Effect of Ginseng on Glycemic Control

• Conditions: Impaired Glucose Tolerance; Diabetes

• Registration Number: NCT01841229
• Lead Sponsor: Unity Health Toronto

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-04-25
• Study First Posted: 2013-04-26
• Status Verified: 2013-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-22
• Last Update Posted: 2013-05-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 770

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycated hemoglobin (HbA1c)	1month

Secondary Outcome Measures

Name	Time	Method
Fasting blood glucose	1month
Fasting plasma insulin	1 month
Homeostasis model assessment of insulin resistance (HOMA-IR)	1 month

Trial Locations

Locations (1)

The Toronto 3D Knowledge Synthesis and Clinical trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St.Michael's Hospital.; 🇨🇦 Toronto, Ontario, Canada