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Effect of Ginseol Kg1 on Blood Pressure Lowering

NCT ID: NCT01483430

Last Updated: 2011-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-12-31

Brief Summary

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

Detailed Description

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This is a multicenter, randomized, placebo-controlled, double-blind study. At the end of an initial 2-week washout period, patients fulfilling the inclusion criteria are assigned to three groups, i.e. control group (placebo), low dose Ginseol Kg1 group (100mg), or high dose Ginseol Kg1 (300mg) group. They will intake the study drug for 8 weeks. 24-h ambulatory BP monitoring (ABPM) and pulse wave velocity are measured at the end of the washout period and after 8 weeks of active treatment. At each visit, seated SBP and DBP, heart rate, use of concomitant medication and spontaneously reported adverse events are recorded. Compliance with medication (determined by counting returned tablets) is evaluated at each visit.

Conditions

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Prehypertension Hypertension, Stage I

Keywords

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Blood pressure Korea red ginseng Ambulatory blood pressure Pulse wave velocity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Ginseol Kg1, high dose

Group Type EXPERIMENTAL

Ginseol Kg1(high dose)

Intervention Type DRUG

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

Ginseol Kg1, low dose

Group Type EXPERIMENTAL

Ginseol Kg1 (low dose)

Intervention Type DRUG

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

Interventions

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Ginseol Kg1 (low dose)

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

Intervention Type DRUG

Ginseol Kg1(high dose)

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DongGuk University

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kwang-il Kim

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kwang-il Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Kwang-il Kim, MD, PhD

Role: CONTACT

Phone: +82-31-787-7032

Email: [email protected]

Facility Contacts

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Kwang-il Kim, MD, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 24871654 (View on PubMed)

Other Identifiers

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CJ_Ginseol Kg1

Identifier Type: -

Identifier Source: org_study_id