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Effect of Ginseng in Type 2 Diabetes

Primary Purpose

Type II Diabetes Control

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
CNT 2000 American ginseng extract
Placebo
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type II Diabetes Control

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Ginseng Extract

Arm Description

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

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

Outcomes

Primary Outcome Measures

HbA1c

Secondary Outcome Measures

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

Full Information

First Posted
October 3, 2016
Last Updated
October 3, 2016
Sponsor
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02923453
Brief Title
Effect of Ginseng in Type 2 Diabetes
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 1998 (undefined)
Primary Completion Date
December 2001 (Actual)
Study Completion Date
August 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes Control

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1g/meal of placebo three times per day (3g/day) for 8-weeks.
Arm Title
Ginseng Extract
Arm Type
Active Comparator
Arm Description
CNT2000 (Chai-Na- Ta Corp., Langley, BC) American ginseng extract 1g/meal of placebo three times per day (3g/day) for 8-weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
CNT 2000 American ginseng extract
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Fasting blood glucose
Time Frame
8 weeks
Title
Fasting blood insulin
Time Frame
8 weeks
Title
Blood pressure
Time Frame
8 weeks
Title
serum nitrates/nitrites (NOx)
Time Frame
8 weeks
Title
Plasminogen activator inhibitor-1 (PAI-1)
Time Frame
8 weeks
Title
Alanine amino-transferase (ALT)
Time Frame
8 weeks
Title
serum creatinine
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
: Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada

12. IPD Sharing Statement

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Effect of Ginseng in Type 2 Diabetes

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