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
  Purpose

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 Intervention Phase
Prehypertension
Hypertension, Stage I
Drug: Ginseol Kg1 (low dose)
Drug: Ginseol Kg1(high dose)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 90
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483430

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

Locations
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
Principal Investigator: Kwang-il Kim, MD, PhD Seoul National University Bundang Hospital
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Study First Received: November 29, 2011
Last Updated: November 30, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Blood pressure
Korea red ginseng
Ambulatory blood pressure
Pulse wave velocity

Additional relevant MeSH terms:
Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 16, 2014