NCT01483430

Brief Summary

In this study, we investigate the effects of Ginseol Kg1 (Korea red ginseng extract) on blood pressure in prehypertensive or stage I hypertensive patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 2, 2011

Status Verified

November 1, 2011

Enrollment Period

9 months

First QC Date

November 29, 2011

Last Update Submit

November 30, 2011

Conditions

PrehypertensionHypertension, Stage I

Keywords

Blood pressureKorea red ginsengAmbulatory blood pressurePulse wave velocity

Outcome Measures

Primary Outcomes (1)

  • The difference of the changes in office diastolic and systolic BP after 8 weeks' treatment between placebo and Ginseol Kg1 group

    baseline and 8 week

Secondary Outcomes (5)

  • The difference of the changes in the mean 24-hour ambulatory systolic and diastolic BP after 8 weeks' treatment between placebo and Ginseol Kg1 group.

    baseline and 8 week

  • The difference of the change in the brachial-ankle pulse wave velocity after 8 weeks' treatment between placebo and Ginseol Kg1 group.

    baseline and 8 week

  • The difference of the change in the hs-CRP after 8 weeks' treatment between placebo and Ginseol Kg1 group.

    baseline and 8 week

  • The difference of the change in the lipid profiles after 8 weeks' treatment between placebo and Ginseol Kg1 group

    baseline and 8 week

  • The difference of the changes in office diastolic and systolic BP after 4 weeks' treatment between placebo and Ginseol Kg1 group.

    baseline and 4 week

Study Arms (3)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Ginseol Kg1, high dose

EXPERIMENTAL
Drug: Ginseol Kg1(high dose)

Ginseol Kg1, low dose

EXPERIMENTAL
Drug: Ginseol Kg1 (low dose)

Interventions

Ginseol Kg1 (low dose)DRUG

1 capsule/day (100mg of Ginseol Kg1), Duration: 8 weeks

Ginseol Kg1, low dose
Ginseol Kg1(high dose)DRUG

1 capsule/day (300mg of Ginseol Kg1), Duration: 8 weeks

Ginseol Kg1, high dose
PlaceboDRUG

1 capsule/day (starch), Duration: 8 weeks

Placebo

Eligibility Criteria

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

You may qualify if:

  • Age: Adults over 20 years
  • Prehypertension or stage 1 hypertension (systolic blood pressure 120\~159mmHg or diastolic blood pressure 80\~99mmHg)
  • Subject who has not taken medications to treat hypertension within 15 days prior to first visit

You may not qualify if:

  • Subject who has been involved in other clinical trials within 30 days prior to first visit
  • Subject who has following diseases within 2 years prior to screening: angina pectoris, myocardial infarction, heart failure, peripheral vascular disease, chronic liver failure, chronic renal failure, diabetes mellitus, hyperthyroidism, hypothyroidism, malignant tumor, mental disease
  • Systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥ 100 mmHg during screening period
  • Subject who has hepatic dysfunction(AST, ALT ≥ 2.5 times higher than normal value)
  • Subject who has renal dysfunction(creatinine ≥ 1.5 times higher than normal value)
  • Subject who is pregnant or breast feeding
  • Alcoholic
  • Subject who has an allergy to the ingredients of study product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

Related Publications (1)

  • Rhee MY, Cho B, Kim KI, Kim J, Kim MK, Lee EK, Kim HJ, Kim CH. Blood pressure lowering effect of Korea ginseng derived ginseol K-g1. Am J Chin Med. 2014;42(3):605-18. doi: 10.1142/S0192415X14500396.

    PMID: 24871654DERIVED

MeSH Terms

Conditions

PrehypertensionHypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Kwang-il Kim, MD, PhD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kwang-il Kim, MD, PhD

CONTACT

+82-31-787-7032kikim907@snu.ac.kr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 29, 2011

First Posted

December 1, 2011

Study Start

September 1, 2011

Primary Completion

June 1, 2012

Study Completion

December 1, 2012

Last Updated

December 2, 2011

Record last verified: 2011-11

Locations

KR(1)