Type II Diabetes Control Clinical Trial
Official title:
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
| Verified date | October 2016 |
| Source | St. Michael's Hospital, Toronto |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Ethics Review Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 23 |
| Est. completion date | August 2002 |
| Est. primary completion date | December 2001 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 45 Years to 75 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | : Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| St. Michael's Hospital, Toronto |
Canada,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c | 8 weeks | No | |
| Secondary | Fasting blood glucose | 8 weeks | No | |
| Secondary | Fasting blood insulin | 8 weeks | No | |
| Secondary | Blood pressure | 8 weeks | No | |
| Secondary | serum nitrates/nitrites (NOx) | 8 weeks | No | |
| Secondary | Plasminogen activator inhibitor-1 (PAI-1) | 8 weeks | No | |
| Secondary | Alanine amino-transferase (ALT) | 8 weeks | Yes | |
| Secondary | serum creatinine | 8 weeks | Yes |