- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01841229
Effect of Ginseng on Glycemic Control
May 22, 2013 updated by: Unity Health Toronto
Effect of Ginseng on Glycemic Control: A Systematic Review and Meta-analysis of Controlled Trials to Provide Evidence-based Clinical Recommendations
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]).
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Actual)
770
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
Ontario
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Toronto, Ontario, Canada, M5C 2T2
- The Toronto 3D Knowledge Synthesis and Clinical trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St.Michael's Hospital.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Diabetic (type 1 & type 2) Pre-diabetic Hypertensive Healthy
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Glycated hemoglobin (HbA1c)
Time Frame: 1month
|
1month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Fasting blood glucose
Time Frame: 1month
|
1month
|
|
Fasting plasma insulin
Time Frame: 1 month
|
1 month
|
|
Homeostasis model assessment of insulin resistance (HOMA-IR)
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Anticipated)
May 1, 2013
Study Completion (Anticipated)
May 1, 2013
Study Registration Dates
First Submitted
April 23, 2013
First Submitted That Met QC Criteria
April 25, 2013
First Posted (Estimate)
April 26, 2013
Study Record Updates
Last Update Posted (Estimate)
May 23, 2013
Last Update Submitted That Met QC Criteria
May 22, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MetaG
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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