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

March 13, 2017 updated by: Jie Wang

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • Guang Anmen Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lipid
Time Frame: 60
Triacylglyceride,total cholesterol, low densith lipoprotein, high densith lipoprotein
60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jie Wang

Investigators

  • Principal Investigator: Jie Wang, Guang Anmen Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 20, 2017

Primary Completion (Anticipated)

April 20, 2017

Study Completion (Anticipated)

August 20, 2017

Study Registration Dates

First Submitted

March 13, 2017

First Submitted That Met QC Criteria

March 13, 2017

First Posted (Actual)

March 17, 2017

Study Record Updates

Last Update Posted (Actual)

March 17, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81473561

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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