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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
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).
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).
Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, Canada
Clinical Centre Vuk Vrhovac
Zagreb, Croatia
Change in Mean 24 hour Systolic Ambulatory Blood Pressure at 12 weeks
Time frame: 12 Weeks
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
vs control
Time frame: 12 weeks
Change in lipids at 12 weeks
vs control
Time frame: 12 weeks
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