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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03083119
Recruitment Status : Unknown
Verified March 2017 by Jie Wang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Recruitment status was:  Recruiting
First Posted : March 17, 2017
Last Update Posted : March 17, 2017
Sponsor:
Information provided by (Responsible Party):
Jie Wang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : March 20, 2017
Estimated Primary Completion Date : April 20, 2017
Estimated Study Completion Date : August 20, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. major adverse cardiovascular events [ Time Frame: 60 days ]
    death, myocardial infarction, hospitalization for unstable angina or stroke

  2. Seattle Angina Questionnaire [ Time Frame: 60 days ]
    to evaluate patients by Seattle Angina Questionnaire

  3. 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


Secondary Outcome Measures :
  1. lipid [ Time Frame: 60 ]
    Triacylglyceride,total cholesterol, low densith lipoprotein, high densith lipoprotein



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083119


Contacts
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Contact: Lian Duan +8601088001817 popale2003@163.com

Locations
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China, Beijing
Guang Anmen Hospital Recruiting
Beijing, Beijing, China, 100029
Contact: Lian Duan    +8601088001817    popale2003@163.com   
Sponsors and Collaborators
Jie Wang
Investigators
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Principal Investigator: Jie Wang Guang Anmen Hospital

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Responsible Party: Jie Wang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03083119     History of Changes
Other Study ID Numbers: 81473561
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Angina, Unstable
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms