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Completed

NCT Number: NCT02211352

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Daegu Catholic University Medical Center

Daegu, 705-718, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Korean Red Ginseng Capsules

Drug

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

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

Placebo

Drug

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

Other names: Placebo of Kerea Red Ginseng(KRG) Capsule

Primary outcomes

  1. central blood pressure change after treatment of Korea Red Ginseng

    Time frame: baseline, 8 weeks and 16 weeks after treatment

Secondary outcomes

  1. brachial systolic and diastolic blood pressure

    Time frame: baseline, 8 week, 16 week.

  2. Augumentation index

    Time frame: baseline, 8 week, 16 week.

  3. ESR(erythrocyte sedmentation rate)

    Time frame: baseline, 8 week, 16 week.

  4. CRP(C-reactive protein)

    Time frame: baseline, 8 week, 16 week.

Other outcomes

  1. AST(Aspartate Aminotransferase)

    Time frame: baseline, 8 week, 16 week

  2. Number of participants with adverse events

    Time frame: baseline, 8 week, 16 week

  3. fasting blood glucose

    Time frame: baseline, 8 week, 16 week

  4. Hb A1c(Hemoglobin A1c)

    Time frame: baseline, 8 week, 16 week

Sponsors and collaborators

Lead sponsor

Daegu Catholic University Medical Center

Other

Collaborators

  • The Korean Society of Ginseng

Registry information

Official study title

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

Acronym: KRGCBP

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Aug 7, 2014
Registry last updated
Aug 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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