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

NCT02211352 | Completed Phase 2 DMC

• 1 other identifier: GS302-100
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Keywords

blood pressure, ginseng

Outcome Measures

Primary Outcomes (1)

• central blood pressure change after treatment of Korea Red Ginseng

  baseline, 8 weeks and 16 weeks after treatment

Secondary Outcomes (4)

• 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.

Other Outcomes (4)

• AST(Aspartate Aminotransferase)

  baseline, 8 week, 16 week

• Number of participants with adverse events

  baseline, 8 week, 16 week

• fasting blood glucose

  baseline, 8 week, 16 week

Study Arms (2)

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

Korean Red Ginseng Capsules DRUG

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

Also known as: Korean Red Ginseng (KRG) Capsule was manufactured, from roots of a 6-year-old Panax ginseng Meyer.

Active(Korean Red Ginseng) first group:

Placebo DRUG

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

Also known as: Placebo of Kerea Red Ginseng(KRG) Capsule

Placebo capsules

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daegu Catholic University Medical Center: lead
• The Korean Society of Ginseng: collaborator

Study Sites (1)

Daegu Catholic University Medical Center

Daegu, 705-718, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

Asian ginseng; Capsules

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Jin Bae Lee, MD, PhD

  Daegu Catholic University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: August 7, 2014
• Study Start: May 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: July 1, 2014
• Last Updated: August 7, 2014

Record last verified: 2014-08

Locations

KR (1)