Effect of Ginseol Kg1 on Blood Pressure Lowering
This study is currently recruiting participants.
Verified November 2011 by Seoul National University Hospital
Sponsor:
Seoul National University Hospital
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
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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
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
| 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 June 13, 2013