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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

Tracking Information
First Submitted Date  ICMJE November 29, 2011
First Posted Date  ICMJE December 1, 2011
Last Update Posted Date December 2, 2011
Study Start Date  ICMJE September 2011
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2011)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 29, 2011)
The difference of the changes in office diastolic and systolic BP after 8 weeks' treatment between placebo and Ginseol Kg1 group [ Time Frame: 0, 8 week ]
Change History Complete list of historical versions of study NCT01483430 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2011)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2011)
  • 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: 0, 8 week ]
  • The difference of the change in the brachial-ankle pulse wave velocity after 8 weeks' treatment between placebo and Ginseol Kg1 group. [ Time Frame: 0, 8 week ]
  • The difference of the change in the hs-CRP after 8 weeks' treatment between placebo and Ginseol Kg1 group. [ Time Frame: 0, 8 week ]
  • The difference of the change in the lipid profiles after 8 weeks' treatment between placebo and Ginseol Kg1 group [ Time Frame: 0, 8 week ]
  • The difference of the changes in office diastolic and systolic BP after 4 weeks' treatment between placebo and Ginseol Kg1 group. [ Time Frame: 0, 4 week ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Ginseol Kg1 on Blood Pressure Lowering
Official Title  ICMJE Effect of Ginseol Kg1 on Blood Pressure Lowering in Prehypertensive or Stage I Hypertensive Patients: Multicenter, Randomized, Placebo-controlled, Double-blind Study
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.
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 Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Prehypertension
  • Hypertension, Stage I
Intervention  ICMJE
  • Drug: Ginseol Kg1 (low dose)
    1 capsule/day (100mg of Ginseol Kg1), Duration: 8 weeks
  • Drug: Ginseol Kg1(high dose)
    1 capsule/day (300mg of Ginseol Kg1), Duration: 8 weeks
  • Drug: Placebo
    1 capsule/day (starch), Duration: 8 weeks
Study Arms
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Ginseol Kg1, high dose
    Intervention: Drug: Ginseol Kg1(high dose)
  • Experimental: Ginseol Kg1, low dose
    Intervention: Drug: Ginseol Kg1 (low dose)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 29, 2011)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date December 2012
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01483430
Other Study ID Numbers  ICMJE CJ_Ginseol Kg1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Kwang-il Kim, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE DongGuk University
Investigators  ICMJE
Principal Investigator: Kwang-il Kim, MD, PhD Seoul National University Bundang Hospital
PRS Account Seoul National University Hospital
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP