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

Daegu Catholic University Medical Center

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: Placebo; Drug: Korean Red Ginseng Capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT02211352

GS302-100 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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58 participants in 2 patient groups, including a placebo group

Active(Korean Red Ginseng) first group:

Active Comparator group

Description:

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

Treatment:

Drug: Korean Red Ginseng Capsules

Placebo capsules

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo