Effect of Korean Red Ginseng on Central Blood Pressure in... | NCT02211352

Studies
Effect of Korean Red Ginseng on Central Blood Pressure in Patient With Essential Hypertension

NCT02211352

Sponsor

Daegu Catholic University Medical Center

Status

Completed

Last Update Posted

Aug 7, 2014Estimated

Enrollment

58Actual

Phase

Phase 2

Conditions

Hypertension

Interventions

Korean Red Ginseng Capsules
Placebo

Countries

South Korea

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

ID	Type	Description	Link
GS302-100	Other Grant/Funding Number	GS302-100

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Jul 2014Actual

First Submitted Date

May 1, 2013

First Submission Date that Met QC Criteria

Aug 6, 2014

First Posted Date

Aug 7, 2014Estimated

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

Aug 6, 2014

Last Update Posted Date

Aug 7, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jin Bae Lee, Associate professor, Daegu Catholic University Medical CenterPrincipal Investigator

Lead Sponsor

Daegu Catholic University Medical CenterOTHER

Collaborators

Name	Class
The Korean Society of Ginseng	OTHER

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 purpose of this study is to determine Korean red ginseng (KRG)treatment could decrease central blood pressure in subjects with hypertension.

Detailed Description

Participants with hypertension who were treated with antihypertensive agents were randomly assigned to an active (KRG 2 g/day) or a placebo treatment group in a double-blind cross over manner.

Participants were not allowed to change their antihypertensive medications except safety issue. Brachial systolic BP (SBP), diastolic BP (DBP), Central SBP and DBP will measured at baseline,at 2 and 4 months.

Efficacy and safety data will be monitored by Daegu Catholic University Medical Center Institutional Review Board and reported to the Korean Ginseng Society.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active(Korean Red Ginseng) first group:	Active Comparator	Korean Red Ginseng Capsules 2g,daily, 8 week and than crossover to placebo capsules(2g), daily 8week	Drug: Korean Red Ginseng Capsules
Placebo capsules	Placebo Comparator	placebo Capsules(2g),daily, 8 week and than crossover to Korean Red Ginseng capsules(2g), daily 8week	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Korean Red Ginseng Capsules	Drug	Korean Red Ginseng Capsules 2mg,daily, 8 week and than crossover to placebo capsules(2g), daily 8week	Active(Korean Red Ginseng) first group:

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
central blood pressure change after treatment of Korea Red Ginseng		baseline, 8 weeks and 16 weeks after treatment

Secondary Outcomes

Measure	Description	Time Frame
brachial systolic and diastolic blood pressure		baseline, 8 week, 16 week.
Augumentation index		baseline, 8 week, 16 week.
ESR(erythrocyte sedmentation rate)

Other Outcomes

Measure	Description	Time Frame
AST(Aspartate Aminotransferase)		baseline, 8 week, 16 week
Number of participants with adverse events		baseline, 8 week, 16 week
fasting blood glucose

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Essential hypertension
diastolic blood pressure 100 mmHg or less and systolic blood pressure 160 mmHg or less

Exclusion Criteria:

Secondary hypertension
Serum creatinin above 1.5 mg/dL
aspartate aminotransferase(AST) and alanine aminotransferaseALT above two times upper normal limits
Uncontrolled diabetes (Hb A1c < 9%)
Acute myocardial infarction or coronary artery disease intervention within six months
Moderate to severe congestive heart failure
HIV positive
Immunocompromized host
Allergy to Korean red ginseng
Pregnancy or plan to pregnancy
Alcohol or drug abuse
Attend to other clinical trial within 12 weeks

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jin Bae Lee, MD, PhD	Daegu Catholic University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Daegu Catholic University Medical Center		Daegu		705-718	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000713447	Asian ginseng
D002214	Capsules

Ancestor Terms

ID	Term
D004304	Dosage Forms
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided