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Effect of Ginseng on Glycemic Control

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2013 by St. Michael's Hospital, Toronto.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01841229
First Posted: April 26, 2013
Last Update Posted: May 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
  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 ]

Secondary Outcome Measures:
  • Fasting blood glucose [ Time Frame: 1month ]
  • Fasting plasma insulin [ Time Frame: 1 month ]
  • Homeostasis model assessment of insulin resistance (HOMA-IR) [ Time Frame: 1 month ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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):
Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01841229     History of Changes
Other Study ID Numbers: MetaG
First Submitted: April 23, 2013
First Posted: April 26, 2013
Last Update Posted: May 23, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases