PrehypertensionPhase 3NCT01483430
Effect of Ginseol Kg1 on Blood Pressure Lowering
A Phase 3 study testing Ginseol Kg1 (low dose) and Ginseol Kg1(high dose) in people with Prehypertension and Hypertension, Stage I, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Prehypertension, Hypertension, Stage I
- What is being tested?
- Ginseol Kg1 (low dose) and Ginseol Kg1(high dose)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2011to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Kwang-il Kim, MD, PhD, +82-31-787-7032, kikim907@snu.ac.kr
About this study
Official title: Effect of Ginseol Kg1 on Blood Pressure Lowering in Prehypertensive or Stage I Hypertensive Patients: Multicenter, Randomized, Placebo-controlled, Double-blind Study
In this study, we investigate the effects of Ginseol Kg1 (Korea red ginseng extract) on blood pressure in prehypertensive or stage I hypertensive patients.
Read the 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
- Being tested
- Ginseol Kg1 (low dose), Ginseol Kg1(high dose), Placebo
- Keywords
- Blood pressure, Korea red ginseng, Ambulatory blood pressure, Pulse wave velocity
- Medical subject headings
- Prehypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginseol Kg1 (low dose)Drug
1 capsule/day (100mg of Ginseol Kg1), Duration: 8 weeks
Ginseol Kg1(high dose)Drug
1 capsule/day (300mg of Ginseol Kg1), Duration: 8 weeks
PlaceboDrug
1 capsule/day (starch), Duration: 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Ginseol Kg1, high dose | Experimental | Not described Receives: Drug: Ginseol Kg1(high dose) |
| Ginseol Kg1, low dose | Experimental | Not described Receives: Drug: Ginseol Kg1 (low dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of the changes in office diastolic and systolic BP after 8 weeks' treatment between placebo and Ginseol Kg1 group
Measured: baseline and 8 week
Secondary outcomes (5)
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.
Measured: 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.
Measured: baseline and 8 week
The difference of the change in the hs-CRP after 8 weeks' treatment between placebo and Ginseol Kg1 group.
Measured: baseline and 8 week
The difference of the change in the lipid profiles after 8 weeks' treatment between placebo and Ginseol Kg1 group
Measured: 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.
Measured: baseline and 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startSep 2011
- Primary completionJun 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrehypertensionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- DongGuk University
- Responsible party
- Principal investigator, Kwang-il Kim, Seoul National University Hospital
- Investigators
- Kwang-il Kim, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483430
- Sponsor's protocol ID
- CJ_Ginseol Kg1
- Status last verified
- Nov 2011
- First submitted
- 29 Nov 2011
- Last updated
- 2 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Rhee MY, Cho B, Kim KI, Kim J, Kim MK, Lee EK, Kim HJ, Kim CH. Blood pressure lowering effect of Korea ginseng derived ginseol K-g1. Am J Chin Med. 2014;42(3):605-18. doi: 10.1142/S0192415X14500396.
PubMed 24871654
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ginseol Kg1 on Blood Pressure Lowering in Prehypertensive or Stage I Hypertensive Patients: Multicenter, Randomized, Placebo-controlled, Double-blind Study
- ClinicalTrials.gov ID
- NCT01483430
- Acronym / sponsor ID
- CJ_Ginseol Kg1
- Conditions
- Prehypertension, Hypertension, Stage I
- Keywords
- Blood pressure, Korea red ginseng, Ambulatory blood pressure, Pulse wave velocity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- DongGuk University
- Study start
- Sep 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 1 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Ginseol Kg1, high dose | Experimental | Drug: Ginseol Kg1(high dose) |
| Ginseol Kg1, low dose | Experimental | Drug: Ginseol Kg1 (low dose) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ginseol Kg1 (low dose)1 capsule/day (100mg of Ginseol Kg1), Duration: 8 weeks | Drug | Ginseol Kg1, low dose |
| Ginseol Kg1(high dose)1 capsule/day (300mg of Ginseol Kg1), Duration: 8 weeks | Drug | Ginseol Kg1, high dose |
| Placebo1 capsule/day (starch), Duration: 8 weeks | Drug | Placebo |
Primary outcome
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
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2011.
- Derived from this study: PubMed 24871654Rhee MY, Cho B, Kim KI, Kim J, Kim MK, Lee EK, Kim HJ, Kim CH. Blood pressure lowering effect of Korea ginseng derived ginseol K-g1. Am J Chin Med. 2014;42(3):605-18. doi: 10.1142/S0192415X14500396.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwang-il Kim, MD, PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ginseol Kg1 (low dose) and Ginseol Kg1(high dose) in people with Prehypertension and Hypertension, Stage I, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kwang-il Kim, MD, PhD (+82-31-787-7032, kikim907@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01483430, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2011; AzTrials last refreshed its copy on 7 Nov 2026.