- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01578837
Combined Rg3-enriched Korean Red Ginseng and American Ginseng in the Management of Hypertension in Type 2 Diabetes (R-KAT)
November 20, 2018 updated by: Unity Health Toronto
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Ginseng
Combined Rg3-enriched Korean Red Ginseng and American Ginseng capsule
|
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).
|
PLACEBO_COMPARATOR: Wheat Bran
100 % Natural Wheat Bran capsule
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Mean 24 hour Systolic Ambulatory Blood Pressure at 12 weeks
Time Frame: 12 Weeks
|
12 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Mean 24 hour Diastolic, daytime and nighttime Ambulatory Blood pressure at 12 Weeks
Time Frame: 12 Weeks
|
12 Weeks
|
|
Change in Pulse Pressure
Time Frame: 12 Weeks
|
12 Weeks
|
|
Change in Central Augmentation Index and pulse wave analysis
Time Frame: 12 Weeks
|
12 Weeks
|
|
Change in Pulse Wave Velocity at 12 Weeks
Time Frame: 12 Weeks
|
12 Weeks
|
|
Change in low-grade body inflammation (hs-CRP)
Time Frame: 12 Weeks
|
12 Weeks
|
|
Change in HbA1c
Time Frame: 12 Weeks
|
12 Weeks
|
|
Change in Fasting Insulin
Time Frame: 12 Weeks
|
12 Weeks
|
|
Change in Fasting Glucose
Time Frame: 12 Weeks
|
12 Weeks
|
|
Change in Calculated HOMA-Insulin Sensitivity
Time Frame: 12 Weeks
|
12 Weeks
|
|
Change in RHI at 12 weeks
Time Frame: 12 weeks
|
vs control
|
12 weeks
|
Change in lipids at 12 weeks
Time Frame: 12 weeks
|
vs control
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Vladimir Vuksan, PhD, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2014
Primary Completion (ACTUAL)
September 1, 2017
Study Completion (ACTUAL)
September 1, 2017
Study Registration Dates
First Submitted
April 12, 2012
First Submitted That Met QC Criteria
April 13, 2012
First Posted (ESTIMATE)
April 17, 2012
Study Record Updates
Last Update Posted (ACTUAL)
November 21, 2018
Last Update Submitted That Met QC Criteria
November 20, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OG-2-09-2920-VV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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