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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus Type 2, Hypertension

Intervention / Treatment
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* Dietary Supplement: Ginseng
* Dietary Supplement: Wheat Bran


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ginseng<br>Combined Rg3-enriched Korean Red Ginseng and American Ginseng capsule | Dietary Supplement: Ginseng<br>* 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).<br>|
| Placebo Comparator: Wheat Bran<br>100 % Natural Wheat Bran capsule | Dietary Supplement: Wheat Bran<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean 24 hour Systolic Ambulatory Blood Pressure at 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 |  | 12 Weeks | 
| Change in Pulse Pressure |  | 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 low-grade body inflammation (hs-CRP) |  | 12 Weeks | 
| Change in HbA1c |  | 12 Weeks | 
| Change in Fasting Insulin |  | 12 Weeks | 
| Change in Fasting Glucose |  | 12 Weeks | 
| Change in Calculated HOMA-Insulin Sensitivity |  | 12 Weeks | 
| Change in RHI at 12 weeks | vs control | 12 weeks | 
| Change in lipids at 12 weeks | vs control | 12 weeks |