Clinical trial NCT01578837: Combined Rg3-enriched Korean Red Ginseng and American Ginseng in the Management of Hypertension in Type 2 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetes Mellitus Type 2
Hypertension
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Diabetes Association
First posted: 2012-04-17
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Mean 24 hour Systolic Ambulatory Blood Pressure at 12 weeks
timeFrame: 12 Weeks
Secondary outcomes:
measure: Change in Mean 24 hour Diastolic, daytime and nighttime Ambulatory Blood pressure at 12 Weeks
timeFrame: 12 Weeks
measure: Change in Pulse Pressure
timeFrame: 12 Weeks
measure: Change in Central Augmentation Index and pulse wave analysis
timeFrame: 12 Weeks
measure: Change in Pulse Wave Velocity at 12 Weeks
timeFrame: 12 Weeks
measure: Change in low-grade body inflammation (hs-CRP)
timeFrame: 12 Weeks
measure: Change in HbA1c
timeFrame: 12 Weeks
measure: Change in Fasting Insulin
timeFrame: 12 Weeks
measure: Change in Fasting Glucose
timeFrame: 12 Weeks
measure: Change in Calculated HOMA-Insulin Sensitivity
timeFrame: 12 Weeks
measure: Change in RHI at 12 weeks
timeFrame: 12 weeks
measure: Change in lipids at 12 weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
state: Ontario
city: Zagreb
country: Croatia
facility: Clinical Centre Vuk Vrhovac
Study officials:
affiliation: Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
name: Vladimir Vuksan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jovanovski E, Smircic-Duvnjak L, Komishon A, Au-Yeung FR, Sievenpiper JL, Zurbau A, Jenkins AL, Sung MK, Josse R, Li D, Vuksan V. Effect of coadministration of enriched Korean Red Ginseng (Panax ginseng) and American ginseng (Panax quinquefolius L) on cardiometabolic outcomes in type-2 diabetes: A randomized controlled trial. J Ginseng Res. 2021 Sep;45(5):546-554. doi: 10.1016/j.jgr.2019.11.005. Epub 2019 Nov 14.