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

November 20, 2018 updated by: Unity Health Toronto

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

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
      • Zagreb, Croatia, 10000
        • Clinical Centre Vuk Vrhovac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ginseng
Combined Rg3-enriched Korean Red Ginseng and American Ginseng capsule
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).
PLACEBO_COMPARATOR: Wheat Bran
100 % Natural Wheat Bran capsule
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Mean 24 hour Systolic Ambulatory Blood Pressure at 12 weeks
Time Frame: 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
Time Frame: 12 Weeks
12 Weeks
Change in Pulse Pressure
Time Frame: 12 Weeks
12 Weeks
Change in Central Augmentation Index and pulse wave analysis
Time Frame: 12 Weeks
12 Weeks
Change in Pulse Wave Velocity at 12 Weeks
Time Frame: 12 Weeks
12 Weeks
Change in low-grade body inflammation (hs-CRP)
Time Frame: 12 Weeks
12 Weeks
Change in HbA1c
Time Frame: 12 Weeks
12 Weeks
Change in Fasting Insulin
Time Frame: 12 Weeks
12 Weeks
Change in Fasting Glucose
Time Frame: 12 Weeks
12 Weeks
Change in Calculated HOMA-Insulin Sensitivity
Time Frame: 12 Weeks
12 Weeks
Change in RHI at 12 weeks
Time Frame: 12 weeks
vs control
12 weeks
Change in lipids at 12 weeks
Time Frame: 12 weeks
vs control
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Vladimir Vuksan, PhD, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2014

Primary Completion (ACTUAL)

September 1, 2017

Study Completion (ACTUAL)

September 1, 2017

Study Registration Dates

First Submitted

April 12, 2012

First Submitted That Met QC Criteria

April 13, 2012

First Posted (ESTIMATE)

April 17, 2012

Study Record Updates

Last Update Posted (ACTUAL)

November 21, 2018

Last Update Submitted That Met QC Criteria

November 20, 2018

Last Verified

November 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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