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Combined Rg3-enriched Korean Red Ginseng and American Ginseng in the Management of Hypertension in Type 2 Diabetes (R-KAT)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by St. Michael's Hospital, Toronto.
Recruitment status was:  Recruiting
Canadian Diabetes Association
Information provided by (Responsible Party):
Vladimir Vuksan, St. Michael's Hospital, Toronto Identifier:
First received: April 12, 2012
Last updated: February 18, 2014
Last verified: February 2014
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.

Condition Intervention Phase
Diabetes Mellitus Type 2
Dietary Supplement: Ginseng
Dietary Supplement: Wheat Bran
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Change from Baseline in Mean 24 hour Systolic Ambulatory Blood Pressure at 12 weeks [ Time Frame: 12 Weeks ]

Secondary Outcome Measures:
  • Change from Baseline in Mean 24 hour Diastolic Ambulatory Blood pressure at 12 Weeks [ Time Frame: 12 Weeks ]
  • Change in Pulse Pressure [ Time Frame: 12 Weeks ]
  • Change in Central Augmentation Index [ Time Frame: 12 Weeks ]
  • Change from Baseline 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 ]

Estimated Enrollment: 90
Study Start Date: April 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ginseng
Combined Rg3-enriched Korean Red Ginseng and American Ginseng capsule
Dietary Supplement: Ginseng
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
Dietary Supplement: Wheat Bran
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).


Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01578837

Canada, Ontario
Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Dubrava University Hospital
Zagreb, Croatia, 10000
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Canadian Diabetes Association
Principal Investigator: Vladimir Vuksan, PhD Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
  More Information

Responsible Party: Vladimir Vuksan, Dr. Vladimir Vuksan, St. Michael's Hospital, Toronto Identifier: NCT01578837     History of Changes
Other Study ID Numbers: OG-2-09-2920-VV 
Study First Received: April 12, 2012
Last Updated: February 18, 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on February 20, 2017