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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
Recruitment status was: Active, not recruiting
Sponsor:
St. Michael's Hospital, Toronto
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
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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) |
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| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01841229
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
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 |
Additional relevant MeSH terms:
|
Glucose Intolerance Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on June 27, 2017