Danshen Dropping Pill for Coronary Heart Disease Heart an... | NCT01825759

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

NCT01825759

Sponsor

West China Hospital

Status

Unknown status

Last Update Posted

Apr 8, 2013Estimated

Enrollment

200Estimated

Phase

Phase 4

Conditions

Coronary Heart Disease
Essential Hypertension

Interventions

danshen dripping pill

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Mar 26, 2013

First Submission Date that Met QC Criteria

Apr 5, 2013

First Posted Date

Apr 8, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2013

Last Update Posted Date

Apr 8, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiaoping Chen, Compound danshen dropping pill for coronary heart disease with hypertension patient heart and artery structure and function, West China HospitalPrincipal Investigator

Lead Sponsor

West China HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
danshen dripping pill	Experimental	danshen dripping pill 27mg ten pills by mouth every 8 hours for one year	Drug: danshen dripping pill

Interventions

Name	Type	Description	Arm Group Labels	Other Names
danshen dripping pill	Drug		danshen dripping pill	compound danshen dripping pill

Measure	Description	Time Frame
Pulse wave velocity		one year

Measure	Description	Time Frame
ankle-brachial index		one year

Measure	Description	Time Frame
intima-media thickness,methyl-di-aide-hyde		one year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:coronary heart disease，primary hypertension， -

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
chen xi ping, master	Contact	028-85423352		panpei74@163.com

Overall Officials

Name	Affiliation	Role
chen xi ping, master	organizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
West China Hospital	Recruiting	Chengdu	Sichuan		China

Label	URL
ABI	View source
IMT	View source

Condition Browse Module

MeSH Terms

ID	Term
D003327	Coronary Disease
D000075222	Essential Hypertension

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000604051	danshen dripping pill

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided