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

Phase 2

Completed

• Conditions: Hypertension
• Interventions: Drug: Placebo; Drug: Korean Red Ginseng Capsules

• Registration Number: NCT02211352
• Lead Sponsor: Daegu Catholic University Medical Center

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2013-05-01
• Primary Completion: 2013-12
• Study Completion: 2014-07
• Status Verified: 2014-08
• Study First Submitted QC: 2014-08-06
• Last Update Submitted: 2014-08-06
• Study First Posted: 2014-08-07
• Last Update Posted: 2014-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
central blood pressure change after treatment of Korea Red Ginseng	baseline, 8 weeks and 16 weeks after treatment

Secondary Outcome Measures

Name	Time	Method
CRP(C-reactive protein)	baseline, 8 week, 16 week.
ESR(erythrocyte sedmentation rate)	baseline, 8 week, 16 week.
Augumentation index	baseline, 8 week, 16 week.
brachial systolic and diastolic blood pressure	baseline, 8 week, 16 week.

Trial Locations

Locations (1)

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Korea, Republic of