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Effect of Ginseng on Glycemic Control

Primary Purpose

Impaired Glucose Tolerance, Diabetes

Status
Unknown status
Phase
Locations
Canada
Study Type
Observational
Intervention
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Impaired Glucose Tolerance

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Outcomes

Primary Outcome Measures

Glycated hemoglobin (HbA1c)

Secondary Outcome Measures

Fasting blood glucose
Fasting plasma insulin
Homeostasis model assessment of insulin resistance (HOMA-IR)

Full Information

First Posted
April 23, 2013
Last Updated
May 22, 2013
Sponsor
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01841229
Brief Title
Effect of Ginseng on Glycemic Control
Official Title
Effect of Ginseng on Glycemic Control: A Systematic Review and Meta-analysis of Controlled Trials to Provide Evidence-based Clinical Recommendations
Study Type
Observational

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
May 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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]).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Glucose Tolerance, Diabetes

7. Study Design

Enrollment
770 (Actual)
Primary Outcome Measure Information:
Title
Glycated hemoglobin (HbA1c)
Time Frame
1month
Secondary Outcome Measure Information:
Title
Fasting blood glucose
Time Frame
1month
Title
Fasting plasma insulin
Time Frame
1 month
Title
Homeostasis model assessment of insulin resistance (HOMA-IR)
Time Frame
1 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Study Population Description
Diabetic (type 1 & type 2) Pre-diabetic Hypertensive Healthy
Sampling Method
Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir Vuksan, PhD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Toronto 3D Knowledge Synthesis and Clinical trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St.Michael's Hospital.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 2T2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25265315
Citation
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.
Results Reference
derived

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Effect of Ginseng on Glycemic Control

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