Effect of Ginseng in Type 2 Diabetes

Unity Health Toronto

Status and phase: Completed; Phase 2

Conditions: Type II Diabetes Control

Treatments: Dietary Supplement: CNT 2000 American ginseng extract; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02923453

CNT 2000

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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23 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

1g/meal of placebo three times per day (3g/day) for 8-weeks.

Treatment:

Dietary Supplement: Placebo

Ginseng Extract

Active Comparator group

Description:

CNT2000 (Chai-Na- Ta Corp., Langley, BC) American ginseng extract 1g/meal of placebo three times per day (3g/day) for 8-weeks.

Treatment:

Dietary Supplement: CNT 2000 American ginseng extract