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

Unity Health Toronto

Status and phase

Completed

Phase 2

Phase 1

Conditions

Hypertension

Diabetes Mellitus Type 2

Treatments

Dietary Supplement: Wheat Bran

Dietary Supplement: Ginseng

Study type

Interventional

Funder types

Other

Identifiers

NCT01578837

OG-2-09-2920-VV

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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