Effect of Ginseng in Type 2 Diabetes

Phase 2

Completed

• Conditions: Type II Diabetes Control
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: CNT 2000 American ginseng extract

• Registration Number: NCT02923453
• Lead Sponsor: Unity Health Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-03
• Primary Completion: 2001-12
• Study Completion: 2002-08
• Status Verified: 2016-10
• Study First Submitted: 2016-10-03
• Study First Submitted QC: 2016-10-03
• Last Update Submitted: 2016-10-03
• Study First Posted: 2016-10-04
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	1g/meal of placebo three times per day (3g/day) for 8-weeks.
Ginseng Extract	CNT 2000 American 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.

Primary Outcome Measures

Name	Time	Method
HbA1c	8 weeks

Secondary Outcome Measures

Name	Time	Method
Fasting blood insulin	8 weeks
Plasminogen activator inhibitor-1 (PAI-1)	8 weeks
serum creatinine	8 weeks
Fasting blood glucose	8 weeks
Blood pressure	8 weeks
serum nitrates/nitrites (NOx)	8 weeks
Alanine amino-transferase (ALT)	8 weeks

Trial Locations

Locations (1)

: Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada