NCT02326766

Brief Summary

This study evaluated effects of red ginseng consumption on blood pressure (BP) and fasting plasma metabolomes.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 29, 2014

Completed
Last Updated

December 29, 2014

Status Verified

December 1, 2014

Enrollment Period

3 months

First QC Date

December 22, 2014

Last Update Submit

December 26, 2014

Conditions

Prehypertension

Outcome Measures

Primary Outcomes (1)

  • changes from baselilne in blood pressure

    12 week

Secondary Outcomes (1)

  • changes from baseline in plasma metabolites

    12 week

Study Arms (2)

KRG

EXPERIMENTAL

5g Korea red ginseng (KRG)

Dietary Supplement: KRG

Placebo

PLACEBO COMPARATOR

5 g placebo (corn starch)

Dietary Supplement: Placebo

Interventions

KRGDIETARY_SUPPLEMENT

5g Korea red ginseng (KRG)

KRG
PlaceboDIETARY_SUPPLEMENT

5g placebo

Placebo

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • nondiabetic, nonobese and prehypertensive subjects with blood pressures ranging 120 - 139 mmHg (systolic) or 80-89 mmHg (diastolic) were enrolled in this study.

You may not qualify if:

  • self-reported use of antihypertensive medication
  • abnormal liver or renal function
  • history of cardiovascular disease
  • kidney disease
  • cancer
  • thyroid or pituitary disease or any other serious life-threatening illness that required regular medical treatment
  • we also excluded women who were pregnant, breast feeding or intending to become pregnant during the time of study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cha TW, Kim M, Kim M, Chae JS, Lee JH. Blood pressure-lowering effect of Korean red ginseng associated with decreased circulating Lp-PLA2 activity and lysophosphatidylcholines and increased dihydrobiopterin level in prehypertensive subjects. Hypertens Res. 2016 Jun;39(6):449-56. doi: 10.1038/hr.2016.7. Epub 2016 Feb 4.

    PMID: 26843120DERIVED

MeSH Terms

Conditions

Prehypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2014

First Posted

December 29, 2014

Study Start

November 1, 2011

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

December 29, 2014

Record last verified: 2014-12