Effect of Ginseng in Type 2 Diabetes

October 3, 2016 updated by: Unity Health Toronto

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • : Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
1g/meal of placebo three times per day (3g/day) for 8-weeks.
Dietary supplement: Placebo
Active Comparator: 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.
Dietary supplement: CNT 2000 American ginseng extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1998

Primary Completion (Actual)

December 1, 2001

Study Completion (Actual)

August 1, 2002

Study Registration Dates

First Submitted

October 3, 2016

First Submitted That Met QC Criteria

October 3, 2016

First Posted (Estimate)

October 4, 2016

Study Record Updates

Last Update Posted (Estimate)

October 4, 2016

Last Update Submitted That Met QC Criteria

October 3, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNT 2000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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