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

Primary Purpose

Coronary Heart Disease, Unstable Angina

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Xuesaitong soft capsule
Placebo oral capsule
Sponsored by
Jie Wang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Guang Anmen HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Xuesaitong soft capsule group

Placebo Comparator

Arm Description

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.

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

Outcomes

Primary Outcome Measures

major adverse cardiovascular events
death, myocardial infarction, hospitalization for unstable angina or stroke
Seattle Angina Questionnaire
to evaluate patients by Seattle Angina Questionnaire
blood stasis syndrome scale of Coronary heart disease angina pectoris
to evaluate patients by blood stasis syndrome scale of Coronary heart disease angina pectoris

Secondary Outcome Measures

lipid
Triacylglyceride,total cholesterol, low densith lipoprotein, high densith lipoprotein

Full Information

First Posted
March 13, 2017
Last Updated
March 13, 2017
Sponsor
Jie Wang
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1. Study Identification

Unique Protocol Identification Number
NCT03083119
Brief Title
Efficacy and Safety of Xuesaitong Soft Capsule for Coronary Heart Disease Unstable Angina
Official Title
The Methylation Regulation Mechanism of Blood Stasis Relevant miRNA Expression on Coronary Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2017 (Anticipated)
Primary Completion Date
April 20, 2017 (Anticipated)
Study Completion Date
August 20, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jie Wang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Unstable Angina

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Xuesaitong soft capsule group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Patients who confirmed by coronary angiography and diagnosed blood stasis syndrome of coronary heart disease are given conventional Western medicine treatment and placebo.
Intervention Type
Drug
Intervention Name(s)
Xuesaitong soft capsule
Intervention Description
Panax Notoginseng Saponins, Specification:0.33 per bag, once take two pills and twice a day during a month.
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Xuesaitong soft capsule Placebo, soft capsule, once take two pills and twice a day during a month.
Primary Outcome Measure Information:
Title
major adverse cardiovascular events
Description
death, myocardial infarction, hospitalization for unstable angina or stroke
Time Frame
60 days
Title
Seattle Angina Questionnaire
Description
to evaluate patients by Seattle Angina Questionnaire
Time Frame
60 days
Title
blood stasis syndrome scale of Coronary heart disease angina pectoris
Description
to evaluate patients by blood stasis syndrome scale of Coronary heart disease angina pectoris
Time Frame
60
Secondary Outcome Measure Information:
Title
lipid
Description
Triacylglyceride,total cholesterol, low densith lipoprotein, high densith lipoprotein
Time Frame
60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lian Duan
Phone
+8601088001817
Email
popale2003@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Wang
Organizational Affiliation
Guang Anmen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guang Anmen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lian Duan
Phone
+8601088001817
Email
popale2003@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35784716
Citation
Duan L, Liu Y, Li J, Zhang Y, Dong Y, Liu C, Wang J. Panax notoginseng Saponins Alleviate Coronary Artery Disease Through Hypermethylation of the miR-194-MAPK Pathway. Front Pharmacol. 2022 Jun 16;13:829416. doi: 10.3389/fphar.2022.829416. eCollection 2022.
Results Reference
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Efficacy and Safety of Xuesaitong Soft Capsule for Coronary Heart Disease Unstable Angina

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