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Effect of Ginseng on Glycemic Control

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ClinicalTrials.gov Identifier: NCT01841229
Recruitment Status : Unknown
Verified May 2013 by St. Michael's Hospital, Toronto.
Recruitment status was:  Active, not recruiting
First Posted : April 26, 2013
Last Update Posted : May 23, 2013
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Study Description
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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]).

Condition or disease
Impaired Glucose Tolerance Diabetes

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.

Study Design
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Study Type : Observational
Actual Enrollment : 770 participants
Official Title: Effect of Ginseng on Glycemic Control: A Systematic Review and Meta-analysis of Controlled Trials to Provide Evidence-based Clinical Recommendations
Study Start Date : October 2012
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : May 2013
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Glycated hemoglobin (HbA1c) [ Time Frame: 1month ]

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

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
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
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Information from the National Library of Medicine

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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
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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 Posted: April 26, 2013    Key Record Dates
Last Update Posted: May 23, 2013
Last Verified: May 2013

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