Effect of Ginseng in Type 2 Diabetes

Study Overview
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Brief Summary
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Objective: We aim to evaluate longer term efficacy and safety of AG as an add-on therapy in patients with type 2 diabetes controlled by conventional treatment. Materials and Methods: A total of 23 type 2 patients are enrolled in the study. Utilizing a double-blind, crossover design, the participants are randomized to receive either placebo or American ginseng extract (AG) 1g/meal=3g/day for 8-week, while maintained on their conventional diabetes treatment. Following ≥4-week washout period the participants are crossed over to another 8-week treatment arm. Throughout the study period, all individuals maintain their original diabetes treatment and regular lifestyle. The primary endpoint is HbA1c, and secondary are fasting blood glucose and insulin, blood pressure, serum nitrates/nitrites (NOx) and PAI-1. Safety parameters include liver, kidney and hemostatic functions.

Official Title
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Efficacy and Safety of American Ginseng (Penax Quinquefolius) Extract on Glycemic Control in Individuals With Type 2 Diabetes: A Double-blind, Randomized, Crossover Clinical Trial

Conditions
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Type II Diabetes Control

Intervention / Treatment
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* Dietary Supplement: CNT 2000 American ginseng extract
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of type 2 diabetes of ≥1 year duration BMI between 25-35kg/m^2 HbA1c between 6.5-8.5% Exclusion Criteria: Patients on insulin therapy Impaired hepatic or renal function Clinically manifested diabetic complications Present cardiac problems Uncontrolled hypoglycemia Cigarette smokers Alcohol consumption (>2 drinks per week) Taking ginseng or other herb with possible hypoglycemic effect Involvement in any other investigational drug studies Changed medication during the course of the study periods or during the washout period

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>1g/meal of placebo three times per day (3g/day) for 8-weeks. | Dietary Supplement: Placebo<br> <br> |
| Active Comparator: Ginseng Extract<br>CNT2000 (Chai-Na- Ta Corp., Langley, BC) American ginseng extract 1g/meal of placebo three times per day (3g/day) for 8-weeks. | Dietary Supplement: CNT 2000 American ginseng extract<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood glucose |  | 8 weeks | 
| Fasting blood insulin |  | 8 weeks | 
| Blood pressure |  | 8 weeks | 
| serum nitrates/nitrites (NOx) |  | 8 weeks | 
| Plasminogen activator inhibitor-1 (PAI-1) |  | 8 weeks | 
| Alanine amino-transferase (ALT) |  | 8 weeks | 
| serum creatinine |  | 8 weeks |