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Effect of Ginseol Kg1 on Blood Pressure Lowering

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ClinicalTrials.gov Identifier: NCT01483430
Recruitment Status : Unknown
Verified November 2011 by Kwang-il Kim, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : December 1, 2011
Last Update Posted : December 2, 2011
Sponsor:
Collaborator:
DongGuk University
Information provided by (Responsible Party):
Kwang-il Kim, Seoul National University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prehypertension Hypertension, Stage I Drug: Ginseol Kg1 (low dose) Drug: Ginseol Kg1(high dose) Drug: Placebo Phase 3

Detailed Description:
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Ginseol Kg1 on Blood Pressure Lowering in Prehypertensive or Stage I Hypertensive Patients: Multicenter, Randomized, Placebo-controlled, Double-blind Study
Study Start Date : September 2011
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : December 2012

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
1 capsule/day (starch), Duration: 8 weeks
Experimental: Ginseol Kg1, high dose Drug: Ginseol Kg1(high dose)
1 capsule/day (300mg of Ginseol Kg1), Duration: 8 weeks
Experimental: Ginseol Kg1, low dose Drug: Ginseol Kg1 (low dose)
1 capsule/day (100mg of Ginseol Kg1), Duration: 8 weeks


Outcome Measures
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Primary Outcome Measures :
  1. The difference of the changes in office diastolic and systolic BP after 8 weeks' treatment between placebo and Ginseol Kg1 group [ Time Frame: baseline and 8 week ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: baseline and 8 week ]
  2. The difference of the change in the brachial-ankle pulse wave velocity after 8 weeks' treatment between placebo and Ginseol Kg1 group. [ Time Frame: baseline and 8 week ]
  3. The difference of the change in the hs-CRP after 8 weeks' treatment between placebo and Ginseol Kg1 group. [ Time Frame: baseline and 8 week ]
  4. The difference of the change in the lipid profiles after 8 weeks' treatment between placebo and Ginseol Kg1 group [ Time Frame: baseline and 8 week ]
  5. The difference of the changes in office diastolic and systolic BP after 4 weeks' treatment between placebo and Ginseol Kg1 group. [ Time Frame: baseline and 4 week ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01483430


Contacts
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Contact: Kwang-il Kim, MD, PhD +82-31-787-7032 kikim907@snu.ac.kr

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Kwang-il Kim, MD, PhD    +82-31-787-7032    kikim907@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
DongGuk University
Investigators
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Principal Investigator: Kwang-il Kim, MD, PhD Seoul National University Bundang Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kwang-il Kim, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01483430     History of Changes
Other Study ID Numbers: CJ_Ginseol Kg1
First Posted: December 1, 2011    Key Record Dates
Last Update Posted: December 2, 2011
Last Verified: November 2011

Keywords provided by Kwang-il Kim, Seoul National University Hospital:
Blood pressure
Korea red ginseng
Ambulatory blood pressure
Pulse wave velocity

Additional relevant MeSH terms:
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Prehypertension
Vascular Diseases
Cardiovascular Diseases