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

NCT ID: NCT02211352

Last Updated: 2014-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active(Korean Red Ginseng) first group:

Korean Red Ginseng Capsules 2g,daily, 8 week and than crossover to placebo capsules(2g), daily 8week

Group Type ACTIVE_COMPARATOR

Korean Red Ginseng Capsules

Intervention Type DRUG

Korean Red Ginseng Capsules 2mg,daily, 8 week and than crossover to placebo capsules(2g), daily 8week

Placebo capsules

placebo Capsules(2g),daily, 8 week and than crossover to Korean Red Ginseng capsules(2g), daily 8week

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Korean Red Ginseng Capsules 2mg,daily, 8 week and than crossover to placebo capsules(2g), daily 8week

Interventions

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Korean Red Ginseng Capsules

Korean Red Ginseng Capsules 2mg,daily, 8 week and than crossover to placebo capsules(2g), daily 8week

Intervention Type DRUG

Placebo

Korean Red Ginseng Capsules 2mg,daily, 8 week and than crossover to placebo capsules(2g), daily 8week

Intervention Type DRUG

Other Intervention Names

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Korean Red Ginseng (KRG) Capsule was manufactured from roots of a 6-year-old Panax ginseng Meyer. Placebo of Kerea Red Ginseng(KRG) Capsule

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Korean Society of Ginseng

OTHER

Sponsor Role collaborator

Daegu Catholic University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jin Bae Lee

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin Bae Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Daegu Catholic University Medical Center

Locations

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Daegu Catholic University Medical Center

Daegu, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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GS302-100

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GS302-100

Identifier Type: -

Identifier Source: org_study_id

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