HypertensionPhase 2KRGCBPNCT02211352
Effect of Korean Red Ginseng on Central Blood Pressure in Patient With Essential Hypertension
A Phase 2 study testing Korean Red Ginseng Capsules in people with Hypertension, run by Daegu Catholic University Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to determine Korean red ginseng (KRG)treatment could decrease central blood pressure in subjects with hypertension. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Korean Red Ginseng Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2012to Jul 2014
- Phase
- Phase 2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Essential hypertension
- diastolic blood pressure 100 mmHg or less and systolic blood pressure 160 mmHg or less
Who cannot join
- Secondary hypertension
- Serum creatinin above 1.5 mg/dL
- aspartate aminotransferase(AST) and alanine aminotransferaseALT above two times upper normal limits
- Uncontrolled diabetes (Hb A1c < 9%)
- Acute myocardial infarction or coronary artery disease intervention within six months
- Moderate to severe congestive heart failure
Show all 12Show fewer
- HIV positive
- Immunocompromized host
- Allergy to Korean red ginseng
- Pregnancy or plan to pregnancy
- Alcohol or drug abuse
- Attend to other clinical trial within 12 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Clinical Trial for Effect of Korean Red Ginseng on Central Blood Pressure in Patient With Essential Hypertension
The purpose of this study is to determine Korean red ginseng (KRG)treatment could decrease central blood pressure in subjects with hypertension.
Read the detailed description
Participants with hypertension who were treated with antihypertensive agents were randomly assigned to an active (KRG 2 g/day) or a placebo treatment group in a double-blind cross over manner.
Participants were not allowed to change their antihypertensive medications except safety issue. Brachial systolic BP (SBP), diastolic BP (DBP), Central SBP and DBP will measured at baseline,at 2 and 4 months.
Efficacy and safety data will be monitored by Daegu Catholic University Medical Center Institutional Review Board and reported to the Korean Ginseng Society.
- Conditions
- Hypertension
- Being tested
- Korean Red Ginseng Capsules, Placebo
- Keywords
- blood pressure, ginseng
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Korean Red Ginseng CapsulesDrug
Also called Korean Red Ginseng (KRG) Capsule was manufactured, from roots of a 6-year-old Panax ginseng Meyer.
Korean Red Ginseng Capsules 2mg,daily, 8 week and than crossover to placebo capsules(2g), daily 8week
PlaceboDrug
Also called Placebo of Kerea Red Ginseng(KRG) Capsule
Korean Red Ginseng Capsules 2mg,daily, 8 week and than crossover to placebo capsules(2g), daily 8week
| Study group | Role | What they receive |
|---|---|---|
| Active(Korean Red Ginseng) first group: | Active comparator | Korean Red Ginseng Capsules 2g,daily, 8 week and than crossover to placebo capsules(2g), daily 8week Receives: Drug: Korean Red Ginseng Capsules |
| Placebo capsules | Placebo comparator | placebo Capsules(2g),daily, 8 week and than crossover to Korean Red Ginseng capsules(2g), daily 8week Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
central blood pressure change after treatment of Korea Red Ginseng
Measured: baseline, 8 weeks and 16 weeks after treatment
Secondary outcomes (4)
brachial systolic and diastolic blood pressure
Measured: baseline, 8 week, 16 week.
Augumentation index
Measured: baseline, 8 week, 16 week.
ESR(erythrocyte sedmentation rate)
Measured: baseline, 8 week, 16 week.
CRP(C-reactive protein)
Measured: baseline, 8 week, 16 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startMay 2012
- Primary completionDec 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daegu Catholic University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Korean Society of Ginseng
- Responsible party
- Principal investigator, Jin Bae Lee, Daegu Catholic University Medical Center
- Investigators
- Jin Bae Lee, MD, PhD, Principal investigator, Daegu Catholic University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211352
- Sponsor's protocol ID
- GS302-100
- Other IDs
- GS302-100
- Acronym
- KRGCBP
- Status last verified
- Aug 2014
- First submitted
- 1 May 2013
- Last updated
- 7 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Clinical Trial for Effect of Korean Red Ginseng on Central Blood Pressure in Patient With Essential Hypertension
- ClinicalTrials.gov ID
- NCT02211352
- Acronym / sponsor ID
- KRGCBP / GS302-100
- Conditions
- Hypertension
- Keywords
- blood pressure, ginseng
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Daegu Catholic University Medical CenterUniversity, hospital or other
- Collaborators
- The Korean Society of Ginseng
- Study start
- May 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 7 Aug 2014 (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.
The purpose of this study is to determine Korean red ginseng (KRG)treatment could decrease central blood pressure in subjects with hypertension.
Detailed description
Participants with hypertension who were treated with antihypertensive agents were randomly assigned to an active (KRG 2 g/day) or a placebo treatment group in a double-blind cross over manner.
Participants were not allowed to change their antihypertensive medications except safety issue. Brachial systolic BP (SBP), diastolic BP (DBP), Central SBP and DBP will measured at baseline,at 2 and 4 months.
Efficacy and safety data will be monitored by Daegu Catholic University Medical Center Institutional Review Board and reported to the Korean Ginseng Society.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active(Korean Red Ginseng) first group: | Active comparator | Drug: Korean Red Ginseng CapsulesKorean Red Ginseng Capsules 2g,daily, 8 week and than crossover to placebo capsules(2g), daily 8week |
| Placebo capsules | Placebo comparator | Drug: Placeboplacebo Capsules(2g),daily, 8 week and than crossover to Korean Red Ginseng capsules(2g), daily 8week |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Essential hypertension
- diastolic blood pressure 100 mmHg or less and systolic blood pressure 160 mmHg or less
Key exclusion criteria (12 listed)
- Secondary hypertension
- Serum creatinin above 1.5 mg/dL
- aspartate aminotransferase(AST) and alanine aminotransferaseALT above two times upper normal limits
- Uncontrolled diabetes (Hb A1c < 9%)
- Acute myocardial infarction or coronary artery disease intervention within six months
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 |
|---|---|---|
| Korean Red Ginseng CapsulesAlso: Korean Red Ginseng (KRG) Capsule was manufactured, from roots of a 6-year-old Panax ginseng Meyer.Korean Red Ginseng Capsules 2mg,daily, 8 week and than crossover to placebo capsules(2g), daily 8week | Drug | Active(Korean Red Ginseng) first group: |
| PlaceboAlso: Placebo of Kerea Red Ginseng(KRG) CapsuleKorean Red Ginseng Capsules 2mg,daily, 8 week and than crossover to placebo capsules(2g), daily 8week | Drug | Placebo capsules |
Primary outcome
central blood pressure change after treatment of Korea Red Ginseng
Time frame: baseline, 8 weeks and 16 weeks after treatment
4 secondary outcomes
brachial systolic and diastolic blood pressure
Time frame: baseline, 8 week, 16 week.
Augumentation index
Time frame: baseline, 8 week, 16 week.
ESR(erythrocyte sedmentation rate)
Time frame: baseline, 8 week, 16 week.
CRP(C-reactive protein)
Time frame: baseline, 8 week, 16 week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
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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.
Jin Bae Lee, MD, PhD principal investigator
Daegu Catholic University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Korean Red Ginseng Capsules in people with Hypertension, run by Daegu Catholic University Medical Center 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 2 inclusion and 12 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: finished, as of the sponsor's last update on 7 Aug 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
central blood pressure change after treatment of Korea Red Ginseng (time frame: baseline, 8 weeks and 16 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2014.