Effect of Ginseol Kg1 on Blood Pressure Lowering

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
DongGuk University
Information provided by (Responsible Party):
Kwang-il Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01483430
First received: November 29, 2011
Last updated: November 30, 2011
Last verified: November 2011

November 29, 2011
November 30, 2011
September 2011
June 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01483430 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The difference of the change in the hs-CRP after 8 weeks' treatment between placebo and Ginseol Kg1 group. [ Time Frame: 0, 8 week ] [ Designated as safety issue: No ]
  • The difference of the change in the lipid profiles after 8 weeks' treatment between placebo and Ginseol Kg1 group [ Time Frame: 0, 8 week ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Effect of Ginseol Kg1 on Blood Pressure Lowering
Effect of Ginseol Kg1 on Blood Pressure Lowering in Prehypertensive or Stage I Hypertensive Patients: Multicenter, Randomized, Placebo-controlled, Double-blind Study

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Prehypertension
  • Hypertension, Stage I
  • 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
  • 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)
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.
 
Recruiting
90
December 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact: Kwang-il Kim, MD, PhD +82-31-787-7032 kikim907@snu.ac.kr
Korea, Republic of
 
NCT01483430
CJ_Ginseol Kg1
No
Kwang-il Kim, Seoul National University Hospital
Seoul National University Hospital
DongGuk University
Principal Investigator: Kwang-il Kim, MD, PhD Seoul National University Bundang Hospital
Seoul National University Hospital
November 2011

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