponsor: Jie Wang

Brief Summary

In this study, typical cases of coronary heart disease are selected. They will be intervened by Xuesaitong soft capsules to investigate efficacy and safety for Coronary Heart disease.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-03
• Study First Submitted: 2017-03-13
• Study First Submitted QC: 2017-03-13
• Last Update Submitted: 2017-03-13
• Study First Posted: 2017-03-17
• Last Update Posted: 2017-03-17
• Study Start: 2017-03-20
• Primary Completion: 2017-04-20
• Study Completion: 2017-08-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Clinical diagnosis of coronary angiography unstable angina
• Clinical diagnosis of unstable angina
• Age of 30 to 75 years old
• Not use thrombolysis, dilate coronary drugs within two weeks
• Sign the consent

Exclusion Criteria

• Severe valvular heart disease
• Insulin-dependent diabetes
• mental disease
• Combined with severe liver, kidney, hematopoietic system disorder
• Patients with malignant tumors
• Pregnancy or breast-feeding women
• Recent history of trauma
• Drug allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xuesaitong soft capsule group	Xuesaitong soft capsule	Patients who confirmed by coronary angiography and diagnosed blood stasis syndrome of coronary heart disease are given conventional Western medicine treatment and Xuesaitong soft capsule.
Placebo Comparator	Placebo oral capsule	Patients who confirmed by coronary angiography and diagnosed blood stasis syndrome of coronary heart disease are given conventional Western medicine treatment and placebo.

Primary Outcome Measures

Name	Time	Method
Seattle Angina Questionnaire	60 days	to evaluate patients by Seattle Angina Questionnaire
major adverse cardiovascular events	60 days	death, myocardial infarction, hospitalization for unstable angina or stroke
blood stasis syndrome scale of Coronary heart disease angina pectoris	60	to evaluate patients by blood stasis syndrome scale of Coronary heart disease angina pectoris

Secondary Outcome Measures

Name	Time	Method
lipid	60	Triacylglyceride,total cholesterol, low densith lipoprotein, high densith lipoprotein

Trial Locations

Locations (1)

Guang Anmen Hospital; 🇨🇳 Beijing, Beijing, China