- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02211352
Effect of Korean Red Ginseng on Central Blood Pressure in Patient With Essential Hypertension (KRGCBP)
Randomized Control Clinical Trial for Effect of Korean Red Ginseng on Central Blood Pressure in Patient With Essential Hypertension
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Daegu, Korea, Republic of, 705-718
- Daegu Catholic University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active(Korean Red Ginseng) first group:
Korean Red Ginseng Capsules 2g,daily, 8 week and than crossover to placebo capsules(2g), daily 8week
|
Korean Red Ginseng Capsules 2mg,daily, 8 week and than crossover to placebo capsules(2g), daily 8week
Other Names:
|
Placebo Comparator: Placebo capsules
placebo Capsules(2g),daily, 8 week and than crossover to Korean Red Ginseng capsules(2g), daily 8week
|
Korean Red Ginseng Capsules 2mg,daily, 8 week and than crossover to placebo capsules(2g), daily 8week
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
central blood pressure change after treatment of Korea Red Ginseng
Time Frame: baseline, 8 weeks and 16 weeks after treatment
|
baseline, 8 weeks and 16 weeks after treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
brachial systolic and diastolic blood pressure
Time Frame: baseline, 8 week, 16 week.
|
baseline, 8 week, 16 week.
|
Augumentation index
Time Frame: baseline, 8 week, 16 week.
|
baseline, 8 week, 16 week.
|
ESR(erythrocyte sedmentation rate)
Time Frame: baseline, 8 week, 16 week.
|
baseline, 8 week, 16 week.
|
CRP(C-reactive protein)
Time Frame: baseline, 8 week, 16 week.
|
baseline, 8 week, 16 week.
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AST(Aspartate Aminotransferase)
Time Frame: baseline, 8 week, 16 week
|
baseline, 8 week, 16 week
|
Number of participants with adverse events
Time Frame: baseline, 8 week, 16 week
|
baseline, 8 week, 16 week
|
fasting blood glucose
Time Frame: baseline, 8 week, 16 week
|
baseline, 8 week, 16 week
|
Hb A1c(Hemoglobin A1c)
Time Frame: baseline, 8 week, 16 week
|
baseline, 8 week, 16 week
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jin Bae Lee, MD, PhD, Daegu Catholic University Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GS302-100 (Other Grant/Funding Number: GS302-100)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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