Effect of Ginseng in Type 2 Diabetes

NCT ID: NCT02923453

Last Updated: 2016-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-03-31
• Study Completion Date: 2002-08-31

Brief Summary

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.

Conditions

Type II Diabetes Control

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Ginseng Extract

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

Group Type: ACTIVE_COMPARATOR

CNT 2000 American ginseng extract

Intervention Type: DIETARY_SUPPLEMENT

Interventions

CNT 2000 American ginseng extract

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

: Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital

Toronto, Ontario, Canada

Countries

Canada

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Other Identifiers

CNT 2000

Identifier Type: -

Identifier Source: org_study_id