Effect of Ginseng on Glycemic Control

Diabetes Clinical Trial

Official title:

Effect of Ginseng on Glycemic Control: A Systematic Review and Meta-analysis of Controlled Trials to Provide Evidence-based Clinical Recommendations

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01841229
• Other study ID #: MetaG
• 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

• Diabetes
• Glucose Intolerance
• Impaired Glucose Tolerance

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