Effect of Ginseol Kg1 on Blood Pressure Lowering
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ClinicalTrials.gov Identifier: NCT01483430 |
Recruitment Status : Unknown
Verified November 2011 by Kwang-il Kim, Seoul National University Hospital.
Recruitment status was: Recruiting
First Posted : December 1, 2011
Last Update Posted : December 2, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prehypertension Hypertension, Stage I | Drug: Ginseol Kg1 (low dose) Drug: Ginseol Kg1(high dose) Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 90 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, 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 |
Study Start Date : | September 2011 |
Estimated Primary Completion Date : | June 2012 |
Estimated Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
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 |
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01483430
Contact: Kwang-il Kim, MD, PhD | +82-31-787-7032 | kikim907@snu.ac.kr |
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 |
Principal Investigator: | Kwang-il Kim, MD, PhD | Seoul National University Bundang Hospital |
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 |
First Posted: | December 1, 2011 Key Record Dates |
Last Update Posted: | December 2, 2011 |
Last Verified: | November 2011 |
Keywords provided by Kwang-il Kim, Seoul National University Hospital:
Blood pressure Korea red ginseng Ambulatory blood pressure Pulse wave velocity |
Additional relevant MeSH terms:
Prehypertension Vascular Diseases Cardiovascular Diseases |