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Completed

NCT Number: NCT01578837

Combined Rg3-enriched Korean Red Ginseng and American Ginseng in the Management of 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.

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Key information

Conditions

Diabetes Mellitus Type 2 Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ginseng

Dietary Supplement

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

Dietary Supplement

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).

Primary outcomes

  1. Change in Mean 24 hour Systolic Ambulatory Blood Pressure at 12 weeks

    Time frame: 12 Weeks

Secondary outcomes

  1. Change in Mean 24 hour Diastolic, daytime and nighttime Ambulatory Blood pressure at 12 Weeks

    Time frame: 12 Weeks

  2. Change in Pulse Pressure

    Time frame: 12 Weeks

  3. Change in Central Augmentation Index and pulse wave analysis

    Time frame: 12 Weeks

  4. Change in Pulse Wave Velocity at 12 Weeks

    Time frame: 12 Weeks

  5. Change in low-grade body inflammation (hs-CRP)

    Time frame: 12 Weeks

  6. Change in HbA1c

    Time frame: 12 Weeks

  7. Change in Fasting Insulin

    Time frame: 12 Weeks

  8. Change in Fasting Glucose

    Time frame: 12 Weeks

  9. Change in Calculated HOMA-Insulin Sensitivity

    Time frame: 12 Weeks

  10. Change in RHI at 12 weeks

    Time frame: 12 weeks

    vs control

  11. Change in lipids at 12 weeks

    Time frame: 12 weeks

    vs control

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • Canadian Diabetes Association

Registry information

Official study 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

Acronym: R-KAT

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 17, 2012
Registry last updated
Nov 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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