Effect of Ginseol Kg1 on Blood Pressure Lowering

Prehypertension Clinical Trial

Official title:

Effect of Ginseol Kg1 on Blood Pressure Lowering in Prehypertensive or Stage I Hypertensive Patients: Multicenter, Randomized, Placebo-controlled, Double-blind Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01483430
• Other study ID #: CJ_Ginseol Kg1
• Status: Recruiting
• Phase: Phase 3
• First received: November 29, 2011
• Last updated: November 30, 2011
• Start date: September 2011
• Est. completion date: December 2012

Study information

• Verified date: November 2011
• Source: Seoul National University Hospital
• Contact: Kwang-il Kim, MD, PhD
• Phone: +82-31-787-7032
• Email: kikim907[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension, Stage I
• Prehypertension

Intervention

Drug:
• Ginseol Kg1 (low dose)
1 capsule/day (100mg of Ginseol Kg1), Duration: 8 weeks
• Ginseol Kg1(high dose)
1 capsule/day (300mg of Ginseol Kg1), Duration: 8 weeks
• Placebo
1 capsule/day (starch), Duration: 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	DongGuk University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference of the changes in office diastolic and systolic BP after 8 weeks' treatment between placebo and Ginseol Kg1 group		baseline and 8 week	Yes
Secondary	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.		baseline and 8 week	No
Secondary	The difference of the change in the brachial-ankle pulse wave velocity after 8 weeks' treatment between placebo and Ginseol Kg1 group.		baseline and 8 week	No
Secondary	The difference of the change in the hs-CRP after 8 weeks' treatment between placebo and Ginseol Kg1 group.		baseline and 8 week	No
Secondary	The difference of the change in the lipid profiles after 8 weeks' treatment between placebo and Ginseol Kg1 group		baseline and 8 week	No
Secondary	The difference of the changes in office diastolic and systolic BP after 4 weeks' treatment between placebo and Ginseol Kg1 group.		baseline and 4 week	Yes