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

Hypertension Clinical Trial

— R-KAT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578837
• Other study ID #: OG-2-09-2920-VV
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 2014
• Est. completion date: September 2017

Study information

• Verified date: November 2018
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Hypertension

Intervention

Dietary Supplement:
• Ginseng
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).
• Wheat Bran
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).

Locations

Country	Name	City	State
Canada	Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital	Toronto	Ontario
Croatia	Clinical Centre Vuk Vrhovac	Zagreb

Sponsors (2)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Canadian Diabetes Association

Countries where clinical trial is conducted

Canada,  Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean 24 hour Systolic Ambulatory Blood Pressure at 12 weeks		12 Weeks
Secondary	Change in Mean 24 hour Diastolic, daytime and nighttime Ambulatory Blood pressure at 12 Weeks		12 Weeks
Secondary	Change in Pulse Pressure		12 Weeks
Secondary	Change in Central Augmentation Index and pulse wave analysis		12 Weeks
Secondary	Change in Pulse Wave Velocity at 12 Weeks		12 Weeks
Secondary	Change in low-grade body inflammation (hs-CRP)		12 Weeks
Secondary	Change in HbA1c		12 Weeks
Secondary	Change in Fasting Insulin		12 Weeks
Secondary	Change in Fasting Glucose		12 Weeks
Secondary	Change in Calculated HOMA-Insulin Sensitivity		12 Weeks
Secondary	Change in RHI at 12 weeks	vs control	12 weeks
Secondary	Change in lipids at 12 weeks	vs control	12 weeks