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

Study Overview
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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.

Official Title
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Randomized Control Clinical Trial for Effect of Korean Red Ginseng on Central Blood Pressure in Patient With Essential Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Korean Red Ginseng Capsules
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active(Korean Red Ginseng) first group:<br>Korean Red Ginseng Capsules 2g,daily, 8 week and than crossover to placebo capsules(2g), daily 8week | Drug: Korean Red Ginseng Capsules<br>* Korean Red Ginseng Capsules 2mg,daily, 8 week and than crossover to placebo capsules(2g), daily 8week<br>* Other names: from roots of a 6-year-old Panax ginseng Meyer.;|
| Placebo Comparator: Placebo capsules<br>placebo Capsules(2g),daily, 8 week and than crossover to Korean Red Ginseng capsules(2g), daily 8week | Drug: Placebo<br>* Korean Red Ginseng Capsules 2mg,daily, 8 week and than crossover to placebo capsules(2g), daily 8week<br>* Other names: Placebo of Kerea Red Ginseng(KRG) Capsule;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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) |  | baseline, 8 week, 16 week. | 
| CRP(C-reactive protein) |  | baseline, 8 week, 16 week. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood pressure, ginseng