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The Study of MicroRNA Genomics of Blood Stasis Syndrome and of Coronary Heart Disease

Primary Purpose

Coronary Heart Disease, Unstable Angina, Blood Stasis Syndrome

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Xuesaitong soft capsule
Xuesaitong soft capsule Placebo
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring MicroRNA, coronary heart disease, unstable angina, blood stasis syndrome, Xuesaitong soft capsule

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
  • Tongue dark
  • 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'an men HispitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Xuesaitong soft capsule group

control group

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

the change of Cycle threshold of relational microRNA in coronary artery disease with unstable angina
The change of Cycle threshold of relational microRNA in coronary artery disease with unstable angina by real RT-PCR.

Secondary Outcome Measures

Full Information

First Posted
May 28, 2012
Last Updated
January 12, 2014
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01615003
Brief Title
The Study of MicroRNA Genomics of Blood Stasis Syndrome and of Coronary Heart Disease
Official Title
The Analysis of Blood Stasis Syndromeand of Coronary Heart Disease Related MicroRNA Genomics and Target Gene Regulatory Networks
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study, typical cases of blood stasis syndrome of coronary heart disease are selected, by using microRNA chip, cDNA microarray and other bioinformatics technologies to filter and verify related miRNA and its target gene of Coronary Heart disease. Meanwhile, intervene by Xuesaitong soft capsules to investigate related miRNA and its target gene of 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, Blood Stasis Syndrome
Keywords
MicroRNA, coronary heart disease, unstable angina, blood stasis syndrome, Xuesaitong soft capsule

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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
control group
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
Xuesaitong soft capsule, soft capsule, Ingredients:PNS, Specification:0.33 per bag, once take two pills and twice a day during a month.
Intervention Type
Drug
Intervention Name(s)
Xuesaitong soft capsule Placebo
Intervention Description
Xuesaitong soft capsule Placebo, soft capsule, once take two pills and twice a day during a month.
Primary Outcome Measure Information:
Title
the change of Cycle threshold of relational microRNA in coronary artery disease with unstable angina
Description
The change of Cycle threshold of relational microRNA in coronary artery disease with unstable angina by real RT-PCR.
Time Frame
1 month

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 Tongue dark 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
Fei Teng, master
Phone
13581985462
Email
echo-teng@126.com
Facility Information:
Facility Name
Guang'an men Hispital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Teng, master
Phone
13581985462
Email
echo-teng@126.com
First Name & Middle Initial & Last Name & Degree
Gui Yu, master
Phone
13488835663
First Name & Middle Initial & Last Name & Degree
Jie Wang, doctor

12. IPD Sharing Statement

Learn more about this trial

The Study of MicroRNA Genomics of Blood Stasis Syndrome and of Coronary Heart Disease

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