NCT01578837

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Apr 2014

Longer than P75 for phase_1 diabetes-mellitus-type-2

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 17, 2012

Completed
2 years until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

November 21, 2018

Status Verified

November 1, 2018

Enrollment Period

3.4 years

First QC Date

April 12, 2012

Last Update Submit

November 20, 2018

Conditions

Diabetes Mellitus Type 2Hypertension

Outcome Measures

Primary Outcomes (1)

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

    12 Weeks

Secondary Outcomes (11)

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

    12 Weeks

  • Change in Pulse Pressure

    12 Weeks

  • Change in Central Augmentation Index and pulse wave analysis

    12 Weeks

  • Change in Pulse Wave Velocity at 12 Weeks

    12 Weeks

  • Change in low-grade body inflammation (hs-CRP)

    12 Weeks

  • +6 more secondary outcomes

Study Arms (2)

Ginseng

EXPERIMENTAL

Combined Rg3-enriched Korean Red Ginseng and American Ginseng capsule

Dietary Supplement: Ginseng

Wheat Bran

PLACEBO COMPARATOR

100 % Natural Wheat Bran capsule

Dietary Supplement: Wheat Bran

Interventions

GinsengDIETARY_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).

Ginseng
Wheat BranDIETARY_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).

Wheat Bran

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Toronto, Ontario, M5B 1W8, Canada

Location

Clinical Centre Vuk Vrhovac

Zagreb, 10000, Croatia

Location

Related Publications (1)

  • 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.

    PMID: 34803424DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hypertension

Interventions

Asian ginsengDietary Fiber

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Vladimir Vuksan, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2012

First Posted

April 17, 2012

Study Start

April 1, 2014

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

November 21, 2018

Record last verified: 2018-11

Locations

CR(1)CA(1)