Clinical trial NCT02211352: Effect of Korean Red Ginseng on Central Blood Pressure in Patient With Essential Hypertension
Official title: Randomized Control Clinical Trial for Effect of Korean Red Ginseng on Central Blood Pressure in Patient With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Keywords: blood pressure, ginseng
Lead sponsor: Daegu Catholic University Medical Center
Sponsor class: OTHER
Collaborators: name: The Korean Society of Ginseng
First posted: 2014-08-07
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: central blood pressure change after treatment of Korea Red Ginseng
timeFrame: baseline, 8 weeks and 16 weeks after treatment
Secondary outcomes:
measure: brachial systolic and diastolic blood pressure
timeFrame: baseline, 8 week, 16 week.
measure: Augumentation index
timeFrame: baseline, 8 week, 16 week.
measure: ESR(erythrocyte sedmentation rate)
timeFrame: baseline, 8 week, 16 week.
measure: CRP(C-reactive protein)
timeFrame: baseline, 8 week, 16 week.
Other outcomes:
measure: AST(Aspartate Aminotransferase)
timeFrame: baseline, 8 week, 16 week
measure: Number of participants with adverse events
timeFrame: baseline, 8 week, 16 week
measure: fasting blood glucose
timeFrame: baseline, 8 week, 16 week
measure: Hb A1c(Hemoglobin A1c)
timeFrame: baseline, 8 week, 16 week
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
Study officials:
affiliation: Daegu Catholic University Medical Center
name: Jin Bae Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: