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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by St. Michael's Hospital, Toronto
Sponsor:
Collaborator:
Canadian Diabetes Association
Information provided by (Responsible Party):
Vladimir Vuksan, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01578837
First received: April 12, 2012
Last updated: February 18, 2014
Last verified: February 2014

April 12, 2012
February 18, 2014
April 2012
December 2014   (final data collection date for primary outcome measure)
Change from Baseline in Mean 24 hour Systolic Ambulatory Blood Pressure at 12 weeks [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01578837 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Mean 24 hour Diastolic Ambulatory Blood pressure at 12 Weeks [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change in Pulse Pressure [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change in Central Augmentation Index [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Pulse Wave Velocity at 12 Weeks [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change in low-grade body inflammation (hs-CRP) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change in HbA1c [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change in Fasting Insulin [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change in Fasting Glucose [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change in Calculated HOMA-Insulin Sensitivity [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Combined Rg3-enriched Korean Red Ginseng and American Ginseng in the Management of Hypertension in Type 2 Diabetes
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes Mellitus Type 2
  • Hypertension
  • 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).
  • 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).
  • Experimental: Ginseng
    Combined Rg3-enriched Korean Red Ginseng and American Ginseng capsule
    Intervention: Dietary Supplement: Ginseng
  • Placebo Comparator: Wheat Bran
    100 % Natural Wheat Bran capsule
    Intervention: Dietary Supplement: Wheat Bran
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
June 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
40 Years to 75 Years
No
Contact: Elena Jovanovski, MSc. 416-864-6060 ext 2597 JovanovskiE@smh.ca
Contact: Allison Komishon, MSc.(c) 416-864-6060 ext 5527 KomishonA@smh.ca
Canada,   Croatia
 
NCT01578837
OG-2-09-2920-VV
No
Vladimir Vuksan, St. Michael's Hospital, Toronto
St. Michael's Hospital, Toronto
Canadian Diabetes Association
Principal Investigator: Vladimir Vuksan, PhD Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
St. Michael's Hospital, Toronto
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP