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Effect of Ginseng on Glycemic Control

This study is ongoing, but not recruiting participants.
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

Resource links provided by NLM:

U.S. FDA Resources

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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by St. Michael's Hospital, Toronto

Additional 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
Study First Received: April 23, 2013
Last Updated: May 22, 2013
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on March 03, 2015