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OpenTrials
Completed

NCT Number: NCT02923453

Effect of Ginseng in Type 2 Diabetes

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.

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Key information

Conditions

Type II Diabetes Control

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Toronto, Ontario, M5B 1W8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CNT 2000 American ginseng extract

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. HbA1c

    Time frame: 8 weeks

Secondary outcomes

  1. Fasting blood glucose

    Time frame: 8 weeks

  2. Fasting blood insulin

    Time frame: 8 weeks

  3. Blood pressure

    Time frame: 8 weeks

  4. serum nitrates/nitrites (NOx)

    Time frame: 8 weeks

  5. Plasminogen activator inhibitor-1 (PAI-1)

    Time frame: 8 weeks

  6. Alanine amino-transferase (ALT)

    Time frame: 8 weeks

  7. serum creatinine

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study 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

Important dates

Study start
1998
Primary completion
2001
Study completion
2002
First posted
Oct 4, 2016
Registry last updated
Oct 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.