Diabetes Mellitus Type 2Phase 1/2R-KATNCT01578837
Combined Rg3-enriched Korean Red Ginseng and American Ginseng in the Management of Hypertension in Type 2 Diabetes
A Phase 1/2 study testing Ginseng and Wheat Bran in people with Diabetes Mellitus Type 2 and Hypertension, run by Unity Health Toronto at 2 sites in 2 countries.
Trial summary
The study is a combined Phase-I like (safety) and Phase-II like (efficacy) double blind randomized placebo controlled trial. The objective is to investigate whether the combination of AG and Rg3-enriched Korean Red ginseng added to conventional medical treatment are effective and safe in the long-term management of… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetes Mellitus Type 2, Hypertension
- What is being tested?
- Ginseng and Wheat Bran
- 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
- 2 sitesin 2 countries
- Study dates
- Apr 2014to Sep 2017
- Phase
- Phase 1/2
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between the age of 40 and 75 years
- type 2 diabetes (at least 1 year duration, HbA1c ≥ 6.5%- ≤ 8.0%, treated with diet and/or oral hypoglycemic medications)
- clinically diagnosed and treated hypertension according to Canadian Diabetes Association Clinical Practice Guidelines
- normal thyroid, kidney and liver functions
- female subjects recruited for the study must be post-menopausal or had absence of menstruation for ≥ 1 year or is taking contraceptive precautions
Who cannot join
- insulin therapy
- history of angina, myocardial infarction or stroke
- systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg
- use of ginseng within 1 month start of study
- BMI >35 kg/m2
- smoking cigarettes
Show all 19Show fewer
- alcohol intake of > 2 drinks/day
- recently given blood
- have an upcoming planned surgery
- GFR <60 mL/min/1.73m2
- prolonged QT (>20 ms) interval as assessed by ECG
- changes to use of natural health products that may effect blood pressure and/or diabetes
- weight change more than +/- 3 kg/month
- HIV infection, inflammatory bowel disease, celiac disease, heart disease, bleeding disorder, sleep disorder, arrhythmia
- pregnant or breastfeeding
- use of anticoagulant (excluding aspirin), antiplatelet, sedative, sympathomimetic, photosensitizing or anti-depressant drugs
- hormone replacement therapy, furosemide, morphine, glucocorticoids
- presence of any conditions which, in the opinion of the Qualified Investigator, might jeopardize the health and safety of the subject or study personnel, or adversely affect the study results
- known sensitivity or allergy to any test product or placebo ingredients
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Canada1 site
Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, M5B 1W8
About this study
Official title: Efficacy and Safety of Combined Rg3-enriched Korean Red Ginseng (Panax Ginseng C.A. Meyer) and American Ginseng (Panax Quinquefolius) as Poly-therapy in the Management of Concomitant Hypertension in Type 2 Diabetes
The study is a combined Phase-I like (safety) and Phase-II like (efficacy) double blind randomized placebo controlled trial. The objective is to investigate whether the combination of AG and Rg3-enriched Korean Red ginseng added to conventional medical treatment are effective and safe in the long-term management of high blood pressure while managing type 2 diabetes. Eighty-five subjects with type 2 diabetes and concomitant high blood pressure (key inclusion criteria: HbA1c ≥ 6.5%- ≤ 8.0%) will be recruited for the study.
- Conditions
- Diabetes Mellitus Type 2, Hypertension
- Being tested
- Ginseng, Wheat Bran
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GinsengDietary supplement
2.25g of encapsulated ginseng (1.5g American Ginseng and 0.75g Rg3-enriched Korean Red Ginseng)will be administered in 6 identical capsules, 2 capsules with each meal (total 6 capsules per day).
Wheat BranDietary supplement
2.25g of encapsulated 100% natural wheat bran will be administered in 6 identical capsules, 2 capsules with each meal (total 6 capsules per day).
| Study group | Role | What they receive |
|---|---|---|
| Ginseng | Experimental | Combined Rg3-enriched Korean Red Ginseng and American Ginseng capsule Receives: Dietary Supplement: Ginseng |
| Wheat Bran | Placebo comparator | 100 % Natural Wheat Bran capsule Receives: Dietary Supplement: Wheat Bran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean 24 hour Systolic Ambulatory Blood Pressure at 12 weeks
Measured: 12 Weeks
Secondary outcomes (11)
Change in Mean 24 hour Diastolic, daytime and nighttime Ambulatory Blood pressure at 12 Weeks
Measured: 12 Weeks
Change in Pulse Pressure
Measured: 12 Weeks
Change in Central Augmentation Index and pulse wave analysis
Measured: 12 Weeks
Change in Pulse Wave Velocity at 12 Weeks
Measured: 12 Weeks
Change in low-grade body inflammation (hs-CRP)
Measured: 12 Weeks
Change in HbA1c
Measured: 12 Weeks
Change in Fasting Insulin
Measured: 12 Weeks
Change in Fasting Glucose
Measured: 12 Weeks
Change in Calculated HOMA-Insulin Sensitivity
Measured: 12 Weeks
Change in RHI at 12 weeks
vs control
Measured: 12 weeks
Change in lipids at 12 weeks
vs control
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startApr 2014
- Primary completionSep 2017
- Study completionSep 2017
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 Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Vladimir Vuksan, PhD, Principal investigator, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578837
- Sponsor's protocol ID
- OG-2-09-2920-VV
- Acronym
- R-KAT
- Status last verified
- Nov 2018
- First submitted
- 12 Apr 2012
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Jovanovski E, Smircic-Duvnjak L, Komishon A, Au-Yeung FR, Sievenpiper JL, Zurbau A, Jenkins AL, Sung MK, Josse R, Li D, Vuksan V. Effect of coadministration of enriched Korean Red Ginseng (Panax ginseng) and American ginseng (Panax quinquefolius L) on cardiometabolic outcomes in type-2 diabetes: A randomized controlled trial. J Ginseng Res. 2021 Sep;45(5):546-554. doi: 10.1016/j.jgr.2019.11.005. Epub 2019 Nov 14.
PubMed 34803424
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Combined Rg3-enriched Korean Red Ginseng (Panax Ginseng C.A. Meyer) and American Ginseng (Panax Quinquefolius) as Poly-therapy in the Management of Concomitant Hypertension in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01578837
- Acronym / sponsor ID
- R-KAT / OG-2-09-2920-VV
- Conditions
- Diabetes Mellitus Type 2, Hypertension
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Canadian Diabetes Association
- Study start
- Apr 2014 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 17 Apr 2012 (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 study is a combined Phase-I like (safety) and Phase-II like (efficacy) double blind randomized placebo controlled trial. The objective is to investigate whether the combination of AG and Rg3-enriched Korean Red ginseng added to conventional medical treatment are effective and safe in the long-term management of high blood pressure while managing type 2 diabetes. Eighty-five subjects with type 2 diabetes and concomitant high blood pressure (key inclusion criteria: HbA1c ≥ 6.5%- ≤ 8.0%) will be recruited for the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ginseng | Experimental | Dietary Supplement: GinsengCombined Rg3-enriched Korean Red Ginseng and American Ginseng capsule |
| Wheat Bran | Placebo comparator | Dietary Supplement: Wheat Bran100 % Natural Wheat Bran capsule |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- between the age of 40 and 75 years
- type 2 diabetes (at least 1 year duration, HbA1c ≥ 6.5%- ≤ 8.0%, treated with diet and/or oral hypoglycemic medications)
- clinically diagnosed and treated hypertension according to Canadian Diabetes Association Clinical Practice Guidelines
- normal thyroid, kidney and liver functions
- female subjects recruited for the study must be post-menopausal or had absence of menstruation for ≥ 1 year or is taking contraceptive precautions
Key exclusion criteria (19 listed)
- insulin therapy
- history of angina, myocardial infarction or stroke
- systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg
- use of ginseng within 1 month start of study
- BMI >35 kg/m2
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 |
|---|---|---|
| Ginseng2.25g of encapsulated ginseng (1.5g American Ginseng and 0.75g Rg3-enriched Korean Red Ginseng)will be administered in 6 identical capsules, 2 capsules with each meal (total 6 capsules per day). | Dietary supplement | Ginseng |
| Wheat Bran2.25g of encapsulated 100% natural wheat bran will be administered in 6 identical capsules, 2 capsules with each meal (total 6 capsules per day). | Dietary supplement | Wheat Bran |
Primary outcome
Change in Mean 24 hour Systolic Ambulatory Blood Pressure at 12 weeks
Time frame: 12 Weeks
11 secondary outcomes
Change in Mean 24 hour Diastolic, daytime and nighttime Ambulatory Blood pressure at 12 Weeks
Time frame: 12 Weeks
Change in Pulse Pressure
Time frame: 12 Weeks
Change in Central Augmentation Index and pulse wave analysis
Time frame: 12 Weeks
Change in Pulse Wave Velocity at 12 Weeks
Time frame: 12 Weeks
Change in low-grade body inflammation (hs-CRP)
Time frame: 12 Weeks
Change in HbA1c
Time frame: 12 Weeks
Change in Fasting Insulin
Time frame: 12 Weeks
Change in Fasting Glucose
Time frame: 12 Weeks
Change in Calculated HOMA-Insulin Sensitivity
Time frame: 12 Weeks
Change in RHI at 12 weeks
Time frame: 12 weeks
Change in lipids at 12 weeks
Time frame: 12 weeks
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 21 Nov 2018.
- Derived from this study: PubMed 34803424Jovanovski E, Smircic-Duvnjak L, Komishon A, Au-Yeung FR, Sievenpiper JL, Zurbau A, Jenkins AL, Sung MK, Josse R, Li D, Vuksan V. Effect of coadministration of enriched Korean Red Ginseng (Panax ginseng) and American ginseng (Panax quinquefolius L) on cardiometabolic outcomes in type-2 diabetes: A randomized controlled trial. J Ginseng Res. 2021 Sep;45(5):546-554. doi: 10.1016/j.jgr.2019.11.005. Epub 2019 Nov 14.
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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.
Vladimir Vuksan, PhD principal investigator
Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ginseng and Wheat Bran in people with Diabetes Mellitus Type 2 and Hypertension, run by Unity Health Toronto at 2 sites in 2 countries.
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 5 inclusion and 19 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 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Croatia. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in Mean 24 hour Systolic Ambulatory Blood Pressure at 12 weeks (time frame: 12 Weeks). 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 NCT01578837, 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 21 Nov 2018.