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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01841229
Other study ID # MetaG
Secondary ID
Status Active, not recruiting
Phase N/A
First received April 23, 2013
Last updated May 22, 2013
Start date October 2012
Est. completion date May 2013

Study information

Verified date May 2013
Source St. Michael's Hospital, Toronto
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial 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]).


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 770
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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 Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
Canada The Toronto 3D Knowledge Synthesis and Clinical trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St.Michael's Hospital. Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glycated hemoglobin (HbA1c) 1month No
Secondary Fasting blood glucose 1month No
Secondary Fasting plasma insulin 1 month No
Secondary Homeostasis model assessment of insulin resistance (HOMA-IR) 1 month No
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