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

Sponsor

Jie Wang (Other)

Overall Status

Unknown status

CT.gov ID

NCT03083119

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

13.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease Unstable Angina	Drug: Xuesaitong soft capsule Drug: Placebo oral capsule	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 20, 2017

Anticipated Primary Completion Date :

Apr 20, 2017

Anticipated Study Completion Date :

Aug 20, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Xuesaitong soft capsule group 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.	Drug: Xuesaitong soft capsule Panax Notoginseng Saponins, Specification:0.33 per bag, once take two pills and twice a day during a month.
Placebo Comparator: Placebo Comparator Patients who confirmed by coronary angiography and diagnosed blood stasis syndrome of coronary heart disease are given conventional Western medicine treatment and placebo.	Drug: Placebo oral capsule Xuesaitong soft capsule Placebo, soft capsule, once take two pills and twice a day during a month.

Arm

Intervention/Treatment

Experimental: Xuesaitong soft capsule group

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.

Drug: Xuesaitong soft capsule

Panax Notoginseng Saponins, Specification:0.33 per bag, once take two pills and twice a day during a month.

Placebo Comparator: Placebo Comparator

Patients who confirmed by coronary angiography and diagnosed blood stasis syndrome of coronary heart disease are given conventional Western medicine treatment and placebo.

Drug: Placebo oral capsule

Xuesaitong soft capsule Placebo, soft capsule, once take two pills and twice a day during a month.

Outcome Measures

Primary Outcome Measures

major adverse cardiovascular events [60 days]
death, myocardial infarction, hospitalization for unstable angina or stroke
Seattle Angina Questionnaire [60 days]
to evaluate patients by Seattle Angina Questionnaire
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

lipid [60]
Triacylglyceride,total cholesterol, low densith lipoprotein, high densith lipoprotein

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guang Anmen Hospital	Beijing	Beijing	China	100029

Sponsors and Collaborators

Jie Wang

Investigators

Principal Investigator: Jie Wang, Guang Anmen Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jie Wang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

ClinicalTrials.gov Identifier:

NCT03083119

Other Study ID Numbers:

81473561

First Posted:

Mar 17, 2017

Last Update Posted:

Mar 17, 2017

Last Verified:

Mar 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Diseases

Coronary Disease

Coronary Artery Disease

Myocardial Ischemia

Angina, Unstable

Study Results

No Results Posted as of Mar 17, 2017