Effect of Ginseng on Glycemic Control

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2013 by St. Michael's Hospital, Toronto.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by (Responsible Party):

St. Michael's Hospital, Toronto

ClinicalTrials.gov Identifier:

NCT01841229

First received: April 23, 2013

Last updated: May 22, 2013

Last verified: May 2013

History of Changes

Purpose

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]).

Condition
Impaired Glucose Tolerance Diabetes


Study Type:	Observational
Official Title:	Effect of Ginseng on Glycemic Control: A Systematic Review and Meta-analysis of Controlled Trials to Provide Evidence-based Clinical Recommendations

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:

Glycated hemoglobin (HbA1c) [ Time Frame: 1month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Fasting blood glucose [ Time Frame: 1month ] [ Designated as safety issue: No ]
Fasting plasma insulin [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Homeostasis model assessment of insulin resistance (HOMA-IR) [ Time Frame: 1 month ] [ Designated as safety issue: No ]


Enrollment:	770
Study Start Date:	October 2012
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Detailed Description:

Ginseng has demonstrated to have significant hypoglycemic effect. Its major pharmacological component is considered to be ginsenosides. Several trials have been undertaken in diabetes some of which have demonstrated advantages in glycemic control in both diabetic as well as non diabetic individuals although clinical consistency of results is lacking.The lack of high quality data in this area to support diabetes recommendations represents an urgent call for stronger evidence. A systematic review and meta-analysis of controlled trials remains the "Gold Standard" of evidence for recommendations and clinical guidelines development. Therefore, investigators will conduct a systematic review and meta-analyses of controlled trials to assess the effect of ginseng on glycemic control.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01841229

Locations


Canada, Ontario
The Toronto 3D Knowledge Synthesis and Clinical trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St.Michael's Hospital.
Toronto, Ontario, Canada, M5C 2T2

Sponsors and Collaborators

St. Michael's Hospital, Toronto

Investigators


Principal Investigator:	Vladimir Vuksan, PhD	St. Michael's Hospital, Toronto

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Review.


Responsible Party:	St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:	NCT01841229 History of Changes
Other Study ID Numbers:	MetaG
Study First Received:	April 23, 2013
Last Updated:	May 22, 2013
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:


Glucose Intolerance Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases

ClinicalTrials.gov processed this record on September 23, 2016

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