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Danshen Dropping Pill for Coronary Heart Disease Heart and Artery Structure and Function

Primary Purpose

Coronary Heart Disease, Essential Hypertension

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
danshen dripping pill
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:coronary heart disease，primary hypertension， -

Exclusion Criteria:secondary hypertension，diabetes mellitus，chronic renal disease，cardiac insufficiency

-

Sites / Locations

  • West China HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

danshen dripping pill

Arm Description

danshen dripping pill 27mg ten pills by mouth every 8 hours for one year

Outcomes

Primary Outcome Measures

Pulse wave velocity

Secondary Outcome Measures

ankle-brachial index

Full Information

First Posted
March 26, 2013
Last Updated
April 5, 2013
Sponsor
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01825759
Brief Title
Danshen Dropping Pill for Coronary Heart Disease Heart and Artery Structure and Function
Official Title
The Impact of Compound Danshen Dropping Pill for Coronary Heart Disease With Hypertension Patient Heart and Artery Structure and Function
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The Impact of Compound danshen dropping pill for coronary heart disease (CHD) heart and artery structure and function in patients with hypertension
Detailed Description
Compound danshen dropping pill for coronary heart disease (CHD) heart and artery structure and function in patients with hypertension.We can accorand the pwv ,IMT and MDA to assess the impact of heart and artery structure and function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Essential Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
danshen dripping pill
Arm Type
Experimental
Arm Description
danshen dripping pill 27mg ten pills by mouth every 8 hours for one year
Intervention Type
Drug
Intervention Name(s)
danshen dripping pill
Other Intervention Name(s)
compound danshen dripping pill
Primary Outcome Measure Information:
Title
Pulse wave velocity
Time Frame
one year
Secondary Outcome Measure Information:
Title
ankle-brachial index
Time Frame
one year
Other Pre-specified Outcome Measures:
Title
intima-media thickness,methyl-di-aide-hyde
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:coronary heart disease，primary hypertension， - Exclusion Criteria:secondary hypertension，diabetes mellitus，chronic renal disease，cardiac insufficiency -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
chen xi ping, master
Phone
028-85423352
Email
panpei74@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
chen xi ping, master
Organizational Affiliation
organizer
Official's Role
Study Director
Facility Information:
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
chen xi ping, master
Phone
028-85423352
Email
panpei74@163.com

12. IPD Sharing Statement

Links:
URL
http://ClinicalTrials.gov
Description
ABI
URL
http://ClinicalTrials.gov
Description
IMT

Learn more about this trial

Danshen Dropping Pill for Coronary Heart Disease Heart and Artery Structure and Function

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