NCT01841229

Brief Summary

Ginseng (American ginseng, Asian ginseng, Korean ginseng etc) is expected to show positive hypoglycemic effects, including improvements in glycated blood proteins\[HbA1c\], fasting glucose, fasting insulin, and the homeostasis model assessment of insulin resistance \[HOMA-IR\]).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
770

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 26, 2013

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 23, 2013

Status Verified

May 1, 2013

Enrollment Period

7 months

First QC Date

April 23, 2013

Last Update Submit

May 22, 2013

Conditions

Impaired Glucose ToleranceDiabetes

Outcome Measures

Primary Outcomes (1)

  • Glycated hemoglobin (HbA1c)

    1month

Secondary Outcomes (3)

  • Fasting blood glucose

    1month

  • Fasting plasma insulin

    1 month

  • Homeostasis model assessment of insulin resistance (HOMA-IR)

    1 month

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Diabetic (type 1 \& type 2) Pre-diabetic Hypertensive Healthy

You may qualify if:

  • Dietary trials in humans
  • Randomized treatment allocation
  • month
  • Suitable control
  • Viable endpoint data

You may not qualify if:

  • Non-human studies
  • Non-randomized treatment allocation
  • \<1 month
  • Lack of a suitable control
  • No viable endpoint data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Toronto 3D Knowledge Synthesis and Clinical trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St.Michael's Hospital.

Toronto, Ontario, M5C 2T2, Canada

Location

Related Publications (1)

  • Shishtar E, Sievenpiper JL, Djedovic V, Cozma AI, Ha V, Jayalath VH, Jenkins DJ, Meija SB, de Souza RJ, Jovanovski E, Vuksan V. The effect of ginseng (the genus panax) on glycemic control: a systematic review and meta-analysis of randomized controlled clinical trials. PLoS One. 2014 Sep 29;9(9):e107391. doi: 10.1371/journal.pone.0107391. eCollection 2014.

    PMID: 25265315DERIVED

MeSH Terms

Conditions

Glucose IntoleranceDiabetes Mellitus

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Vladimir Vuksan, PhD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2013

First Posted

April 26, 2013

Study Start

October 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 23, 2013

Record last verified: 2013-05

Locations

CA(1)