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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
23
: Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, Canada
HbA1c
Time frame: 8 weeks
Fasting blood glucose
Time frame: 8 weeks
Fasting blood insulin
Time frame: 8 weeks
Blood pressure
Time frame: 8 weeks
serum nitrates/nitrites (NOx)
Time frame: 8 weeks
Plasminogen activator inhibitor-1 (PAI-1)
Time frame: 8 weeks
Alanine amino-transferase (ALT)
Time frame: 8 weeks
serum creatinine
Time frame: 8 weeks
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