Combined Rg3-enriched Korean Red Ginseng and American Ginseng in the Management of Hypertension in Type 2 Diabetes
Phase 1
Completed
- Conditions
- Diabetes Mellitus Type 2Hypertension
- Interventions
- Dietary Supplement: GinsengDietary Supplement: Wheat Bran
- Registration Number
- NCT01578837
- Lead Sponsor
- Unity Health Toronto
- Brief 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ginseng Ginseng Combined Rg3-enriched Korean Red Ginseng and American Ginseng capsule Wheat Bran Wheat Bran 100 % Natural Wheat Bran capsule
- Primary Outcome Measures
Name Time Method Change in Mean 24 hour Systolic Ambulatory Blood Pressure at 12 weeks 12 Weeks
- Secondary Outcome Measures
Name Time Method Change in Pulse Pressure 12 Weeks Change in HbA1c 12 Weeks Change in low-grade body inflammation (hs-CRP) 12 Weeks Change in RHI at 12 weeks 12 weeks vs control
Change in Calculated HOMA-Insulin Sensitivity 12 Weeks Change in Central Augmentation Index and pulse wave analysis 12 Weeks Change in Pulse Wave Velocity at 12 Weeks 12 Weeks Change in lipids at 12 weeks 12 weeks vs control
Change in Mean 24 hour Diastolic, daytime and nighttime Ambulatory Blood pressure at 12 Weeks 12 Weeks Change in Fasting Insulin 12 Weeks Change in Fasting Glucose 12 Weeks
Trial Locations
- Locations (2)
Clinical Centre Vuk Vrhovac
🇭🇷Zagreb, Croatia
Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada