NCT01483430

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prehypertension
• Hypertension, Stage I

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-06-01
• Completion: 2012-12-01
• First posted: 2011-12-01
• Last updated: 2011-12-02

Locations

1 site across 1 country: South Korea