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NCT03083119 Clinical Trial

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
Secondary ID
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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