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

Coronary Heart Disease Clinical Trial

Official title:

The Methylation Regulation Mechanism of Blood Stasis Relevant miRNA Expression on Coronary Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03083119
• Other study ID #: 81473561
• Status: Recruiting
• Phase: Phase 2
• First received: March 13, 2017
• Last updated: March 13, 2017
• Start date: March 20, 2017
• Est. completion date: August 20, 2017

Study information

• Verified date: March 2017
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Lian Duan
• Phone: +8601088001817
• Email: popale2003[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 20, 2017
• Est. primary completion date: April 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Angina, Unstable
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia
• Unstable Angina

Intervention

Drug:
• Xuesaitong soft capsule
Panax Notoginseng Saponins, Specification:0.33 per bag, once take two pills and twice a day during a month.
• Placebo oral capsule
Xuesaitong soft capsule Placebo, soft capsule, once take two pills and twice a day during a month.

Locations

Country	Name	City	State
China	Guang Anmen Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jie Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major adverse cardiovascular events	death, myocardial infarction, hospitalization for unstable angina or stroke	60 days
Primary	Seattle Angina Questionnaire	to evaluate patients by Seattle Angina Questionnaire	60 days
Primary	blood stasis syndrome scale of Coronary heart disease angina pectoris	to evaluate patients by blood stasis syndrome scale of Coronary heart disease angina pectoris	60
Secondary	lipid	Triacylglyceride,total cholesterol, low densith lipoprotein, high densith lipoprotein	60